case studies-part11-implementation-case-studies.doc

7/26/2019 Case Studies-part11-implementation-case-studies.doc

1/47

Case Studies

Part 11 Implementation

Revision 2.00October 2009

These are case studies for Part 11 Implementation. They are proposals and startingpoints only. The type and extent of documentation depends on the process environment.The proposed examples should be adapted accordingly and should be based onindividual situations. There is no guarantee that the case studies will pass a regulatoryinspection.

Publication from

www.labcompliance.comGlobal on-line resource for validation and compliance

Copyright by Labcompliance. This document may only be saved and viewed or printedfor personal use. Users may not transmit or duplicate this document in whole or in part,in any medium. Additional copies and licenses for department, site or corporate use can

be ordered from www.labcompliance.com/solutions.While every effort has been made to ensure the accuracy of information contained inthis document, Labcompliance accepts no responsibility for errors or omissions. o

liability can be accepted in any way.

Labcompliance offers books, master plans, complete uality Packages with validationprocedures, scripts and examples, !"Ps, publications, training and presentationmaterial, user club membership with more than #$$ downloads and audio%webseminars. &or more information and ordering, visit www.labcompliance.com%solutions.


2/47


3/47


4/47

'ase !tudies Page ) of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

1. PRPOS!

In . fter Part 11 became effective in ugust 188*, significant discussions ensuedamongst industry, contractors and the gency concerning the interpretation andimplementation of the regulations. 9hile initial &+ guidance documents indicateda very broad scope with significant problems to fully implement Part 11, in ($$4 the&+ released a new guidance promoting a more narrow scope =5ef. 1.(>. The &+intends to publish a revision of Part 11 in ($$*%: which will be very much in linewith the guidance as published in ($$4. 9hether a system or record needs tocomply with Part 11 depends on business practices and the risk a system or recordhas on product 6uality and patient safety. ;sing practical examples, these casestudies should help to implement Part 11 re6uirements according to the newinterpretation in the most cost/effective way.

2. SCOP!

'omputer systems used in &+ and e6uivalent international regulatedenvironments.

#. R!$!R!%C!S

1111 'ode of &ederal 5egulations, Title (1, &ood and +rugs, Part 11 lectronic

5ecords? lectronic !ignatures? &inal 5ule? &ederal 5egister 7( =#)>, 14)(8/14)77.

1111 &+ @uidance for Industry Part 11, lectronic 5ecords? lectronic !ignatures?

!cope and pplications =&inal version ugust ($$4>.

1111 !"P !/14*- APart 11 !cope and 'ontrolsB.

vailable through www.labcompliance.com%solutions%sops.

1111 !"P !/14)- A5isk ssessment for !ystems ;sed in @xP nvironmentsB.


www.labcompliance.com (Replace with your companys name) FOR INTERNAL!E
http://www.labcompliance.com/solutions/sopshttp://www.labcompliance.com/solutions/sops


5/47

'ase !tudies Page # of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

1111 !"P !/(*1- A0alidation of 'ommercial "ff/the/!helf ='"T!> 'omputer

!ystemsB.vailable through www.labcompliance.com%solutions%sops.

1111 !"P !/(7)- A0alidation of !preadsheet pplicationsB.


1111 !"P !/(*$- A0alidation of lectronic +ocument


6/47

'ase !tudies Page 7 of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

!ignature executed, adopted or authoriDed by an individual to be thelegally binding e6uivalent of the individualEs handwrittensignature.

3andwritten!ignature

The scripted name or legal mark of an individual handwritten bythat individual and executed or adopted with the presentintention to authenticate a writing in a permanent form. The actof signing with a writing or marking instrument such as a pen orstylus is preserved. The scripted name or legal mark, whileconventionally applied to paper, may also be applied to otherdevices that capture the name or mark.

@xP 5ecord 5ecord re6uired to be maintained by predicate rules orsubmitted to the &+ under the predicate rules.

