FDAComplianceDigest

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Part11 SystemComplianceAssessment Checklist

ARTICLEEXCERPTBEGINS

Validation&SystemDocumentation
Requirement

# RuleSection

Requirement ComplianceAction Satisfied? YES Options: YES,NOor n/a MSVM Identifythemethodologyto beusedforvalidation. approvedsystemvalidation methodology. Forexistingsystems,please contacttheBusinessUnitPart11 Compliance Ownertohelpassessvalidation status.

1. 11.10(a) Thesystemisvalidated. Validationofsystems Examplesofmaterialsinasystemvalid ationpackageinclude: SystemDocumentation ApprovedRequirements DesignDocumentation SystemInventory Documentation(HW&SW) SystemTesting RiskAssessment/Classification TestPlan TestReport SystemMaintenanceInformation TrainingRecords BackupProcedures/Disaster RecoverPlan ChangeManagement(Version Control)Procedures ApplicationSupport Documentation 2. 11.10(k)1 Controlsarepresentforthedistribu Adequatecontrols tion,accessanduseofsystems overdocumentation documentationforoperationand maintenance. 3. 11.10(k)2 Revisionandchange Systemsdocumentationreflectsdevelop mentandmodificationsofthesystem

YES Options: YES,NOor n/a YES Options:

Training&SOP
Thereisevidenceofqualification(educa tion,trainingorexperience)forpersons whodevelopedthesystem. Note:TheappropriatelevelofPart 11trainingshouldalsobeprovided. Thereisevidenceofqualifications(educa tion,trainingorexperience)forpersons whomaintainthesystem. Note:TheappropriatelevelofPart 11trainingshouldalsobeprovided. Thereisevidenceofqualifications(educa tion,trainingorexperience)forpersons whousethesystem. Note:Itmaybeappropriateforsomekey userstoalsoreceivePart11training. Ifelectronicsignaturesareused,apolicyis activelyimplemented,sothatindividuals understandthesignificanceof,andare heldaccountablefor,theirelectronic signatures. Note:Thisrequirementismetbythe BusinessUnitimplementingCorporate Part11policy__________thataddresses thesignificanceofelectronicsignatures.

4. 11.10(i) Personswhodevelop, havetheeducation, training,andexper ience 5. 11.10(i) Personswhomaintain, havetheeducation, training,andexperi ence 6. 11.10(i) Personswho usehavethe education,training, andexperience

YES

Options: YES,NOor n/a

YES

Options: YES,NOor n/a

YES

Options: YES,NOor n/a

7. 11.10(j) Writtenpoliciesfor actionsinitiated underelectronic signatures

YES

Options: YES,NOor n/a

RecordIntegrity&Protection

8. 11.10(a) Thereisamethodtodetectchangesmadeto Abilitytodis records(includingdirectrecordchangesthat cerninvalidor bypasssystemcontrols). alteredrecords 9. 11.10.(c) Protectionof records

Options: YES,NOor n/a Options: YES,NOor n/a YES

YES

Thereisamethodtoprotectrecordsfromaccid entalordeliberatedamage(includingdirect recordchangesthatbypasssystemcontrols).

RecordOutput

YES 10 11.10(b) Thesystemhastheabilitytoproducecom . Generateaccur pletecopiesofrecordsinprintedhuman Options: ateandcomplete readableformat YES,NOor copiesinboth n/a humanreadable 11 11.10(b) . Generatein electronicform Thesystemhastheabilitytoproducecom pletecopiesofrecordsinacommon electronicformat(e.g.,ASCII,TXT, DOC,XLS,etc.). YES Options: YES,NOor n/a

Sequence&DeviceControl

N/A 12 11.10(f) Thesystemcontrolstherequiredsequencing . Enforcepermit ofstepsandevents,asappropriate. Options: Note:MarkasN/Aunlessidentifiedasa tedsequencing YES,NOor requirementofthesystem ofstepsand n/a events 13 11.10(h) . Useofdevice checks Thesystemchecksthatdataentriesoroper atinginstructionsoriginateonlyfrom authorizedlocations(e.g.,workstations), asappropriate. YES

Options: Note:MarkasN/Aunlessidentifiedasa YES,NOor requirementofthesystem n/a YES

ApplicationSecurity&UserAuthority

14 11.10(d) Systemaccessislimitedtoonlyauthorized . Limitingsystem individuals. access

Options: YES,NOor n/a

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ThisarticleexcerptiscomplimentsoftheFDAComplianceLearningCommunityofenKap (http://www.enkap.com). ThisdocumentwillbepublishedinitsentiretyintheJanuary2010PremierIssueoftheFDA ComplianceDigest.