CBER, CDER, CDRH, CFSAN, CVM, ORA, FDA 2003-09-02T12:55:38+00:00 5667fnl.doc - Microsoft Word guidance, part 11, electronic records, electronic signatures, fda 2003-09-02T12:57:31-03:00 Acrobat PDFWriter 5.0 for Windows NT dob090303 5667fnl.doc - Microsoft Word 2003-09-02T12:55:38Z Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application CBER, CDER, CDRH, CFSAN, CVM, ORA, FDA Acrobat PDFWriter 5.0 for Windows NT dob090303 guidance, part 11, electronic records, electronic signatures, fda 2003-09-02T12:57:31-03:00 2003-09-02T12:55:38Z Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application CBER, CDER, CDRH, CFSAN, CVM, ORA, FDA dob090303 2003-09-02T12:57:31-03:00 2003-09-02T12:57:31-03:00 Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application CBER, CDER, CDRH, CFSAN, CVM, ORA, FDA dob090303 engines={image=false textcolor=true vector=false text=true} tetml={filename={D:\drim\repository\projects\drim_124_0\metadata\9\7\97cd20621783388d4e7838d27b8b749c\97cd20621783388d4e7838d27b8b749c.para.xml} elements={annotations=false bookmarks=false destinations=false fields=false javascripts=false} } granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Guidance G u i d a n c e for f o r Industry I n d u s t r y Part P a r t 11, 1 1 , Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures S i g n a t u r e s — — Scope S c o p e and a n d Application A p p l i c a t i o n U.S. U . S . Department D e p a r t m e n t of o f Health H e a l t h and a n d Human H u m a n Services S e r v i c e s Food F o o d and a n d Drug D r u g Administration A d m i n i s t r a t i o n Center C e n t e r for f o r Drug D r u g Evaluation E v a l u a t i o n and a n d Research R e s e a r c h (CDER) ( C D E R ) Center C e n t e r for f o r Biologics B i o l o g i c s Evaluation E v a l u a t i o n and a n d Research R e s e a r c h (CBER) ( C B E R ) Center C e n t e r for f o r Devices D e v i c e s and a n d Radiological R a d i o l o g i c a l Health H e a l t h (CDRH) ( C D R H ) Center C e n t e r for f o r Food F o o d Safety S a f e t y and a n d Applied A p p l i e d Nutrition N u t r i t i o n (CFSAN) ( C F S A N ) Center C e n t e r for f o r Veterinary V e t e r i n a r y Medicine M e d i c i n e (CVM) ( C V M ) Office O f f i c e of o f Regulatory R e g u l a t o r y Affairs A f f a i r s (ORA) ( O R A ) August A u g u s t 2003 2 0 0 3 Pharmaceutical P h a r m a c e u t i c a l CGMPs C G M P s granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Guidance G u i d a n c e for f o r Industry I n d u s t r y Part P a r t 11, 1 1 , Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures S i g n a t u r e s — — Scope S c o p e and a n d Application A p p l i c a t i o n Division D i v i s i o n of o f Drug D r u g Information, I n f o r m a t i o n , HFD-240 H F D - 2 4 0 Center C e n t e r for f o r Drug D r u g Evaluation E v a l u a t i o n and a n d Research R e s e a r c h (CDER) ( C D E R ) (Tel) ( T e l ) 301-827-4573 3 0 1 - 8 2 7 - 4 5 7 3 http://www.fda.gov/cder/guidance/index.htm h t t p : / / w w w . f d a . g o v / c d e r / g u i d a n c e / i n d e x . h t m or o r Office O f f i c e of o f Communication, C o m m u n i c a t i o n , Training T r a i n i n g and a n d Manufacturers M a n u f a c t u r e r s Assistance, A s s i s t a n c e , HFM-40 H F M - 4 0 Center C e n t e r for f o r Biologics B i o l o g i c s Evaluation E v a l u a t i o n and a n d Research R e s e a r c h (CBER) ( C B E R ) http://www.fda.gov/cber/guidelines.htm h t t p : / / w w w . f d a . g o v / c b e r / g u i d e l i n e s . h t m Phone: P h o n e : the t h e Voice V o i c e Information I n f o r m a t i o n System S y s t e m at a t 800-835-4709 8 0 0 - 8 3 5 - 4 7 0 9 or o r 301-827-1800 3 0 1 - 8 2 7 - 1 8 0 0 or o r Communications C o m m u n i c a t i o n s Staff S t a f f (HFV-12), ( H F V - 1 2 ) , Center C e n t e r for f o r Veterinary V e t e r i n a r y Medicine M e d i c i n e (CVM) ( C V M ) (Tel) ( T e l ) 301-594-1755 3 0 1 - 5 9 4 - 1 7 5 5 http://www.fda.gov/cvm/guidance/guidance.html h t t p : / / w w w . f d a . g o v / c v m / g u i d a n c e / g u i d a n c e . h t m l or o r Division D i v i s i o n of o f Small S m a l l Manufacturers M a n u f a c t u r e r s Assistance A s s i s t a n c e (HFZ-220) ( H F Z - 2 2 0 ) http://www.fda.gov/cdrh/ggpmain.html h t t p : / / w w w . f d a . g o v / c d r h / g g p m a i n . h t m l Manufacturers M a n u f a c t u r e r s Assistance A s s i s t a n c e Phone P h o n e Number: N u m b e r : 800.638.2041 8 0 0 . 6 3 8 . 2 0 4 1 or o r 301.443.6597 3 0 1 . 4 4 3 . 6 5 9 7 Internt'l I n t e r n t ' l Staff S t a f f Phone: P h o n e : 301.827.3993 3 0 1 . 8 2 7 . 3 9 9 3 or o r Center C e n t e r for f o r Food F o o d Safety S a f e t y and a n d Applied A p p l i e d Nutrition N u t r i t i o n (CFSAN) ( C F S A N ) http://www.cfsan.fda.gov/~dms/guidance.html. h t t p : / / w w w . c f s a n . f d a . g o v / ~ d m s / g u i d a n c e . h t m l . U.S. U . S . Department D e p a r t m e n t of o f Health H e a l t h and a n d Human H u m a n Services S e r v i c e s Food F o o d and a n d Drug D r u g Administration A d m i n i s t r a t i o n Center C e n t e r for f o r Drug D r u g Evaluation E v a l u a t i o n and a n d Research R e s e a r c h (CDER) ( C D E R ) Center C e n t e r for f o r Biologics B i o l o g i c s Evaluation E v a l u a t i o n and a n d Research R e s e a r c h (CBER) ( C B E R ) Center C e n t e r for f o r Devices D e v i c e s and a n d Radiological R a d i o l o g i c a l Health H e a l t h (CDRH) ( C D R H ) Center C e n t e r for f o r Food F o o d Safety S a f e t y and a n d Applied A p p l i e d Nutrition N u t r i t i o n (CFSAN) ( C F S A N ) Center C e n t e r for f o r Veterinary V e t e r i n a r y Medicine M e d i c i n e (CVM) ( C V M ) Office O f f i c e of o f Regulatory R e g u l a t o r y Affairs A f f a i r s (ORA) ( O R A ) August A u g u s t 2003 2 0 0 3 Pharmaceutical P h a r m a c e u t i c a l CGMPs C G M P s granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} TABLE T A B L E OF O F CONTENTS C O N T E N T S I. I . INTRODUCTION............................................................................................................. I N T R O D U C T I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 II. I I . BACKGROUND B A C K G R O U N D ............................................................................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2 III. I I I . DISCUSSION D I S C U S S I O N .................................................................................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 A. A . Overall O v e r a l l Approach A p p r o a c h to t o Part P a r t 11 1 1 Requirements R e q u i r e m e n t s ......................................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 B. B . Details D e t a i l s of o f Approach A p p r o a c h – – Scope S c o p e of o f Part P a r t 11................................................................................ 1 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 1. 1 . Narrow N a r r o w Interpretation I n t e r p r e t a t i o n of o f Scope............................................................................................. S c o p e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 2. 2 . Definition D e f i n i t i o n of o f Part P a r t 11 1 1 Records................................................................................................ R e c o r d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5 C. C . Approach A p p r o a c h to t o Specific S p e c i f i c Part P a r t 11 1 1 Requirements R e q u i r e m e n t s ........................................................................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6 1. 1 . Validation V a l i d a t i o n ............................................................................................................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6 2. 2 . Audit A u d i t Trail T r a i l ............................................................................................................................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6 3. 3 . Legacy L e g a c y Systems...................................................................................................................... S y s t e m s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 7 4. 4 . Copies C o p i e s of o f Records.................................................................................................................. R e c o r d s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 7 5. 5 . Record R e c o r d Retention R e t e n t i o n ................................................................................