'losed

!ystem

n environment in which system access is controlled by

persons who are responsible for the content of electronicrecords that are on the system.

"pen !ystem n environment in which system access is not controlled bypersons who are responsible for the content of electronicrecords that are on the system.

5egulatedctivity

ny activity re6uired by a predicate rule.

"riginal5ecord

lectronic records originally captured by the computer system.This can be a manual data entry or a record captured from anautomated system. 9hen records are converted to a standard

format, e.g., an original 9ord document to P+& format, theseare no longer original formats.



7/47

'ase !tudies Page * of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

*. !+(,P'!S

5 1

/(/C ClientServer ased (nalsis Sstem

#.1.1 pplication and ;se

The system is a client%server based chromatographic data system used in a' laboratory for analysis of finished product testing. The client P' controls3PL' e6uipment, ac6uires data, integrates peaks and calculates sampleamounts. 5esults together with original records and integration parametersare transferred to a server with applications for database searching andarchiving.

#.1.( !ystem !ummary and 2usiness Process

#.1.4 5ecommendations and +ocumentation

Sstem Cate3or 'onfigurable "ff/the/!helf 'omputer !ystem

Records re4uired b yes no



8/47

'ase !tudies Page : of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

predicate rule5 xplanation-

Laboratory test results are re6uired to be maintained by @ 'omputer !ystemsB and in5ef. 1.:- A5isk/2ased 0alidation of 'omputer !ystemsB.

Fey deliverables are-

0alidation plan.

5e6uirement specifications.

0endor assessment.

Installation 6ualification.

"perational 6ualification with testing of key parameters that

can be influenced by the userGs environment. Performance 6ualification.

0alidation summary report.

6ow is aut7enticitensured5

computer recording handwritten signatures

e/signatures digital signatures

xplanation-

The computer identifies and records people through user I+.



9/47


;sers sign paper records.

6ow is confidentialitensured5

controlled access to data encryption

xplanation-

'ontrolled limited access to system and data to authoriDedindividuals through ade6uate policies and system functionality.;sers can enter the system and applications only after enteringa password and user I+.

6ow are recordsarc7ived5

paper P+&%TI& original electronic records

xplanation-

5ecords that re6uire a signature are printed and signed. 'opiesof original records, meta data and processed records aremaintained in original electronic form and are available forinspections for as long as the data in the laboratory are

available for reprocessing. This includes records of electronicaudit trails.

Hustification-

The records provide a high value and are available to the

department for further evaluation or reevaluation and paperprintouts.

'opying a process to other formats does not fully preserve

the original content.

'omment- 5etention of electronic records after the results havebeen approved would not be necessary if users would not have

the possibility to reevaluate and print data and if all content andmeaning of the electronic records to demonstrate compliancewith regulations could be printed.

Ot7er Controls

uthority checks The system checks if users are authoriDed to perform allowedtasks.

People 6ualification Persons who develop, maintain or use electronic systems havethe education, training and experience to perform theirassigned tasks. This is ensured through the !"P in 5ef. 1.8-ATraining for @xP, (1 '&5 Part 11 and 'omputer 0alidationB.

5e6uirements forelectronic signatures

ot pplicable

!ystemdocumentation

ppropriate control over system documentation is ensuredthrough following !"P !/1$#- A+ocument


10/47

'ase !tudies Page 1$ of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5 2

6P'C Sstem for Stabilit Testin3

#.(.1 pplication and ;se

The P' controls 3PL' e6uipment, ac6uires data, integrates peaks andcalculates sample amounts. 'hromatograms and results are printed andsigned. 5esults together with original records and integration parameters arearchived on +0+s.

#.(.( !ystem !ummary and 2usiness Process

#.(.4 5ecommendations and +ocumentation


Records re4uired bpredicate rule5

yes no

xplanation-

!tability test results are re6uired to be maintained by @


11/47


Impact on product4ualit5

high medium low

xplanation-

!tability test results obtained in pharmaceutical ' labs

typically are high risk records because if they are wrong,products with not well defined impurities may go out to themarket.

