Bayer @

02-DEZ-2002
BBYER
19:24
+49
FIG LE’JERKUSEN
214
3055563
s.O1
Bayer @
Bayer AG
Pharma Operations/Quality Assurance
Integrated Quality Management
Kaiser-Wilhelm-Allee 1
Building E 28
5 1368 Leverkusen
Germany
December 02,2002
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rochillc, MD 20852
Re: Docket No. OOD- 1539, Draft Guidance for Industry; 21 CFR Part 11; Electronic Records;
Electronic Signatures, Maintenance of Electronic Records
Bayer appreciates the opportunity to provide comments on the Draft Guidance for Industry: 21
CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records. As
a manufacturer of pharmaceuticals, biologicals, medical devices, animal health products, and
consumer care products, 2 1 CFR Part I 1 Electronic Records and Electronic Signatures has a
significant impact on the Bayer organization. The comments included as in attachment to this
letter represent the current thinking of subject matter experts within Bayer.
In general, the guidance document as written goes beyond the objective to provide guidance of
the Part 11 rule. In some aspects it prescribes a substantial expansion of the scope of Part 11
functional requirements. This expansion does not increase data integrity, product quality or
health safety. Maintenance requirements should not impose extraordinary burdens of time,
money and technology on the healthcare industry.
We recommend revising the guidance document to reflect the original scope of the Part 11 rule.
If you have any questions regarding our comments, please contact me.
Sincerely,
Dr. Erwin Wenning
PH-OP-QA-IQMKomputer
Tel: 001-2 14-30-35308
Fax: 00 l-2 14-30-50025
/
Validation
Attachment: Bayer Comments Guidance for Industry: 2 1 CFR Part 11; Electronic
Records; Electronic Signatures, Maintenance of Electronic Records
Bayer Comments
Guidancefor Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Maintenance of Electronic Records
Draft Guidmw - September 2002
Docket No. OOD-1539
2. Scope
Page5
4.1 What does Part 11
require?
Page6
4.1WbatdoesPti 11
require?
Page8
Document states“...compatible with FDA’s
public healthresponsibilities”.
This requirement should be changed to
“generally equivalent to paper records and
handwrittensignaturesexecutedon paper.”
Documentstates“Accordingly, the signature
manifestationinformation, associatedwith
an ekctmnic record that is subject to this
requirement, must be maintined f%orthe
durationof the recordretentionperiod.“
The requirement shoutd be changed to
“Accordingly, the printed name of the
signer,the date and time of signing and what
the signature means, associated with an
electronic record that is subject to this
requirement, must be mainhimd for the
duration of the record retentionmxiod.”
Delete statement“authentic, and compatible
with
ale
FDA’S
public
health
responsibilities.”
There is no need to substitutenew wording
for the wording in the original rule. It does
not confer clarity and introducesnew areas
of debateon interpretation.
It is heIpfut to specifywhat constitutesthe
“siguaturemanifestationinformation”
expected.
To our understanding the meaning of
“euthentic” is equivalent to ‘k~stworthy”.
For a guideline the statement“compatible
with FDA’s public health responsibilities”
does not elevate the understandingof Part
11 requirements.
5.3 ContinuedAvailability Document states“You shoufdperiodically
Accessto a representativenumberof records
and Readability Of
mess a representativenumberof eIectronic to ensurereadabilityis not recommendedfor
ElectronicRecord
recordsto ensurethat record contentscan
the intendedpurpose.This mipfit be an
I
Bayer Comments
Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Maintenance of Electra& Records
Draft Guidance - September2002
Docket No. 0
Information ShouldBe
EIWXd
Page9
Pages9-10
dill be read and evafuatedthroughoutthe
recordsretention period.“
For the intention of tis sectiona physical
test of the readabilityof the entire media
(e.g. surfncescan)would be more
aDDroDfiate.
5.3 ContinuedAvailability At tbe end of the section 5.3 the following
and ReadabilityOf
sentewe should be added “‘For the purpose
of long term retention, electronic records
ElectronicRecord
Information Should Be
may be retained in a format that differs from
the orirjnal.”