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 8 IV. I V . REFERENCES.................................................................................................................. R E F E R E N C E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 10 1 0 11 1 1 12 1 2 13 1 3 14 1 4 15 1 5 16 1 6 17 1 7 18 1 8 19 1 9 20 2 0 21 2 1 22 2 2 23 2 3 24 2 4 25 2 5 26 2 6 27 2 7 28 2 8 29 2 9 30 3 0 31 3 1 32 3 2 Guidance G u i d a n c e for f o r Industry I n d u s t r y 1 1 Part P a r t 11, 1 1 , Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures S i g n a t u r e s — — Scope S c o p e and a n d Application A p p l i c a t i o n This T h i s guidance g u i d a n c e represents r e p r e s e n t s the t h e Food F o o d and a n d Drug D r u g Administration's A d m i n i s t r a t i o n ' s (FDA's) ( F D A ' s ) current c u r r e n t thinking t h i n k i n g on o n this t h i s topic. t o p i c . It I t does d o e s not n o t create c r e a t e or o r confer c o n f e r any a n y rights r i g h t s for f o r or o r on o n any a n y person p e r s o n and a n d does d o e s not n o t operate o p e r a t e to t o bind b i n d FDA F D A or o r the t h e public. p u b l i c . You Y o u can c a n use u s e an a n alternative a l t e r n a t i v e approach a p p r o a c h if i f the t h e approach a p p r o a c h satisfies s a t i s f i e s the t h e requirements r e q u i r e m e n t s of o f the t h e applicable a p p l i c a b l e statutes s t a t u t e s and a n d regulations. r e g u l a t i o n s . If I f you y o u want w a n t to t o discuss d i s c u s s an a n alternative a l t e r n a t i v e approach, a p p r o a c h , contact c o n t a c t the t h e FDA F D A staff s t a f f responsible r e s p o n s i b l e for f o r implementing i m p l e m e n t i n g this t h i s guidance. g u i d a n c e . If I f you y o u cannot c a n n o t identify i d e n t i f y the t h e appropriate a p p r o p r i a t e FDA F D A staff, s t a f f , call c a l l the t h e appropriate a p p r o p r i a t e number n u m b e r listed l i s t e d on o n the t h e title t i t l e page p a g e of o f this t h i s guidance. g u i d a n c e . I. I . INTRODUCTION I N T R O D U C T I O N This T h i s guidance g u i d a n c e is i s intended i n t e n d e d to t o describe d e s c r i b e the t h e Food F o o d and a n d Drug D r u g Administration's A d m i n i s t r a t i o n ' s (FDA’s) ( F D A ’ s ) current c u r r e n t thinking t h i n k i n g regarding r e g a r d i n g the t h e scope s c o p e and a n d application a p p l i c a t i o n of o f part p a r t 11 1 1 of o f Title T i t l e 21 2 1 of o f the t h e Code C o d e of o f Federal F e d e r a l Regulations; R e g u l a t i o n s ; Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures S i g n a t u r e s (21 ( 2 1 CFR C F R Part P a r t 11). 1 1 ) . 2 2 This T h i s document d o c u m e n t provides p r o v i d e s guidance g u i d a n c e to t o persons p e r s o n s who, w h o , in i n fulfillment f u l f i l l m e n t of o f a a requirement r e q u i r e m e n t in i n a a statute s t a t u t e or o r another a n o t h e r part p a r t of o f FDA's F D A ' s regulations r e g u l a t i o n s to t o maintain m a i n t a i n records r e c o r d s or o r submit s u b m i t information i n f o r m a t i o n to t o FDA, F D A , 3 3 have h a v e chosen c h o s e n to t o maintain m a i n t a i n the t h e records r e c o r d s or o r submit s u b m i t designated d e s i g n a t e d information i n f o r m a t i o n electronically e l e c t r o n i c a l l y and, a n d , as a s a a result, r e s u l t , have h a v e become b e c o m e subject s u b j e c t to t o part p a r t 11. 1 1 . Part P a r t 11 1 1 applies a p p l i e s to t o records r e c o r d s in i n electronic e l e c t r o n i c form f o r m that t h a t are a r e created, c r e a t e d , modified, m o d i f i e d , maintained, m a i n t a i n e d , archived, a r c h i v e d , retrieved, r e t r i e v e d , or o r transmitted t r a n s m i t t e d under u n d e r any a n y records r e c o r d s requirements r e q u i r e m e n t s set s e t forth f o r t h in i n Agency A g e n c y regulations. r e g u l a t i o n s . Part P a r t 11 1 1 also a l s o applies a p p l i e s to t o electronic e l e c t r o n i c records r e c o r d s submitted s u b m i t t e d to t o the t h e Agency A g e n c y under u n d e r the t h e Federal F e d e r a l Food, F o o d , Drug, D r u g , and a n d Cosmetic C o s m e t i c Act A c t (the ( t h e Act) A c t ) and a n d the t h e Public P u b l i c Health H e a l t h Service S e r v i c e Act A c t (the ( t h e PHS P H S Act), A c t ) , even e v e n if i f such s u c h records r e c o r d s are a r e not n o t specifically s p e c i f i c a l l y identified i d e n t i f i e d in i n Agency A g e n c y regulations r e g u l a t i o n s (§ ( § 11.1). 1 1 . 1 ) . The T h e underlying u n d e r l y i n g requirements r e q u i r e m e n t s set s e t forth f o r t h in i n the t h e Act, A c t , PHS P H S Act, A c t , and a n d FDA F D A regulations r e g u l a t i o n s (other ( o t h e r than t h a n part p a r t 11) 1 1 ) are a r e referred r e f e r r e d to t o in i n this t h i s guidance g u i d a n c e document d o c u m e n t as a s predicate p r e d i c a t e rules. r u l e s . 1 1 This T h i s guidance g u i d a n c e has h a s been b e e n prepared p r e p a r e d by b y the t h e Office O f f i c e of o f Compliance C o m p l i a n c e in i n the t h e Center C e n t e r for f o r Drug D r u g Evaluation E v a l u a t i o n and a n d Research R e s e a r c h (CDER) ( C D E R ) in i n consultation c o n s u l t a t i o n with w i t h the t h e other o t h e r Agency A g e n c y centers c e n t e r s and a n d the t h e Office O f f i c e of o f Regulatory R e g u l a t o r y Affairs A f f a i r s at a t the t h e Food F o o d and a n d Drug D r u g Administration. A d m i n i s t r a t i o n . 2 2 62 6 2 FR F R 13430 1 3 4 3 0 3 3 These T h e s e requirements r e q u i r e m e n t s include, i n c l u d e , for f o r example, e x a m p l e , certain c e r t a i n provisions p r o v i s i o n s of o f the t h e Current C u r r e n t Good G o o d Manufacturing M a n u f a c t u r i n g Practice P r a c t i c e regulations r e g u l a t i o n s (21 ( 2 1 CFR C F R Part P a r t 211), 2 1 1 ) , the t h e Quality Q u a l i t y System S y s t e m regulation r e g u l a t i o n (21 ( 2 1 CFR C F R Part P a r t 820), 8 2 0 ) , and a n d the t h e Good G o o d Laboratory L a b o r a t o r y Practice P r a c t i c e for f o r Nonclinical N o n c l i n i c a l Laboratory L a b o r a t o r y Studies S t u d i e s regulations r e g u l a t i o n s (21 ( 2 1 CFR C F R Part P a r t 58). 5 8 ) . 1 1 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 33 3 3 34 3 4 35 3 5 36 3 6 37 3 7 38 3 8 39 3 9 40 4 0 41 4 1 42 4 2 43 4 3 44 4 4 45 4 5 46 4 6 47 4 7 48 4 8 49 4 9 50 5 0 51 5 1 52 5 2 53 5 3 54 5 4 55 5 5 56 5 6 57 5 7 58 5 8 59 5 9 60 6 0 61 6 1 62 6 2 63 6 3 64 6 4 65 6 5 66 6 6 67 6 7 68 6 8 69 6 9 70 7 0 71 7 1 72 7 2 73 7 3 74 7 4 As A s an a n outgrowth o u t g r o w t h of o f its i t s current c u r r e n t good g o o d manufacturing m a n u f a c t u r i n g practice p r a c t i c e (CGMP) ( C G M P ) initiative i n i t i a t i v e for f o r human h u m a n and a n d animal a n i m a l drugs d r u g s and a n d biologics, b i o l o g i c s , 4 4 FDA F D A is i s re-examining r e - e x a m i n i n g part p a r t 11 1 1 as a s it i t applies a p p l i e s to t o all a l l FDA F D A regulated r e g u l a t e d products. p r o d u c t s . We W e anticipate a n t i c i p a t e initiating i n i t i a t i n g rulemaking r u l e m a k i n g to t o change c h a n g e part p a r t 11 1 1 as a s a a result r e s u l t of o f that t h a t re- r e - examination. e x a m i n a t i o n . This T h i s guidance g u i d a n c e explains e x p l a i n s that t h a t we w e will w i l l narrowly n a r r o w l y interpret i n t e r p r e t the t h e scope s c o p e of o f part p a r t 11. 1 1 . While W h i l e the t h e re-examination r e - e x a m i n a t i o n of o f part p a r t 11 1 1 is i s under u n d e r way, w a y , we w e intend i n t e n d to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n with w i t h respect r e s p e c t to t o certain c e r t a i n part p a r t 11 1 1 requirements. r e q u i r e m e n t s . That T h a t is, i s , we w e do d o not n o t intend i n t e n d to t o take t a k e enforcement e n f o r c e m e n t action a c t i o n to t o enforce e n f o r c e compliance c o m p l i a n c e with w i t h the t h e validation, v a l i d a t i o n , audit a u d i t trail, t r a i l , record r e c o r d retention, r e t e n t i o n , and a n d record r e c o r d copying c o p y i n g requirements r e q u i r e m e n t s of o f part p a r t 11 1 1 as a s explained e x p l a i n e d in i n this t h i s guidance. g u i d a n c e . However, H o w e v e r , records r e c o r d s must m u s t still s t i l l be b e maintained m a i n t a i n e d or o r submitted s u b m i t t e d in i n accordance a c c o r d a n c e with w i t h the t h e underlying u n d e r l y i n g predicate p r e d i c a t e rules, r u l e s , and a n d the t h e Agency A g e n c y can c a n take t a k e regulatory r e g u l a t o r y action a c t i o n for f o r noncompliance n o n c o m p l i a n c e with w i t h such s u c h predicate p r e d i c a t e rules. r u l e s . In I n addition, a d d i t i o n , we w e intend i n t e n d to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n and a n d do d o not n o t intend i n t e n d to t o take t a k e (or ( o r recommend) r e c o m m e n d ) action a c t i o n to t o enforce e n f o r c e any a n y part p a r t 11 1 1 requirements r e q u i r e m e n t s with w i t h regard r e g a r d to t o systems s y s t e m s that t h a t were w e r e operational o p e r a t i o n a l before b e f o r e August A u g u s t 20, 2 0 , 1997, 1 9 9 7 , the t h e effective e f f e c t i v e date d a t e of o f part p a r t 11 1 1 (commonly ( c o m m o n l y known k n o w n as a s legacy l e g a c y systems) s y s t e m s ) under u n d e r the t h e circumstances c i r c u m s t a n c e s described d e s c r i b e d in i n section s e c t i o n III.C.3 I I I . C . 