6ave users access tot7e sstem5

yes no

xplanation-

;sers have access to the P', to chromatography software, toprocessing parameters and results.

Can users c7an3erecords5

yes no

xplanation-

;sers can interactively change processing parameters andreprocess, e.g., reintegrate data.

If users can c7an3erecords8 7ow is t7ec7an3e documented5

electronic audit trail others

xplanation-

5elevant software applications on the chromatography softwarehave built/in electronic audit trail.

Is validation re4uired8and if es8 w7at aret7e e deliverables5

yes no

xplanation-

!ystem is validated following the !"Ps in 5ef. 1.#- A0alidation

of 'ommercial "ff/the/!helf ='"T!> 'omputer !ystemsB and in5ef. 1.:- A5isk/2ased 0alidation of 'omputer !ystemsB.


0alidation plan.


0endor assessment.



can be influenced by the userGs environment.

Performance 6ualification.





xplanation-





12/47

'ase !tudies Page 1( of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation



xplanation-

'ontrolled limited access to system and data to authoriDed

individuals through ade6uate policies and system functionality.;sers can enter the system and applications only after enteringa password and user I+.



xplanation-

5ecords that re6uire a signature are printed and signed. 'opiesof original records, meta data and processed records aremaintained in original electronic form and are available forinspections for as long as the data in the laboratory areavailable for reprocessing. This includes records of electronic

audit trails.Hustification-





'omment- 5etention of electronic records after the results havebeen approved would not be necessary if users would not havethe possibility to reevaluate and print data and if all content andmeaning of the electronic records to demonstrate compliancewith regulations could be printed.

Ot7er Controls




ot pplicable

!ystemdocumentation



13/47


14/47

'ase !tudies Page 1) of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

by Part (11.


high medium low

xplanation-

9rong oven temperature can impact product 6uality.


yes no

xplanation-

;sers have access to the electronic records.


yes no

xplanation-

5ead only data.

If users can c7an3e

records8 7ow is t7ec7an3e documented5


ot applicable as users cannot change data.


yes no

xplanation-

!ystem is validated following the !"Ps in 5ef. 1.#- A0alidationof 'ommercial "ff/the/!helf ='"T!> 'omputer !ystemsB and in5ef. 1.:- A5isk/2ased 0alidation of 'omputer !ystemsB.


0alidation plan.

5e6uirement specifications. 0endor assessment.









xplanation-


;sers sign electronic records.



xplanation-

'ontrolled limited access to system and data to authoriDedindividuals through ade6uate policies and system functionality.;sers can enter the system and applications only after entering



15/47

'ase !tudies Page 1# of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

a password and user I+.



xplanation-

"riginal records, meta data and processed records aremaintained in original electronic form and are available forinspections for as long as the data in the laboratory areavailable for reprocessing. This includes records of electronicaudit trails.

Hustification-





Ot7er Controls




Part 11 re6uirements for electronic signatures are met.

!ystemdocumentation



16/47


5 4

Sstem for 'aborator !4uipment /ualification

#.).1 pplication and ;se

The system is a computeriDed 3PL' system used for automated 3PL'e6uipment 6ualification.

#.).( !ystem !ummary and 2usiness Process

#.).4 5ecommendations and +ocumentation



yes no

xplanation-

Laboratory e6uipment calibration and 6ualification recordsre6uired to be maintained by @


17/47

'ase !tudies Page 1* of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

xplanation-

5elative product tests results 6ualification records are mediumrisk.


yes no

xplanation-

;sers have access to the P', application software andprocessing parameters.


yes no

xplanation-

;sers can interactively change processing parameters andreprocess, e.g., reintegrate data.

If users can c7an3e

records8 7ow is t7ec7an3e documented5


xplanation-

'onsidering the risk level, electronic audit trail is not re6uired.


yes no

xplanation-

!ystem is validated following the !"Ps in 5ef. 1.#- A0alidation of'ommercial "ff/the/!helf ='"T!> 'omputer !ystemsB and in5ef. 1.:- A5isk/2ased 0alidation of 'omputer !ystemsB.


!tatement from the vendor that the software has been

validated during development.





xplanation-





xplanation-'ontrolled limited access to system and data to authoriDedindividuals through ade6uate policies and system functionality.;sers can enter the system and applications only after enteringa password and user I+.



xplanation-



18/47

'ase !tudies Page 1: of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5ecords are printed and signed and archived as paper.

Ot7er Controls

uthority checks The system checks if users are authoriDed to perform allowed

tasks.



ot pplicable

!ystemdocumentation



19/47


5 5

atc7 Recordin3 and Printin3 : %o Stora3e of !:Records

#.#.1 pplication and ;se

PL' controller is used to control, record and print process parameters andactual conditions such as temperature and pressure of manufacturinge6uipment. 2atch records are printed on/line and signed on paper.

#.#.( !ystem !ummary and 2usiness Process

#.#.4 5ecommendations and +ocumentation

Sstem Cate3or 6uipment 3ardware with Local 'ontroller and 5ecording


yes no

xplanation-

2atch records are re6uired to be maintained by @


20/47

'ase !tudies Page ($ of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

2atch parameters typically are high risk records because theyare used as criterion for batch release.

6ave users access to

t7e sstem5

yes no

xplanation-

;sers have access to the system through the PL' controller.


yes no

xplanation-

;sers cannot change records.



ot pplicable

Is validation re4uired8

and if es8 w7at aret7e e deliverables5

yes no

xplanation-

6uipment hardware and the PL' controller should be 6ualified.


ualification plan.


0endor assessment.


"perational 6ualification.






xplanation-

;sers sign batch records. 9ith the signature they also ensurethat they are the owners of the record.



xplanation-

ccess to paper printouts is controlled.6ow are recordsarc7ived5


xplanation-

There are no electronic records.

Ot7er Controls

uthority checks ot pplicable

People 6ualification Persons who use the e6uipment have the education, training



21/47


22/47

'ase !tudies Page (( of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5 6

Oven wit7 Card Reader


n oven is programmed through a local keyboard. Parameters and actualconditions are stored on a card reader. The reader is transferred to a P' thatreads and prints stored information. The paper printouts are signed. Theelectronic records are stored in a database for later searching, sorting etc.





yes no

xplanation-

Processing conditions are re6uired to be maintained by @


23/47

'ase !tudies Page (4 of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation


high medium low

xplanation-

9rong oven temperature can have an impact on product 6uality.


yes no

xplanation-

;sers have access to oven temperature on P'.


yes no

xplanation-

;sers can interactively change temperature records on P'.

If users can c7an3erecords8 7ow is t7e

c7an3e documented5


xplanation-

Temperature changes are captured through electronic audit trailon P'.


yes no

xplanation-

!ystem is validated following the !"Ps in 5ef. 1.#- A0alidationof 'ommercial "ff/the/!helf ='"T!> 'omputer !ystemsB and in5ef. 1.:- A5isk/2ased 0alidation of 'omputer !ystemsB.


0alidation plan.


0endor assessment.









xplanation-The computer identifies and records people through user I+.




xplanation-

'ontrolled limited access to system and data to authoriDedindividuals through ade6uate policies and system functionality.



24/47

'ase !tudies Page () of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

;sers can enter the system and applications only after enteringa password and user I+.

6ow are records

arc7ived5


xplanation-

5ecords are printed, signed and archived on paper.

Hustification-

Temperature settings are copied to paper printing content

and meaning.

95I@- There must be a way to capture the audit trail onpaper, or it must be recorded in electronic form

5ecommendation- 'hange software such that temperaturecannot be changed.