3 of o f this t h i s guidance. g u i d a n c e . Note N o t e that t h a t part p a r t 11 1 1 remains r e m a i n s in i n effect e f f e c t and a n d that t h a t this t h i s exercise e x e r c i s e of o f enforcement e n f o r c e m e n t discretion d i s c r e t i o n applies a p p l i e s only o n l y as a s identified i d e n t i f i e d in i n this t h i s guidance. g u i d a n c e . FDA's F D A ' s guidance g u i d a n c e documents, d o c u m e n t s , including i n c l u d i n g this t h i s guidance, g u i d a n c e , do d o not n o t establish e s t a b l i s h legally l e g a l l y enforceable e n f o r c e a b l e responsibilities. r e s p o n s i b i l i t i e s . Instead, I n s t e a d , guidances g u i d a n c e s describe d e s c r i b e the t h e Agency's A g e n c y ' s current c u r r e n t thinking t h i n k i n g on o n a a topic t o p i c and a n d should s h o u l d be b e viewed v i e w e d only o n l y as a s recommendations, r e c o m m e n d a t i o n s , unless u n l e s s specific s p e c i f i c regulatory r e g u l a t o r y or o r statutory s t a t u t o r y requirements r e q u i r e m e n t s are a r e cited. c i t e d . The T h e use u s e of o f the t h e word w o r d should s h o u l d in i n Agency A g e n c y guidances g u i d a n c e s means m e a n s that t h a t something s o m e t h i n g is i s suggested s u g g e s t e d or o r recommended, r e c o m m e n d e d , but b u t not n o t required. r e q u i r e d . II. I I . BACKGROUND B A C K G R O U N D In I n March M a r c h of o f 1997, 1 9 9 7 , FDA F D A issued i s s u e d final f i n a l part p a r t 11 1 1 regulations r e g u l a t i o n s that t h a t provide p r o v i d e criteria c r i t e r i a for f o r acceptance a c c e p t a n c e by b y FDA, F D A , under u n d e r certain c e r t a i n circumstances, c i r c u m s t a n c e s , of o f electronic e l e c t r o n i c records, r e c o r d s , electronic e l e c t r o n i c signatures, s i g n a t u r e s , and a n d handwritten h a n d w r i t t e n signatures s i g n a t u r e s executed e x e c u t e d to t o electronic e l e c t r o n i c records r e c o r d s as a s equivalent e q u i v a l e n t to t o paper p a p e r records r e c o r d s and a n d handwritten h a n d w r i t t e n signatures s i g n a t u r e s executed e x e c u t e d on o n paper. p a p e r . These T h e s e regulations, r e g u l a t i o n s , which w h i c h apply a p p l y to t o all a l l FDA F D A program p r o g r a m areas, a r e a s , were w e r e intended i n t e n d e d to t o permit p e r m i t the t h e widest w i d e s t possible p o s s i b l e use u s e of o f electronic e l e c t r o n i c technology, t e c h n o l o g y , compatible c o m p a t i b l e with w i t h FDA's F D A ' s responsibility r e s p o n s i b i l i t y to t o protect p r o t e c t the t h e public p u b l i c health. h e a l t h . After A f t e r part p a r t 11 1 1 became b e c a m e effective e f f e c t i v e in i n August A u g u s t 1997, 1 9 9 7 , significant s i g n i f i c a n t discussions d i s c u s s i o n s ensued e n s u e d among a m o n g industry, i n d u s t r y , contractors, c o n t r a c t o r s , and a n d the t h e Agency A g e n c y concerning c o n c e r n i n g the t h e interpretation i n t e r p r e t a t i o n and a n d implementation i m p l e m e n t a t i o n of o f the t h e regulations. r e g u l a t i o n s . FDA F D A has h a s (1) ( 1 ) spoken s p o k e n about a b o u t part p a r t 11 1 1 at a t many m a n y conferences c o n f e r e n c e s and a n d met m e t numerous n u m e r o u s times t i m e s with w i t h an a n industry i n d u s t r y coalition c o a l i t i o n and a n d other o t h e r interested i n t e r e s t e d parties p a r t i e s in i n an a n effort e f f o r t to t o hear h e a r more m o r e about a b o u t potential p o t e n t i a l part p a r t 11 1 1 issues; i s s u e s ; (2) ( 2 ) published p u b l i s h e d a a compliance c o m p l i a n c e policy p o l i c y guide, g u i d e , CPG C P G 7153.17: 7 1 5 3 . 1 7 : Enforcement E n f o r c e m e n t Policy: P o l i c y : 21 2 1 CFR C F R Part P a r t 11; 1 1 ; Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures; S i g n a t u r e s ; and a n d (3) ( 3 ) published p u b l i s h e d numerous n u m e r o u s draft d r a f t guidance g u i d a n c e documents d o c u m e n t s including i n c l u d i n g the t h e following: f o l l o w i n g : 4 4 See S e e Pharmaceutical P h a r m a c e u t i c a l CGMPs C G M P s for f o r the t h e 21st 2 1 s t Century: C e n t u r y : A A Risk-Based R i s k - B a s e d Approach; A p p r o a c h ; A A Science S c i e n c e and a n d Risk R i s k -Based - B a s e d Approach A p p r o a c h to t o Product P r o d u c t Quality Q u a l i t y Regulation R e g u l a t i o n Incorporating I n c o r p o r a t i n g an a n Integrated I n t e g r a t e d Quality Q u a l i t y Systems S y s t e m s Approach A p p r o a c h at a t www.fda.gov/oc/guidance/gmp.html. w w w . f d a . g o v / o c / g u i d a n c e / g m p . h t m l . 2 2 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 75 7 5 76 7 6 77 7 7 78 7 8 79 7 9 80 8 0 81 8 1 82 8 2 83 8 3 84 8 4 85 8 5 86 8 6 87 8 7 88 8 8 89 8 9 90 9 0 91 9 1 92 9 2 93 9 3 94 9 4 95 9 5 96 9 6 97 9 7 98 9 8 99 9 9 100 1 0 0 101 1 0 1 102 1 0 2 103 1 0 3 104 1 0 4 105 1 0 5 106 1 0 6 107 1 0 7 108 1 0 8 109 1 0 9 110 1 1 0 111 1 1 1 112 1 1 2 113 1 1 3 114 1 1 4 115 1 1 5 • • 21 2 1 CFR C F R Part P a r t 11; 1 1 ; Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures, S i g n a t u r e s , Validation V a l i d a t i o n • • 21 2 1 CFR C F R Part P a r t 11; 1 1 ; Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures, S i g n a t u r e s , Glossary G l o s s a r y of o f Terms T e r m s • • 21 2 1 CFR C F R Part P a r t 11; 1 1 ; Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures, S i g n a t u r e s , Time T i m e Stamps S t a m p s • • 21 2 1 CFR C F R Part P a r t 11; 1 1 ; Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures, S i g n a t u r e s , Maintenance M a i n t e n a n c e of o f Electronic E l e c t r o n i c Records R e c o r d s • • 21 2 1 CFR C F R Part P a r t 11; 1 1 ; Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures, S i g n a t u r e s , Electronic E l e c t r o n i c Copies C o p i e s of o f Electronic E l e c t r o n i c Records R e c o r d s Throughout T h r o u g h o u t all a l l of o f these t h e s e communications, c o m m u n i c a t i o n s , concerns c o n c e r n s have h a v e been b e e n raised r a i s e d that t h a t some s o m e interpretations i n t e r p r e t a t i o n s of o f the t h e part p a r t 11 1 1 requirements r e q u i r e m e n t s would w o u l d (1) ( 1 ) unnecessarily u n n e c e s s a r i l y restrict r e s t r i c t the t h e use u s e of o f electronic e l e c t r o n i c technology t e c h n o l o g y in i n a a manner m a n n e r that t h a t is i s inconsistent i n c o n s i s t e n t with w i t h FDA's F D A ' s stated s t a t e d intent i n t e n t in i n issuing i s s u i n g the t h e rule, r u l e , (2) ( 2 ) significantly s i g n i f i c a n t l y increase i n c r e a s e the t h e costs c o s t s of o f compliance c o m p l i a n c e to t o an a n extent e x t e n t that t h a t was w a s not n o t contemplated c o n t e m p l a t e d at a t the t h e time t i m e the t h e rule r u l e was w a s drafted, d r a f t e d , and a n d (3) ( 3 ) discourage d i s c o u r a g e innovation i n n o v a t i o n and a n d technological t e c h n o l o g i c a l advances a d v a n c e s without w i t h o u t providing p r o v i d i n g a a significant s i g n i f i c a n t public p u b l i c health h e a l t h benefit. b e n e f i t . These T h e s e concerns c o n c e r n s have h a v e been b e e n raised r a i s e d particularly p a r t i c u l a r l y in i n the t h e areas a r e a s of o f part p a r t 11 1 1 requirements r e q u i r e m e n t s for f o r validation, v a l i d a t i o n , audit a u d i t trails, t r a i l s , record r e c o r d retention, r e t e n t i o n , record r e c o r d copying, c o p y i n g , and a n d legacy l e g a c y systems. s y s t e m s . As A s a a result r e s u l t of o f these t h e s e concerns, c o n c e r n s , we w e decided d e c i d e d to t o review r e v i e w the t h e part p a r t 11 1 1 documents d o c u m e n t s and a n d related r e l a t e d issues, i s s u e s , particularly p a r t i c u l a r l y in i n light l i g h t of o f the t h e Agency's A g e n c y ' s CGMP C G M P initiative. i n i t i a t i v e . In I n the t h e Federal F e d e r a l Register R e g i s t e r of o f February F e b r u a r y 4, 4 , 2003 2 0 0 3 (68 ( 6 8 FR F R 5645), 5 6 4 5 ) , we w e announced a n n o u n c e d the t h e withdrawal w i t h d r a w a l of o f the t h e draft d r a f t guidance g u i d a n c e for f o r industry, i n d u s t r y , 21 2 1 CFR C F R Part P a r t 11; 1 1 ; Electronic E l e c t r o n i c Records; R e c o r d s ; Electronic E l e c t r o n i c Signatures, S i g n a t u r e s , Electronic E l e c t r o n i c Copies C o p i e s of o f Electronic E l e c t r o n i c Records. R e c o r d s . We W e had h a d decided d e c i d e d we w e wanted w a n t e d to t o minimize m i n i m i z e industry i n d u s t r y time t i m e spent s p e n t reviewing r e v i e w i n g and a n d commenting c o m m e n t i n g on o n the t h e draft d r a f t guidance g u i d a n c e when w h e n that t h a t draft d r a f t guidance g u i d a n c e may m a y no n o longer l o n g e r represent r e p r e s e n t our o u r approach a p p r o a c h under u n d e r the t h e CGMP C G M P initiative. i n i t i a t i v e . Then, T h e n , in i n the t h e Federal F e d e r a l Register R e g i s t e r of o f February F e b r u a r y 25, 2 5 , 2003 2 0 0 3 (68 ( 6 8 FR F R 8775), 8 7 7 5 ) , we w e announced a n n o u n c e d the t h e withdrawal w i t h d r a w a l of o f the t h e part p a r t 11 1 1 draft d r a f t guidance g u i d a n c e documents d o c u m e n t s on o n validation, v a l i d a t i o n , glossary g l o s s a r y of o f terms, t e r m s , time t i m e stamps, s t a m p s , 5 5 maintenance m a i n t e n a n c e of o f electronic e l e c t r o n i c records, r e c o r d s , and a n d CPG C P G 7153.17. 