Ot7er Controlsuthority checks The system checks if users are authoriDed to perform allowed

tasks.



ot pplicable

!ystem

documentation

ppropriate control over system documentation is ensured

through following !"P !/1$#- A+ocument


25/47

'ase !tudies Page (# of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5 7

;as7er wit7 6and7eld Controller

#.*.1 pplication and ;se

washer is controlled by a handheld controller. The method is programmedon an external computer and operators load a memory chip with the pre/programmed wash cycle into the controller. "perators press start. The cyclebegins and the controller records and prints a cleaning log.

#.*.( !ystem !ummary and 2usiness Process

#.*.4 5ecommendations and +ocumentation

Sstem Cate3or 6uipment with Local 'ontroller


yes no

xplanation-

'leaning records are re6uired to be maintained by @


26/47


4ualit5 xplanation-

Insufficient cleaning of glassware can have an impact onproduct 6uality.


yes no

xplanation-

;sers have access to the system.


yes no

xplanation-

!oftware does not allow changing cleaning records.



ot pplicable


yes no

xplanation-

9asher with handheld controller is 6ualified.


ualification plan.






ualification summary report.




xplanation-

;sers sign cleaning records. 9ith the signature they alsoensure that they are the owners of the record.



xplanation-

'ontrolled limited access to system and data to authoriDedindividuals through ade6uate policies and procedures.



xplanation-

5ecords on paper provide content and meaning.

Ot7er Controls



27/47

'ase !tudies Page (* of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

uthority checks ot pplicable

People 6ualification Persons who operate the e6uipment have the education,training and experience to perform their assigned tasks. This is

ensured through the !"P in 5ef. 1.8- ATraining for @xP, (1'&5 Part 11 and 'omputer 0alidationB.


ot pplicable

!ystemdocumentation



28/47

'ase !tudies Page (: of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5 8

sin3 a


29/47


$urt7er actions 2ecause electronic records are not re6uired by predicate rules,we can stop any further activities.

5 9

sin3 an !cel Template as a Calculator


n xcel spreadsheet is used as a sophisticated calculator. +ata are enteredinto the spreadsheet from a paper lab notebook. . xcel calculates final resultsthat are printed, signed and archived



Sstem Cate3or 'onfigurable "ff/the/!helf !oftware


yes no



30/47

'ase !tudies Page 4$ of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

xplanation-

Laboratory records are re6uired to be maintained by @


31/47






xplanation-

The computer identifies and records people through user I+.The user name as identified by the system is printed togetherwith the results.




xplanation-

;sers ensure confidentiality of data on paper.

6ow are records

arc7ived5


xplanation-

"riginal records and calculated results are archived on paper.

!preadsheets can be stored preferably together withcorresponding


32/47

'ase !tudies Page 4( of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5 1

sin3 !cel for


33/47



high medium low

xplanation-

'orresponding records are high risk records because they are

used as criterion for batch release.


yes no

xplanation-

;sers have access to the system, to original raw data and finalresults.


yes no

xplanation-

;sers can interactively change original records.

!preadsheets are loaded from a write protected server. Thesource location of the spreadsheet is printed together with theresults. This ensures that only the non/modified originalspreadsheet is used for the calculations.



xplanation-

9e need Part 11 compliant electronic audit trail. This function isnot available through standard xcel but has to be addedthrough special add/on software.

Is validation re4uired8

and if es8 w7at aret7e e deliverables5

yes no

xplanation-

The spreadsheet and the add/on software are validatedfollowing the !"P in 5ef. 1.7- A0alidation of !preadsheet

pplicationsB.


0alidation plan.



"perational 6ualification with testing of security access and

correct inputs%outputs. ll functions that have been

programmed with 02 are tested. 9e also test properfunctioning of the add/on modules with e/audit trail and e/signatures.