7 1 5 3 . 1 7 . We W e received r e c e i v e d valuable v a l u a b l e public p u b l i c comments c o m m e n t s on o n these t h e s e draft d r a f t guidances, g u i d a n c e s , and a n d we w e plan p l a n to t o use u s e that t h a t information i n f o r m a t i o n to t o help h e l p with w i t h future f u t u r e decision-making d e c i s i o n - m a k i n g with w i t h respect r e s p e c t to t o part p a r t 11. 1 1 . We W e do d o not n o t intend i n t e n d to t o re-issue r e - i s s u e these t h e s e draft d r a f t guidance g u i d a n c e documents d o c u m e n t s or o r the t h e CPG. C P G . We W e are a r e now n o w re-examining r e - e x a m i n i n g part p a r t 11, 1 1 , and a n d we w e anticipate a n t i c i p a t e initiating i n i t i a t i n g rulemaking r u l e m a k i n g to t o revise r e v i s e provisions p r o v i s i o n s of o f that t h a t regulation. r e g u l a t i o n . To T o avoid a v o i d unnecessary u n n e c e s s a r y resource r e s o u r c e expenditures e x p e n d i t u r e s to t o comply c o m p l y with w i t h part p a r t 11 1 1 requirements, r e q u i r e m e n t s , we w e are a r e issuing i s s u i n g this t h i s guidance g u i d a n c e to t o describe d e s c r i b e how h o w we w e intend i n t e n d to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n with w i t h regard r e g a r d to t o certain c e r t a i n part p a r t 11 1 1 requirements r e q u i r e m e n t s during d u r i n g the t h e re-examination r e - e x a m i n a t i o n of o f part p a r t 11. 1 1 . As A s mentioned m e n t i o n e d previously, p r e v i o u s l y , part p a r t 11 1 1 remains r e m a i n s in i n effect e f f e c t during d u r i n g this t h i s re-examination r e - e x a m i n a t i o n period. p e r i o d . III. I I I . DISCUSSION D I S C U S S I O N A. A . Overall O v e r a l l Approach A p p r o a c h to t o Part P a r t 11 1 1 Requirements R e q u i r e m e n t s 5 5 Although A l t h o u g h we w e withdrew w i t h d r e w the t h e draft d r a f t guidance g u i d a n c e on o n time t i m e stamps, s t a m p s , our o u r current c u r r e n t thinking t h i n k i n g has h a s not n o t changed c h a n g e d in i n that t h a t when w h e n using u s i n g time t i m e stamps s t a m p s for f o r systems s y s t e m s that t h a t span s p a n different d i f f e r e n t time t i m e zones, z o n e s , we w e do d o not n o t expect e x p e c t you y o u to t o record r e c o r d the t h e signer’s s i g n e r ’ s local l o c a l time. t i m e . When W h e n using u s i n g time t i m e stamps, s t a m p s , they t h e y should s h o u l d be b e implemented i m p l e m e n t e d with w i t h a a clear c l e a r understanding u n d e r s t a n d i n g of o f the t h e time t i m e zone z o n e reference r e f e r e n c e used. u s e d . In I n such s u c h instances, i n s t a n c e s , system s y s t e m documentation d o c u m e n t a t i o n should s h o u l d explain e x p l a i n time t i m e zone z o n e references r e f e r e n c e s as a s well w e l l as a s zone z o n e acronyms a c r o n y m s or o r other o t h e r naming n a m i n g conventions. c o n v e n t i o n s . 3 3 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 116 1 1 6 117 1 1 7 118 1 1 8 119 1 1 9 120 1 2 0 121 1 2 1 122 1 2 2 123 1 2 3 124 1 2 4 125 1 2 5 126 1 2 6 127 1 2 7 128 1 2 8 129 1 2 9 130 1 3 0 131 1 3 1 132 1 3 2 133 1 3 3 134 1 3 4 135 1 3 5 136 1 3 6 137 1 3 7 138 1 3 8 139 1 3 9 140 1 4 0 141 1 4 1 142 1 4 2 143 1 4 3 144 1 4 4 145 1 4 5 146 1 4 6 147 1 4 7 148 1 4 8 149 1 4 9 150 1 5 0 151 1 5 1 152 1 5 2 153 1 5 3 154 1 5 4 155 1 5 5 156 1 5 6 157 1 5 7 158 1 5 8 159 1 5 9 As A s described d e s c r i b e d in i n more m o r e detail d e t a i l below, b e l o w , the t h e approach a p p r o a c h outlined o u t l i n e d in i n this t h i s guidance g u i d a n c e is i s based b a s e d on o n three t h r e e main m a i n elements: e l e m e n t s : • • Part P a r t 11 1 1 will w i l l be b e interpreted i n t e r p r e t e d narrowly; n a r r o w l y ; we w e are a r e now n o w clarifying c l a r i f y i n g that t h a t fewer f e w e r records r e c o r d s will w i l l be b e considered c o n s i d e r e d subject s u b j e c t to t o part p a r t 11. 1 1 . • • For F o r those t h o s e records r e c o r d s that t h a t remain r e m a i n subject s u b j e c t to t o part p a r t 11, 1 1 , we w e intend i n t e n d to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n with w i t h regard r e g a r d to t o part p a r t 11 1 1 requirements r e q u i r e m e n t s for f o r validation, v a l i d a t i o n , audit a u d i t trails, t r a i l s , record r e c o r d retention, r e t e n t i o n , and a n d record r e c o r d copying c o p y i n g in i n the t h e manner m a n n e r described d e s c r i b e d in i n this t h i s guidance g u i d a n c e and a n d with w i t h regard r e g a r d to t o all a l l part p a r t 11 1 1 requirements r e q u i r e m e n t s for f o r systems s y s t e m s that t h a t were w e r e operational o p e r a t i o n a l before b e f o r e the t h e effective e f f e c t i v e date d a t e of o f part p a r t 11 1 1 (also ( a l s o known k n o w n as a s legacy l e g a c y systems). s y s t e m s ) . • • We W e will w i l l enforce e n f o r c e all a l l predicate p r e d i c a t e rule r u l e requirements, r e q u i r e m e n t s , including i n c l u d i n g predicate p r e d i c a t e rule r u l e record r e c o r d and a n d recordkeeping r e c o r d k e e p i n g requirements. r e q u i r e m e n t s . It I t is i s important i m p o r t a n t to t o note n o t e that t h a t FDA's F D A ' s exercise e x e r c i s e of o f enforcement e n f o r c e m e n t discretion d i s c r e t i o n as a s described d e s c r i b e d in i n this t h i s guidance g u i d a n c e is i s limited l i m i t e d to t o specified s p e c i f i e d part p a r t 11 1 1 requirements r e q u i r e m e n t s (setting ( s e t t i n g aside a s i d e legacy l e g a c y systems, s y s t e m s , as a s to t o which w h i c h the t h e extent e x t e n t of o f enforcement e n f o r c e m e n t discretion, d i s c r e t i o n , under u n d e r certain c e r t a i n circumstances, c i r c u m s t a n c e s , will w i l l be b e more m o r e broad). b r o a d ) . We W e intend i n t e n d to t o enforce e n f o r c e all a l l other o t h e r provisions p r o v i s i o n s of o f part p a r t 11 1 1 including, i n c l u d i n g , but b u t not n o t limited l i m i t e d to, t o , certain c e r t a i n controls c o n t r o l s for f o r closed c l o s e d systems s y s t e m s in i n § § 11.10. 1 1 . 1 0 . For F o r example, e x a m p l e , we w e intend i n t e n d to t o enforce e n f o r c e provisions p r o v i s i o n s related r e l a t e d to t o the t h e following f o l l o w i n g controls c o n t r o l s and a n d requirements: r e q u i r e m e n t s : • • limiting l i m i t i n g system s y s t e m access a c c e s s to t o authorized a u t h o r i z e d individuals i n d i v i d u a l s • • use u s e of o f operational o p e r a t i o n a l system s y s t e m checks c h e c k s • • use u s e of o f authority a u t h o r i t y checks c h e c k s • • use u s e of o f device d e v i c e checks c h e c k s • • determination d e t e r m i n a t i o n that t h a t persons p e r s o n s who w h o develop, d e v e l o p , maintain, m a i n t a i n , or o r use u s e electronic e l e c t r o n i c systems s y s t e m s have h a v e the t h e education, e d u c a t i o n , training, t r a i n i n g , and a n d experience e x p e r i e n c e to t o perform p e r f o r m their t h e i r assigned a s s i g n e d tasks t a s k s • • establishment e s t a b l i s h m e n t of o f and a n d adherence a d h e r e n c e to t o written w r i t t e n policies p o l i c i e s that t h a t hold h o l d individuals i n d i v i d u a l s accountable a c c o u n t a b l e for f o r actions a c t i o n s initiated i n i t i a t e d under u n d e r their t h e i r electronic e l e c t r o n i c signatures s i g n a t u r e s • • appropriate a p p r o p r i a t e controls c o n t r o l s over o v e r systems s y s t e m s documentation d o c u m e n t a t i o n • • controls c o n t r o l s for f o r open o p e n systems s y s t e m s corresponding c o r r e s p o n d i n g to t o controls c o n t r o l s for f o r closed c l o s e d systems s y s t e m s bulleted b u l l e t e d above a b o v e (§ ( § 11.30) 1 1 . 3 0 ) • • requirements r e q u i r e m e n t s related r e l a t e d to t o electronic e l e c t r o n i c signatures s i g n a t u r e s (e.g., ( e . g . , §§ § § 11.50, 1 1 . 5 0 , 11.70, 1 1 . 7 0 , 11.100, 1 1 . 1 0 0 , 11.200, 1 1 . 2 0 0 , and a n d 11.300) 1 1 . 3 0 0 ) We W e expect e x p e c t continued c o n t i n u e d compliance c o m p l i a n c e with w i t h these t h e s e provisions, p r o v i s i o n s , and a n d we w e will w i l l continue c o n t i n u e to t o enforce e n f o r c e them. t h e m . Furthermore, F u r t h e r m o r e , persons p e r s o n s must m u s t comply c o m p l y with w i t h applicable a p p l i c a b l e predicate p r e d i c a t e rules, r u l e s , and a n d records r e c o r d s that t h a t are a r e required r e q u i r e d to t o be b e maintained m a i n t a i n e d or o r submitted s u b m i t t e d must m u s t remain r e m a i n secure s e c u r e and a n d reliable r e l i a b l e in i n accordance a c c o r d a n c e with w i t h the t h e predicate p r e d i c a t e rules. r u l e s . B. B . Details D e t a i l s of o f Approach A p p r o a c h – – Scope S c o p e of o f Part P a r t 11 1 1 1. 1 . Narrow N a r r o w Interpretation I n t e r p r e t a t i o n of o f Scope S c o p e We W e understand u n d e r s t a n d that t h a t there t h e r e is i s some s o m e confusion c o n f u s i o n about a b o u t the t h e scope s c o p e of o f part p a r t 11. 1 1 . Some S o m e have h a v e understood u n d e r s t o o d the t h e scope s c o p e of o f part p a r t 11 1 1 to t o be b e very v e r y broad. b r o a d . We W e believe b e l i e v e that t h a t some s o m e of o f those t h o s e broad b r o a d interpretations i n t e r p r e t a t i o n s could c o u l d 4 4 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 160 1 6 0 161 1 6 1 162 1 6 2 163 1 6 3 164 1 6 4 165 1 6 5 166 1 6 6 167 1 6 7 168 1 6 8 169 1 6 9 170 1 7 0 171 1 7 1 172 1 7 2 173 1 7 3 174 1 7 4 175 1 7 5 176 1 7 6 177 1 7 7 178 1 7 8 179 1 7 9 180 1 8 0 181 1 8 1 182 1 8 2 183 1 8 3 184 1 8 4 185 1 8 5 186 1 8 6 187 1 8 7 188 1 8 8 189 1 8 9 190 1 9 0 191 1 9 1 192 1 9 2 193 1 9 3 194 1 9 4 195 1 9 5 196 1 9 6 197 1 9 7 198 1 9 8 199 1 9 9 200 2 0 0 201 2 0 1 202 2 0 2 203 2 0 3 lead l e a d to t o unnecessary u n n e c e s s a r y controls c o n t r o l s and a n d costs c o s t s and a n d could c o u l d discourage d i s c o u r a g e innovation i n n o v a t i o n and a n d technological t e c h n o l o g i c a l advances a d v a n c e s without w i t h o u t providing p r o v i d i n g added a d d e d benefit b e n e f i t to t o the t h e public p u b l i c health. h e a l t h . As A s a a result, r e s u l t , we w e want w a n t to t o clarify c l a r i f y that t h a t the t h e Agency A g e n c y intends i n t e n d s to t o interpret i n t e r p r e t the t h e scope s c o p e of o f part p a r t 11 1 1 narrowly. n a r r o w l y . Under U n d e r the t h e narrow n a r r o w interpretation i n t e r p r e t a t i o n of o f the t h e scope s c o p e of o f part p a r t 11, 1 1 , with w i t h respect r e s p e c t to t o records r e c o r d s required r e q u i r e d to t o be b e maintained m a i n t a i n e d under u n d e r predicate p r e d i c a t e rules r u l e s or o r submitted s u b m i t t e d to t o FDA, F D A , when w h e n persons p e r s o n s choose c h o o s e to t o use u s e records r e c o r d s in i n electronic e l e c t r o n i c format f o r m a t in i n place p l a c e of o f paper p a p e r format, f o r m a t , part p a r t 11 1 1 would w o u l d apply. a p p l y . On O n the t h e other o t h e r hand, h a n d , when w h e n persons p e r s o n s use u s e computers c o m p u t e r s to t o generate g e n e r a t e paper p a p e r printouts p r i n t o u t s of o f electronic e l e c t r o n i c records, r e c o r d s , and a n d those t h o s e paper p a p e r records r e c o r d s meet m e e t all a l l the t h e requirements r e q u i r e m e n t s of o f the t h e applicable a p p l i c a b l e predicate p r e d i c a t e rules r u l e s and a n d persons p e r s o n s rely r e l y on o n the t h e paper p a p e r records r e c o r d s to t o perform p e r f o r m their t h e i r regulated r e g u l a t e d activities, a c t i v i t i e s , FDA F D A would w o u l d generally g e n e r a l l y not n o t consider c o n s i d e r persons p e r s o n s to t o be b e "using " u s i n g electronic e l e c t r o n i c records r e c o r d s in i n lieu l i e u of o f paper p a p e r records" r e c o r d s " under u n d e r §§ § § 11.2(a) 1 1 . 2 ( a ) and a n d 11.2(b). 1 1 . 2 ( b ) . In I n these t h e s e instances, i n s t a n c e s , the t h e use u s e of o f computer c o m p u t e r systems s y s t e m s in i n the t h e generation g e n e r a t i o n of o f paper p a p e r records r e c o r d s would w o u l d not n o t trigger t r i g g e r part p a r t 11. 1 1 . 2. 2 . Definition D e f i n i t i o n of o f Part P a r t 11 1 1 Records R e c o r d s Under U n d e r this t h i s narrow n a r r o w interpretation, i n t e r p r e t a t i o n , FDA F D A considers c o n s i d e r s part p a r t 11 1 1 to t o be b e applicable a p p l i c a b l e to t o the t h e following f o l l o w i n g records r e c o r d s or o r signatures s i g n a t u r e s in i n electronic e l e c t r o n i c format f o r m a t (part ( p a r t 11 1 1 records r e c o r d s or o r signatures): s i g n a t u r e s ) : • • Records R e c o r d s that t h a t are a r e required r e q u i r e d to t o be b e maintained m a i n t a i n e d under u n d e r predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s and a n d that t h a t are a r e maintained m a i n t a i n e d in i n electronic e l e c t r o n i c format f o r m a t in i n place p l a c e of o f paper p a p e r format. f o r m a t . On O n the t h e other o t h e r hand, h a n d , records r e c o r d s (and ( a n d any a n y associated a s s o c i a t e d signatures) s i g n a t u r e s ) that t h a t are a r e not n o t required r e q u i r e d to t o be b e retained r e t a i n e d under u n d e r predicate p r e d i c a t e rules, r u l e s , but b u t that t h a t are a r e nonetheless n o n e t h e l e s s maintained m a i n t a i n e d in i n electronic e l e c t r o n i c format, f o r m a t , are a r e not n o t part p a r t 11 1 1 records. r e c o r d s . We W e recommend r e c o m m e n d that t h a t you y o u determine, d e t e r m i n e , based b a s e d on o n the t h e predicate p r e d i c a t e rules, r u l e s , whether w h e t h e r specific s p e c i f i c records r e c o r d s are a r e part p a r t 11 1 1 records. r e c o r d s . We W e recommend r e c o m m e n d that t h a t you y o u document d o c u m e n t such s u c h decisions. d e c i s i o n s . • • Records R e c o r d s that t h a t are a r e required r e q u i r e d to t o be b e maintained m a i n t a i n e d under u n d e r predicate p r e d i c a t e rules, r u l e s , that t h a t are a r e maintained m a i n t a i n e d in i n electronic e l e c t r o n i c format f o r m a t in i n addition a d d i t i o n to t o paper p a p e r format, f o r m a t , and a n d that t h a t are a r e relied r e l i e d on o n to t o perform p e r f o r m regulated r e g u l a t e d activities. a c t i v i t i e s . In I n some s o m e cases, c a s e s , actual a c t u a l business b u s i n e s s practices p r a c t i c e s may m a y dictate d i c t a t e whether w h e t h e r you y o u are a r e using u s i n g electronic e l e c t r o n i c records r e c o r d s instead i n s t e a d of o f paper p a p e r records r e c o r d s under u n d e r § § 11.2(a). 1 1 . 