Performance 6ualification. Includes regular


34/47

'ase !tudies Page 4) of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

ensured5 e/signatures digital signatures

xplanation-


;sers sign electronic records.



xplanation-




xplanation-

9e electronically store-

"riginal records as captured from the automated instrument.

The spreadsheet with all calculations.

'alculated results.

Ot7er Controls


People 6ualification Persons who develop, maintain or use electronic systems have

the education, training and experience to perform theirassigned tasks. This is ensured through the !"P in 5ef. 1.8-ATraining for @xP, (1 '&5 Part 11 and 'omputer 0alidationB.


lectronic signatures comply with Part 11 re6uirements

!ystemdocumentation



35/47

'ase !tudies Page 4# of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5 11

sin3 ,S (ccess as a


yes no

xplanation-

"riginal training records =raw data> are available andmaintained on paper. Training records are re6uired by (1 '&5Parts :($ and #: and are also re6uired by Part (11 todemonstrate compliance with the re6uirement to train people,



36/47


but if these records are readily available on paper there is noneed for additional records in electronic form.

$urt7er actions 2ecause electronic records are not re6uired by predicate rules,

we can stop any further activities.

5 12

sin3 a ;ord Processor for Paper SOPs

#.1(.1 pplication and ;se

#.1(.( !ystem !ummary and 2usiness Process

#.1(.4 5ecommendations and +ocumentation



37/47

'ase !tudies Page 4* of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation



yes no

xplanation-

ll &+ and e6uivalent international regulations re6uire writtenprocedures for routine tasks.


high medium low

xplanation-

+epending on the nature and use of the !"Ps, they can have ahigh, medium and low impact on product 6uality. &or thepurpose of this exercise they are classified as a medium impact.


yes no

xplanation-

;sers of !"Ps donGt have access to the electronic version ofthe !"P.


yes no



xplanation-

;sers cannot change electronic !"Ps, but authors will use theoriginal electronic version for updates. 2efore reusing theelectronic !"P the integrity should be demonstrated. This is

achieved through calculating, storing, recalculating andcomparing


38/47

'ase !tudies Page 4: of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

xplanation-

'ontrolled limited access to the electronic version to authoriDedauthors through ade6uate policies and system functionality.

uthors can access records only after entering a password anduser I+.



xplanation-

!"Ps used by users are signed and archived on paper.

!ource records are archived as electronic records.

Ot7er Controls

uthority checks The system checks if authors are authoriDed to performallowed tasks.



ot pplicable

!ystemdocumentation



39/47


5 13

sin3 a ;ord Processor for !lectronic SOPs


isused to draft !tandard "perating Procedures. !"Ps are electronicallyapproved and electronically signed. P+& is published on the companyIntranet. The original 9ord file is maintained for future updates but not usedby users of the !"P.





yes no

xplanation-

ll &+ and e6uivalent international regulations re6uire written



40/47

'ase !tudies Page )$ of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

procedures for routine tasks.


high medium low

xplanation-

+epending on the nature and use of the !"Ps, they can have ahigh, medium and low impact on product 6uality. &or thepurpose of this exercise they are classified as a medium impact.


yes no

xplanation-

;sers have access to the electronic P+& file of the !"P.

uthors have access to the electronic source document.


yes no

xplanation-P+& files are created as non/editable files. Therefore users of!"Ps cannot change the !"Ps.

uthoriDed authors can change the original source file.



xplanation-

;sers of !"Ps cannot change !"Ps.

uthors can change. uthoring and updates are done within adocument management system with electronic audit trailfunctionality.


yes no

xplanation-

9ord processors are widely used for commercial software.There is no need to verify standard functions. 9hat we do isdocument the vendor, product and version number. "r in otherwords, we only perform I. In addition, we verify limited accessand audit trail functionality.


I.

" =limited access, e/audit trail>.




xplanation-


uthor and reviewer sign electronic records.