2 ( a ) . For F o r example, e x a m p l e , if i f a a record r e c o r d is i s required r e q u i r e d to t o be b e maintained m a i n t a i n e d under u n d e r a a predicate p r e d i c a t e rule r u l e and a n d you y o u use u s e a a computer c o m p u t e r to t o generate g e n e r a t e a a paper p a p e r printout p r i n t o u t of o f the t h e electronic e l e c t r o n i c records, r e c o r d s , but b u t you y o u nonetheless n o n e t h e l e s s rely r e l y on o n the t h e electronic e l e c t r o n i c record r e c o r d to t o perform p e r f o r m regulated r e g u l a t e d activities, a c t i v i t i e s , the t h e Agency A g e n c y may m a y consider c o n s i d e r you y o u to t o be b e using u s i n g the t h e electronic e l e c t r o n i c record r e c o r d instead i n s t e a d of o f the t h e paper p a p e r record. r e c o r d . That T h a t is, i s , the t h e Agency A g e n c y may m a y take t a k e your y o u r business b u s i n e s s practices p r a c t i c e s into i n t o account a c c o u n t in i n determining d e t e r m i n i n g whether w h e t h e r part p a r t 11 1 1 applies. a p p l i e s . Accordingly, A c c o r d i n g l y , we w e recommend r e c o m m e n d that, t h a t , for f o r each e a c h record r e c o r d required r e q u i r e d to t o be b e maintained m a i n t a i n e d under u n d e r predicate p r e d i c a t e rules, r u l e s , you y o u determine d e t e r m i n e in i n advance a d v a n c e whether w h e t h e r you y o u plan p l a n to t o rely r e l y on o n the t h e electronic e l e c t r o n i c record r e c o r d or o r paper p a p e r record r e c o r d to t o perform p e r f o r m regulated r e g u l a t e d activities. a c t i v i t i e s . We W e recommend r e c o m m e n d that t h a t you y o u document d o c u m e n t this t h i s decision d e c i s i o n (e.g., ( e . g . , in i n a a Standard S t a n d a r d Operating O p e r a t i n g Procedure P r o c e d u r e (SOP), ( S O P ) , or o r specification s p e c i f i c a t i o n document). d o c u m e n t ) . • • Records R e c o r d s submitted s u b m i t t e d to t o FDA, F D A , under u n d e r predicate p r e d i c a t e rules r u l e s (even ( e v e n if i f such s u c h records r e c o r d s are a r e not n o t specifically s p e c i f i c a l l y identified i d e n t i f i e d in i n Agency A g e n c y regulations) r e g u l a t i o n s ) in i n electronic e l e c t r o n i c format f o r m a t (assuming ( a s s u m i n g the t h e records r e c o r d s have h a v e been b e e n identified i d e n t i f i e d in i n docket d o c k e t number n u m b e r 92S-0251 9 2 S - 0 2 5 1 as a s the t h e types t y p e s of o f submissions s u b m i s s i o n s the t h e Agency A g e n c y accepts a c c e p t s in i n electronic e l e c t r o n i c format). f o r m a t ) . However, H o w e v e r , a a record r e c o r d that t h a t is i s not n o t itself i t s e l f submitted, s u b m i t t e d , but b u t is i s used u s e d 5 5 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 204 2 0 4 205 2 0 5 206 2 0 6 207 2 0 7 208 2 0 8 209 2 0 9 210 2 1 0 211 2 1 1 212 2 1 2 213 2 1 3 214 2 1 4 215 2 1 5 216 2 1 6 217 2 1 7 218 2 1 8 219 2 1 9 220 2 2 0 221 2 2 1 222 2 2 2 223 2 2 3 224 2 2 4 225 2 2 5 226 2 2 6 227 2 2 7 228 2 2 8 229 2 2 9 230 2 3 0 231 2 3 1 232 2 3 2 233 2 3 3 234 2 3 4 235 2 3 5 236 2 3 6 237 2 3 7 238 2 3 8 239 2 3 9 240 2 4 0 241 2 4 1 242 2 4 2 243 2 4 3 244 2 4 4 245 2 4 5 246 2 4 6 247 2 4 7 248 2 4 8 249 2 4 9 in i n generating g e n e r a t i n g a a submission, s u b m i s s i o n , is i s not n o t a a part p a r t 11 1 1 record r e c o r d unless u n l e s s it i t is i s otherwise o t h e r w i s e required r e q u i r e d to t o be b e maintained m a i n t a i n e d under u n d e r a a predicate p r e d i c a t e rule r u l e and a n d it i t is i s maintained m a i n t a i n e d in i n electronic e l e c t r o n i c format. f o r m a t . • • Electronic E l e c t r o n i c signatures s i g n a t u r e s that t h a t are a r e intended i n t e n d e d to t o be b e the t h e equivalent e q u i v a l e n t of o f handwritten h a n d w r i t t e n signatures, s i g n a t u r e s , initials, i n i t i a l s , and a n d other o t h e r general g e n e r a l signings s i g n i n g s required r e q u i r e d by b y predicate p r e d i c a t e rules. r u l e s . Part P a r t 11 1 1 signatures s i g n a t u r e s include i n c l u d e electronic e l e c t r o n i c signatures s i g n a t u r e s that t h a t are a r e used, u s e d , for f o r example, e x a m p l e , to t o document d o c u m e n t the t h e fact f a c t that t h a t certain c e r t a i n events e v e n t s or o r actions a c t i o n s occurred o c c u r r e d in i n accordance a c c o r d a n c e with w i t h the t h e predicate p r e d i c a t e rule r u l e (e.g. ( e . g . approved, a p p r o v e d , reviewed, r e v i e w e d , and a n d verified). v e r i f i e d ) . C. C . Approach A p p r o a c h to t o Specific S p e c i f i c Part P a r t 11 1 1 Requirements R e q u i r e m e n t s 1. 1 . Validation V a l i d a t i o n The T h e Agency A g e n c y intends i n t e n d s to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n regarding r e g a r d i n g specific s p e c i f i c part p a r t 11 1 1 requirements r e q u i r e m e n t s for f o r validation v a l i d a t i o n of o f computerized c o m p u t e r i z e d systems s y s t e m s (§ ( § 11.10(a) 1 1 . 1 0 ( a ) and a n d corresponding c o r r e s p o n d i n g requirements r e q u i r e m e n t s in i n § § 11.30). 1 1 . 3 0 ) . Although A l t h o u g h persons p e r s o n s must m u s t still s t i l l comply c o m p l y with w i t h all a l l applicable a p p l i c a b l e predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s for f o r validation v a l i d a t i o n (e.g., ( e . g . , 21 2 1 CFR C F R 820.70(i)), 8 2 0 . 7 0 ( i ) ) , this t h i s guidance g u i d a n c e should s h o u l d not n o t be b e read r e a d to t o impose i m p o s e any a n y additional a d d i t i o n a l requirements r e q u i r e m e n t s for f o r validation. v a l i d a t i o n . We W e suggest s u g g e s t that t h a t your y o u r decision d e c i s i o n to t o validate v a l i d a t e computerized c o m p u t e r i z e d systems, s y s t e m s , and a n d the t h e extent e x t e n t of o f the t h e validation, v a l i d a t i o n , take t a k e into i n t o account a c c o u n t the t h e impact i m p a c t the t h e systems s y s t e m s have h a v e on o n your y o u r ability a b i l i t y to t o meet m e e t predicate p r e d i c a t e rule r u l e requirements. r e q u i r e m e n t s . You Y o u should s h o u l d also a l s o consider c o n s i d e r the t h e impact i m p a c t those t h o s e systems s y s t e m s might m i g h t have h a v e on o n the t h e accuracy, a c c u r a c y , reliability, r e l i a b i l i t y , integrity, i n t e g r i t y , availability, a v a i l a b i l i t y , and a n d authenticity a u t h e n t i c i t y of o f required r e q u i r e d records r e c o r d s and a n d signatures. s i g n a t u r e s . Even E v e n if i f there t h e r e is i s no n o predicate p r e d i c a t e rule r u l e requirement r e q u i r e m e n t to t o validate v a l i d a t e a a system, s y s t e m , in i n some s o m e instances i n s t a n c e s it i t may m a y still s t i l l be b e important i m p o r t a n t to t o validate v a l i d a t e the t h e system. s y s t e m . We W e recommend r e c o m m e n d that t h a t you y o u base b a s e your y o u r approach a p p r o a c h on o n a a justified j u s t i f i e d and a n d documented d o c u m e n t e d risk r i s k assessment a s s e s s m e n t and a n d a a determination d e t e r m i n a t i o n of o f the t h e potential p o t e n t i a l of o f the t h e system s y s t e m to t o affect a f f e c t product p r o d u c t quality q u a l i t y and a n d safety, s a f e t y , and a n d record r e c o r d integrity. i n t e g r i t y . For F o r instance, i n s t a n c e , validation v a l i d a t i o n would w o u l d not n o t be b e important i m p o r t a n t for f o r a a word w o r d processor p r o c e s s o r used u s e d only o n l y to t o generate g e n e r a t e SOPs. S O P s . For F o r further f u r t h e r guidance g u i d a n c e on o n validation v a l i d a t i o n of o f computerized c o m p u t e r i z e d systems, s y s t e m s , see s e e FDA’s F D A ’ s guidance g u i d a n c e for f o r industry i n d u s t r y and a n d FDA F D A staff s t a f f General G e n e r a l Principles P r i n c i p l e s of o f Software S o f t w a r e Validation V a l i d a t i o n and a n d also a l s o industry i n d u s t r y guidance g u i d a n c e such s u c h as a s the t h e GAMP G A M P 4 4 Guide G u i d e (See ( S e e References). R e f e r e n c e s ) . 2. 2 . Audit A u d i t Trail T r a i l The T h e Agency A g e n c y intends i n t e n d s to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n regarding r e g a r d i n g specific s p e c i f i c part p a r t 11 1 1 requirements r e q u i r e m e n t s related r e l a t e d to t o computer-generated, c o m p u t e r - g e n e r a t e d , time-stamped t i m e - s t a m p e d audit a u d i t trails t r a i l s (§ ( § 11.10 1 1 . 1 0 (e), ( e ) , (k)(2) ( k ) ( 2 ) and a n d any a n y corresponding c o r r e s p o n d i n g requirement r e q u i r e m e n t in i n §11.30). § 1 1 . 3 0 ) . Persons P e r s o n s must m u s t still s t i l l comply c o m p l y with w i t h all a l l applicable a p p l i c a b l e predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s related r e l a t e d to t o documentation d o c u m e n t a t i o n of, o f , for f o r example, e x a m p l e , date d a t e (e.g., ( e . g . , § § 58.130(e)), 5 8 . 