6ow is confidentialit controlled access to data encryption



41/47

'ase !tudies Page )1 of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

ensured5

xplanation-


individuals through ade6uate policies and system functionality.;sers, authors and reviewers can enter the system andapplications only after entering a password and user I+.

6ow are records usedand arc7ived5


xplanation-

!ource documents are maintained as electronic records.

P+& files are used as electronic files.

Please note- If users cannot use electronic files for day/by/dayuse, they must be printed, manually signed and distributed onpaper.

Ot7er Controls




lectronic signatures comply with Part 11.

!ystemdocumentation ppropriate control over system documentation is ensuredthrough following !"P !/1$#- A+ocument


42/47

'ase !tudies Page )( of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5 14

Paper Scannin3 for !lectronic (rc7ivin3

#.1).1 pplication and ;se

scanner with appropriate software is used to convert paper records toelectronic records for easier searching and archiving. !cans are converted toP+& files.

#.1).( !ystem !ummary and 2usiness Process

#.1).4 5ecommendations and +ocumentation

Sstem Cate3or 'onfigurable "ff/the/!helf !ystem


yes no

xplanation-

9e assume that records are re6uired by one or more predicaterules.


high medium low

xplanation-



43/47

'ase !tudies Page )4 of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

9e assume that records have a high impact on product 6uality.


yes no

xplanation-

;sers have access to the scans and P+& files.


yes no

xplanation-

;sers cannot change P+& files. They are stored as non/editable files.



xplanation-

;sers cannot change electronic files.


yes no

xplanation-

The scanning process should be validated. This should ensurethat the scanned copies provide the content and meaning of theoriginal paper record.

The entire scanning and archiving process is validated followingthe !"Ps in 5ef. 1.14- A!canning of Paper 5ecords for @xP'ompliant rchivingB.


+escription on how the scanning system is used.

5e6uirement specifications for scanning.

+ocumentation stating which scanner and which software

and version have been used.

!ummary report.




xplanation-

"riginal paper records are signed if necessary.

!ignatures are carried into the electronic P+& file. This is

allowed as long as signatures are for internal use and for the&+. 'are must be taken if signatures have a meaning for 4 rdparty contracts. problem may occur if, for example, a ';director signs a batch release. This needs to be assessed anddiscussed with the signing parties.

If there are any 6uestions, each copy should be certified.



xplanation-



44/47

'ase !tudies Page )) of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation




xplanation-

Paper records can be destroyed if-

The process has been validated.

!ignatures on the P+& files are considered to be legally

valid.

It is recommended that original paper records are kept for 4months. 9ithin this timeframe should have the right toverify accuracy of scans.

Ot7er Controls




ot pplicable

!ystemdocumentation ppropriate control over system documentation is ensuredthrough following !"P !/1$#- A+ocument


45/47

'ase !tudies Page )# of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation

5 15

Clinical Stud Reportin3 over t7e Public Internet

#.1#.1 pplication and ;se

'linical study samples are shipped from the sponsor to a contract laboratoryfor analysis. 5esults are reported back through e/mail attachments over thepublic Internet. 5aw data and test results are maintained and archived by thecontract lab.

#.1#.( !ystem !ummary and 2usiness Process

#.1#.4 5ecommendations and +ocumentation



yes no

xplanation-

'linical study data are re6uired to be maintained by @ood'linical Practice regulations.



46/47


47/47

'ase !tudies Page )* of )*+ocument umber- /)11 0ersion 1.xx pril 1, ($1(Part 11 Implementation



xplanation-


individuals through ade6uate policies and system functionality.;sers can enter the system and applications only after enteringa password and user I+.

9hen data are transferred through the public Internet, datamust be encrypted.



xplanation-

'linical study data are maintained as original electronic records.

Ot7er Controls




lectronic signatures comply with (1 '&5 Part 11.

!ystemdocumentation


case studies-part11-implementation-case-studies.doc

Documents