1 3 0 ( e ) ) , time, t i m e , or o r sequencing s e q u e n c i n g of o f events, e v e n t s , as a s well w e l l as a s any a n y requirements r e q u i r e m e n t s for f o r ensuring e n s u r i n g that t h a t changes c h a n g e s to t o records r e c o r d s do d o not n o t obscure o b s c u r e previous p r e v i o u s entries. e n t r i e s . Even E v e n if i f there t h e r e are a r e no n o predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s to t o document, d o c u m e n t , for f o r example, e x a m p l e , date, d a t e , time, t i m e , or o r sequence s e q u e n c e of o f events e v e n t s in i n a a particular p a r t i c u l a r instance, i n s t a n c e , it i t may m a y nonetheless n o n e t h e l e s s be b e important i m p o r t a n t to t o have h a v e audit a u d i t trails t r a i l s or o r other o t h e r physical, p h y s i c a l , logical, l o g i c a l , or o r procedural p r o c e d u r a l security s e c u r i t y measures m e a s u r e s in i n place p l a c e to t o ensure e n s u r e the t h e trustworthiness t r u s t w o r t h i n e s s and a n d 6 6 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 250 2 5 0 251 2 5 1 252 2 5 2 253 2 5 3 254 2 5 4 255 2 5 5 256 2 5 6 257 2 5 7 258 2 5 8 259 2 5 9 260 2 6 0 261 2 6 1 262 2 6 2 263 2 6 3 264 2 6 4 265 2 6 5 266 2 6 6 267 2 6 7 268 2 6 8 269 2 6 9 270 2 7 0 271 2 7 1 272 2 7 2 273 2 7 3 274 2 7 4 275 2 7 5 276 2 7 6 277 2 7 7 278 2 7 8 279 2 7 9 280 2 8 0 281 2 8 1 282 2 8 2 283 2 8 3 284 2 8 4 285 2 8 5 286 2 8 6 287 2 8 7 288 2 8 8 289 2 8 9 290 2 9 0 reliability r e l i a b i l i t y of o f the t h e records. r e c o r d s . 6 6 We W e recommend r e c o m m e n d that t h a t you y o u base b a s e your y o u r decision d e c i s i o n on o n whether w h e t h e r to t o apply a p p l y audit a u d i t trails, t r a i l s , or o r other o t h e r appropriate a p p r o p r i a t e measures, m e a s u r e s , on o n the t h e need n e e d to t o comply c o m p l y with w i t h predicate p r e d i c a t e rule r u l e requirements, r e q u i r e m e n t s , a a justified j u s t i f i e d and a n d documented d o c u m e n t e d risk r i s k assessment, a s s e s s m e n t , and a n d a a determination d e t e r m i n a t i o n of o f the t h e potential p o t e n t i a l effect e f f e c t on o n product p r o d u c t quality q u a l i t y and a n d safety s a f e t y and a n d record r e c o r d integrity. i n t e g r i t y . We W e suggest s u g g e s t that t h a t you y o u apply a p p l y appropriate a p p r o p r i a t e controls c o n t r o l s based b a s e d on o n such s u c h an a n assessment. a s s e s s m e n t . Audit A u d i t trails t r a i l s can c a n be b e particularly p a r t i c u l a r l y appropriate a p p r o p r i a t e when w h e n users u s e r s are a r e expected e x p e c t e d to t o create, c r e a t e , modify, m o d i f y , or o r delete d e l e t e regulated r e g u l a t e d records r e c o r d s during d u r i n g normal n o r m a l operation. o p e r a t i o n . 3. 3 . Legacy L e g a c y Systems S y s t e m s 7 7 The T h e Agency A g e n c y intends i n t e n d s to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n with w i t h respect r e s p e c t to t o all a l l part p a r t 11 1 1 requirements r e q u i r e m e n t s for f o r systems s y s t e m s that t h a t otherwise o t h e r w i s e were w e r e operational o p e r a t i o n a l prior p r i o r to t o August A u g u s t 20, 2 0 , 1997, 1 9 9 7 , the t h e effective e f f e c t i v e date d a t e of o f part p a r t 11, 1 1 , under u n d e r the t h e circumstances c i r c u m s t a n c e s specified s p e c i f i e d below. b e l o w . This T h i s means m e a n s that t h a t the t h e Agency A g e n c y does d o e s not n o t intend i n t e n d to t o take t a k e enforcement e n f o r c e m e n t action a c t i o n to t o enforce e n f o r c e compliance c o m p l i a n c e with w i t h any a n y part p a r t 11 1 1 requirements r e q u i r e m e n t s if i f all a l l the t h e following f o l l o w i n g criteria c r i t e r i a are a r e met m e t for f o r a a specific s p e c i f i c system: s y s t e m : • • The T h e system s y s t e m was w a s operational o p e r a t i o n a l before b e f o r e the t h e effective e f f e c t i v e date. d a t e . • • The T h e system s y s t e m met m e t all a l l applicable a p p l i c a b l e predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s before b e f o r e the t h e effective e f f e c t i v e date. d a t e . • • The T h e system s y s t e m currently c u r r e n t l y meets m e e t s all a l l applicable a p p l i c a b l e predicate p r e d i c a t e rule r u l e requirements. r e q u i r e m e n t s . • • You Y o u have h a v e documented d o c u m e n t e d evidence e v i d e n c e and a n d justification j u s t i f i c a t i o n that t h a t the t h e system s y s t e m is i s fit f i t for f o r its i t s intended i n t e n d e d use u s e (including ( i n c l u d i n g having h a v i n g an a n acceptable a c c e p t a b l e level l e v e l of o f record r e c o r d security s e c u r i t y and a n d integrity, i n t e g r i t y , if i f applicable). a p p l i c a b l e ) . If I f a a system s y s t e m has h a s been b e e n changed c h a n g e d since s i n c e August A u g u s t 20, 2 0 , 1997, 1 9 9 7 , and a n d if i f the t h e changes c h a n g e s would w o u l d prevent p r e v e n t the t h e system s y s t e m from f r o m meeting m e e t i n g predicate p r e d i c a t e rule r u l e requirements, r e q u i r e m e n t s , Part P a r t 11 1 1 controls c o n t r o l s should s h o u l d be b e applied a p p l i e d to t o Part P a r t 11 1 1 records r e c o r d s and a n d signatures s i g n a t u r e s pursuant p u r s u a n t to t o the t h e enforcement e n f o r c e m e n t policy p o l i c y expressed e x p r e s s e d in i n this t h i s guidance. g u i d a n c e . 4. 4 . Copies C o p i e s of o f Records R e c o r d s The T h e Agency A g e n c y intends i n t e n d s to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n with w i t h regard r e g a r d to t o specific s p e c i f i c part p a r t 11 1 1 requirements r e q u i r e m e n t s for f o r generating g e n e r a t i n g copies c o p i e s of o f records r e c o r d s (§ ( § 11.10 1 1 . 1 0 (b) ( b ) and a n d any a n y corresponding c o r r e s p o n d i n g requirement r e q u i r e m e n t in i n §11.30). § 1 1 . 3 0 ) . You Y o u should s h o u l d provide p r o v i d e an a n investigator i n v e s t i g a t o r with w i t h reasonable r e a s o n a b l e and a n d useful u s e f u l access a c c e s s to t o records r e c o r d s during d u r i n g an a n inspection. i n s p e c t i o n . All A l l records r e c o r d s held h e l d by b y you y o u are a r e subject s u b j e c t to t o inspection i n s p e c t i o n in i n accordance a c c o r d a n c e with w i t h predicate p r e d i c a t e rules r u l e s (e.g., ( e . g . , §§ § § 211.180(c), 2 1 1 . 1 8 0 ( c ) , (d), ( d ) , and a n d 108.35(c)(3)(ii)). 1 0 8 . 3 5 ( c ) ( 3 ) ( i i ) ) . We W e recommend r e c o m m e n d that t h a t you y o u supply s u p p l y copies c o p i e s of o f electronic e l e c t r o n i c records r e c o r d s by: b y : • • Producing P r o d u c i n g copies c o p i e s of o f records r e c o r d s held h e l d in i n common c o m m o n portable p o r t a b l e formats f o r m a t s when w h e n records r e c o r d s are a r e maintained m a i n t a i n e d in i n these t h e s e formats f o r m a t s • • Using U s i n g established e s t a b l i s h e d automated a u t o m a t e d conversion c o n v e r s i o n or o r export e x p o r t methods, m e t h o d s , where w h e r e available, a v a i l a b l e , to t o make m a k e copies c o p i e s in i n a a more m o r e common c o m m o n format f o r m a t (examples ( e x a m p l e s of o f such s u c h formats f o r m a t s include, i n c l u d e , but b u t are a r e not n o t limited l i m i t e d to, t o , PDF, P D F , XML, X M L , or o r SGML) S G M L ) 6 6 Various V a r i o u s guidance g u i d a n c e documents d o c u m e n t s on o n information i n f o r m a t i o n security s e c u r i t y are a r e available a v a i l a b l e (see ( s e e References). R e f e r e n c e s ) . 7 7 In I n this t h i s guidance g u i d a n c e document, d o c u m e n t , we w e use u s e the t h e term t e r m legacy l e g a c y system s y s t e m to t o describe d e s c r i b e systems s y s t e m s already a l r e a d y in i n operation o p e r a t i o n before b e f o r e the t h e effective e f f e c t i v e date d a t e of o f part p a r t 11. 1 1 . 7 7 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 291 2 9 1 292 2 9 2 293 2 9 3 294 2 9 4 295 2 9 5 296 2 9 6 297 2 9 7 298 2 9 8 299 2 9 9 300 3 0 0 301 3 0 1 302 3 0 2 303 3 0 3 304 3 0 4 305 3 0 5 306 3 0 6 307 3 0 7 308 3 0 8 309 3 0 9 310 3 1 0 311 3 1 1 312 3 1 2 313 3 1 3 314 3 1 4 315 3 1 5 316 3 1 6 317 3 1 7 318 3 1 8 319 3 1 9 In I n each e a c h case, c a s e , we w e recommend r e c o m m e n d that t h a t the t h e copying c o p y i n g process p r o c e s s used u s e d produces p r o d u c e s copies c o p i e s that t h a t preserve p r e s e r v e the t h e content c o n t e n t and a n d meaning m e a n i n g of o f the t h e record. r e c o r d . If I f you y o u have h a v e the t h e ability a b i l i t y to t o search, s e a r c h , sort, s o r t , or o r trend t r e n d part p a r t 11 1 1 records, r e c o r d s , copies c o p i e s given g i v e n to t o the t h e Agency A g e n c y should s h o u l d provide p r o v i d e the t h e same s a m e capability c a p a b i l i t y if i f it i t is i s reasonable r e a s o n a b l e and a n d technically t e c h n i c a l l y feasible. f e a s i b l e . You Y o u should s h o u l d allow a l l o w inspection, i n s p e c t i o n , review, r e v i e w , and a n d copying c o p y i n g of o f records r e c o r d s in i n a a human h u m a n readable r e a d a b l e form f o r m at a t your y o u r site s i t e using u s i n g your y o u r hardware h a r d w a r e and a n d following f o l l o w i n g your y o u r established e s t a b l i s h e d procedures p r o c e d u r e s and a n d techniques t e c h n i q u e s for f o r accessing a c c e s s i n g records. r e c o r d s . 5. 5 . Record R e c o r d Retention R e t e n t i o n The T h e Agency A g e n c y intends i n t e n d s to t o exercise e x e r c i s e enforcement e n f o r c e m e n t discretion d i s c r e t i o n with w i t h regard r e g a r d to t o the t h e part p a r t 11 1 1 requirements r e q u i r e m e n t s for f o r the t h e protection p r o t e c t i o n of o f records r e c o r d s to t o enable e n a b l e their t h e i r accurate a c c u r a t e and a n d ready r e a d y retrieval r e t r i e v a l throughout t h r o u g h o u t the t h e records r e c o r d s retention r e t e n t i o n period p e r i o d (§ ( § 11.10 1 1 . 1 0 (c) ( c ) and a n d any a n y corresponding c o r r e s p o n d i n g requirement r e q u i r e m e n t in i n §11.30). § 1 1 . 3 0 ) . Persons P e r s o n s must m u s t still s t i l l comply c o m p l y with w i t h all a l l applicable a p p l i c a b l e predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s for f o r record r e c o r d retention r e t e n t i o n and a n d availability a v a i l a b i l i t y (e.g., ( e . g . , §§ § § 211.180(c),(d), 2 1 1 . 1 8 0 ( c ) , ( d ) , 108.25(g), 1 0 8 . 2 5 ( g ) , and a n d 108.35(h)). 1 0 8 . 3 5 ( h ) ) . We W e suggest s u g g e s t that t h a t your y o u r decision d e c i s i o n on o n how h o w to t o maintain m a i n t a i n records r e c o r d s be b e based b a s e d on o n predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s and a n d that t h a t you y o u base b a s e your y o u r decision d e c i s i o n on o n a a justified j u s t i f i e d and a n d documented d o c u m e n t e d risk r i s k assessment a s s e s s m e n t and a n d a a determination d e t e r m i n a t i o n of o f the t h e value v a l u e of o f the t h e records r e c o r d s over o v e r time. t i m e . FDA F D A does d o e s not n o t intend i n t e n d to t o object o b j e c t if i f you y o u decide d e c i d e to t o archive a r c h i v e required r e q u i r e d records r e c o r d s in i n electronic e l e c t r o n i c format f o r m a t to t o nonelectronic n o n e l e c t r o n i c media m e d i a such s u c h as a s microfilm, m i c r o f i l m , microfiche, m i c r o f i c h e , and a n d paper, p a p e r , or o r to t o a a standard s t a n d a r d electronic e l e c t r o n i c file f i l e format f o r m a t (examples ( e x a m p l e s of o f such s u c h formats f o r m a t s include, i n c l u d e , but b u t are a r e not n o t limited l i m i t e d to, t o , PDF, P D F , XML, X M L , or o r SGML). S G M L ) . Persons P e r s o n s must m u s t still s t i l l comply c o m p l y with w i t h all a l l predicate p r e d i c a t e rule r u l e requirements, r e q u i r e m e n t s , and a n d the t h e records r e c o r d s themselves t h e m s e l v e s and a n d any a n y copies c o p i e s of o f the t h e required r e q u i r e d records r e c o r d s should s h o u l d preserve p r e s e r v e their t h e i r content c o n t e n t and a n d meaning. m e a n i n g . As A s long l o n g as a s predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s are a r e fully f u l l y satisfied s a t i s f i e d and a n d the t h e content c o n t e n t and a n d meaning m e a n i n g of o f the t h e records r e c o r d s are a r e preserved p r e s e r v e d and a n d archived, a r c h i v e d , you y o u can c a n delete d e l e t e the t h e electronic e l e c t r o n i c version v e r s i o n of o f the t h e records. r e c o r d s . In I n addition, a d d i t i o n , paper p a p e r and a n d electronic e l e c t r o n i c record r e c o r d and a n d signature s i g n a t u r e components c o m p o n e n t s can c a n co-exist c o - e x i s t (i.e., ( i . e . , a a hybrid h y b r i d 8 8 situation) s i t u a t i o n ) as a s long l o n g as a s predicate p r e d i c a t e rule r u l e requirements r e q u i r e m e n t s are a r e met m e t and a n d the t h e content c o n t e n t and a n d meaning m e a n i n g of o f those t h o s e records r e c o r d s are a r e preserved. p r e s e r v e d . 8 8 Examples E x a m p l e s of o f hybrid h y b r i d situations s i t u a t i o n s include i n c l u d e combinations c o m b i n a t i o n s of o f paper p a p e r records r e c o r d s (or ( o r other o t h e r nonelectronic n o n e l e c t r o n i c media) m e d i a ) and a n d electronic e l e c t r o n i c records, r e c o r d s , paper p a p e r records r e c o r d s and a n d electronic e l e c t r o n i c signatures, s i g n a t u r e s , or o r handwritten h a n d w r i t t e n signatures s i g n a t u r e s executed e x e c u t e d to t o electronic e l e c t r o n i c records. r e c o r d s . 8 8 granularity=word tetml={elements={line} glyphdetails={all}} contentanalysis={punctuationbreaks=false dehyphenate=false shadowdetect=false} layoutanalysis={tabledetect=0 layoutdetect=3} structureanalysis={list=true} Contains C o n t a i n s Nonbinding N o n b i n d i n g Recommendations R e c o m m e n d a t i o n s 319 3 1 9 320 3 2 0 321 3 2 1 322 3 2 2 323 3 2 3 324 3 2 4 325 3 2 5 326 3 2 6 327 3 2 7 328 3 2 8 329 3 2 9 330 3 3 0 331 3 3 1 332 3 3 2 333 3 3 3 334 3 3 4 335 3 3 5 336 3 3 6 337 3 3 7 338 3 3 8 339 3 3 9 340 3 4 0 341 3 4 1 342 3 4 2 343 3 4 3 344 3 4 4 345 3 4 5 346 3 4 6 347 3 4 7 348 3 4 8 349 3 4 9 350 3 5 0 351 3 5 1 352 3 5 2 IV. I V . REFERENCES R E F E R E N C E S Food F o o d and a n d Drug D r u g Administration A d m i n i s t r a t i o n References R e f e r e n c e s 1. 1 . Glossary G l o s s a r y of o f Computerized C o m p u t e r i z e d System S y s t e m and a n d Software S o f t w a r e Development D e v e l o p m e n t Terminology T e r m i n o l o g y (Division ( D i v i s i o n of o f Field F i e l d Investigations, I n v e s t i g a t i o n s , Office O f f i c e of o f Regional R e g i o n a l Operations, O p e r a t i o n s , Office O f f i c e of o f Regulatory R e g u l a t o r y Affairs, A f f a i r s , FDA F D A 1995) 1 9 9 5 ) (http://www.fda.gov/ora/inspect_ref/igs/gloss.html) ( h t t p : / / w w w . f d a . g o v / o r a / i n s p e c t _ r e f / i g s / g l o s s . h t m l ) 2. 2 . General G e n e r a l Principles P r i n c i p l e s of o f Software S o f t w a r e Validation; V a l i d a t i o n ; Final F i n a l Guidance G u i d a n c e for f o r Industry I n d u s t r y and a n d FDA F D A Staff S t a f f (FDA, ( F D A , Center C e n t e r for f o r Devices D e v i c e s and a n d Radiological R a d i o l o g i c a l Health, H e a l t h , Center C e n t e r for f o r Biologics B i o l o g i c s Evaluation E v a l u a t i o n and a n d Research, R e s e a r c h , 2002) 2 0 0 2 ) (http://www.fda.gov/cdrh/comp/guidance/938.html) ( h t t p : / / w w w . f d a . g o v / c d r h / c o m p / g u i d a n c e / 9 3 8 . h t m l ) 3. 3 . Guidance G u i d a n c e for f o r Industry, I n d u s t r y , FDA F D A Reviewers, R e v i e w e r s , and a n d Compliance C o m p l i a n c e on o n Off-The-Shelf O f f - T h e - S h e l f Software S o f t w a r e Use U s e in i n Medical M e d i c a l Devices D e v i c e s (FDA, ( F D A , Center C e n t e r for f o r Devices D e v i c e s and a n d Radiological R a d i o l o g i c a l Health, H e a l t h , 1999) 1 9 9 9 ) (http://www.fda.gov/cdrh/ode/guidance/585.html) ( h t t p : / / w w w . f d a . g o v / c d r h / o d e / g u i d a n c e / 5 8 5 . h t m l ) 4. 4 . Pharmaceutical P h a r m a c e u t i c a l CGMPs C G M P s for f o r the t h e 21 2 1 st s t Century: C e n t u r y : A A Risk-Based R i s k - B a s e d Approach; A p p r o a c h ; A A Science S c i e n c e and a n d Risk-Based R i s k - B a s e d Approach A p p r o a c h to t o Product P r o d u c t Quality Q u a l i t y Regulation R e g u l a t i o n Incorporating I n c o r p o r a t i n g an a n Integrated I n t e g r a t e d Quality Q u a l i t y Systems S y s t e m s Approach A p p r o a c h (FDA ( F D A 2002) 2 0 0 2 ) (http://www.fda.gov/oc/guidance/gmp.html) ( h t t p : / / w w w . f d a . g o v / o c / g u i d a n c e / g m p . h t m l ) Industry I n d u s t r y References R e f e r e n c e s 1. 1 . The T h e Good G o o d Automated A u t o m a t e d Manufacturing M a n u f a c t u r i n g Practice P r a c t i c e (GAMP) ( G A M P ) Guide G u i d e for f o r Validation V a l i d a t i o n of o f Automated A u t o m a t e d Systems, S y s t e m s , GAMP G A M P 4 4 (ISPE/GAMP ( I S P E / G A M P Forum, F o r u m , 2001) 2 0 0 1 ) (http://www.ispe.org/gamp/) ( h t t p : / / w w w . i s p e . o r g / g a m p / ) 2. 2 . ISO/IEC I S O / I E C 17799:2000 1 7 7 9 9 : 2 0 0 0 (BS ( B S 7799:2000) 7 7 9 9 : 2 0 0 0 ) Information I n f o r m a t i o n technology t e c h n o l o g y – – Code C o d e of o f practice p r a c t i c e for f o r information i n f o r m a t i o n security s e c u r i t y management m a n a g e m e n t (ISO/IEC, ( I S O / I E C , 2000) 2 0 0 0 ) 3. 3 . ISO I S O 14971:2002 1 4 9 7 1 : 2 0 0 2 Medical M e d i c a l Devices- D e v i c e s - Application A p p l i c a t i o n of o f risk r i s k management m a n a g e m e n t to t o medical m e d i c a l devices d e v i c e s (ISO, ( I S O , 2001) 2 0 0 1 ) 9 9 0.00 0.00 0.00