Ensured
5.4 Ehxtronic Records
Documentstates‘You shoulddetermine
what storageconditions are appropriatefor
ShouldBe StoredUnder
Appropriate
the specificelectronicmedia,and then
EnvironmentalConditions maintainthoseconditionsthroughthe record
retentionperiod. You shouldmonitor those
condkion~... ...suchfactorsa~temperature,
humidity, dust, vibration, and sourcesof
electromagneticand radiofrequency
interference.”
ylpropriateapproachafter migration and/or
ransformationof recordsin order to verify
x validatethe migratio&ansfonnation.
It is important to recognize that de-facto
datnbatxstandardsand ‘TechnofogyNeutral
Formats’offer benefits for the long-term
retentionof requiredelectronicrecords.
3itical storagecm&ions are dependenton
he type of storagemedia.
This requirementshouldbe changedto “You
shouldmonitor critical conditionsdepending
on the media.Critical conditionscould be
temperature,hnmidity, dust,vibration, and
2
Bayer Comments
Guidance for Industry: 21 CFR Part 11; Elecinnic Records; Electronic Signatures; Maintenance of Electronic Recorda
Draft Guidance - September 2002
electromagneticand radiokquency
i5terfereIlce.”
Page10
Page11
S-5The Ability To m
4n ElectronicRecord’s
informationThroughout
ItsRecord5Rele5tion
PeriodShouldBe
Pnsfxved
Ducllme5tstates‘~ughout
the records Part 1 I requiresonly the ability to generate
retention period, the ability to process
information in an efectronic rsGordshould
not diminish.”
This requiremat should he changed to
Throughout the records retention period,
electronicrecord should be maintainedin a
mmner that allows the electronic record’s
infimndon to generatecopiesin hm
and
computerreadableform that are suitablefor
FDA hpection, review, and copying.”
5.5The Ability To Process Documentstates:“Accordingly, where you
4n ElectronicRecord’s
could usecomputertechnologiesto search,
sort, ur manipulateinformation in an
klfolmation Throughout
original eledxonicrecord,you shouldbe
Its RecordsRetention
PeriodShouldBe
able to usecomputertechnologiesto
Preserved
performthe samekind of processingon
informationin the maintainedelectronic
recurd.”
This requirement needsto be deleted
accurateand completecopiesin both
electronicand humanreadableform.
Thereforemaintainingprocesscapability of
the old systemis substantialexpansionof
scopeuf Part 11 functionalrequirementsthat
shouldgo throughthe proper FDA rule
making prucessrather than being introduced
via guidance.
This appliesto the entire section5.5.
Typically the accuracyand integrity of the
record can be maintained,but the
functionality and the featnresof the original
applicationsgeneratingthe record are not
possibleto maintainunder any reaWc and
cost effective archivingapproachavailabfe
aY.
Part 1I requiresonly the ability to generate
accurateand completecopiesin both
electronicand humanreadableform.
Thereforenniintainingprocesscapability of
the old systemis substantialexpansionof
3
Bayer Comments
Goidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Maintenance of Electronic Records
Duff Gnidauce - September 2002
scopeof Part 11 functionalrequirementsthat
shouldgo throughthe proper FDA rule
makingprocessrather than being introduced
via guidance.
Page11
5.5 The Ability To Pmcess
An Electronic Record’s
[nformationThroughclut
tts RecoNlsReteution
PeriodShouldBe
Preserved
Document states‘For example,if you could
automatidly searchfor words in the text of
an etectmnic record, sort or find values in a
table, or perform cakulations in a
spreadsheet,you should be able to process
infctrmation in a hke manner for the
electronic record over the entire records
retention period. This abiljty (or
functionality) derives largely from the
hardware and so&are used to extract
information horn the electronic record, as
well as t&e electronic record format itself.
You should include this ability among your
specifications in your procedures and
controls.”
This requirement should be changed to
‘7hroughout the records retention period,
elechmic record should be maintained in a
manner that allows the electronic record’s
information to generatecopiesin human and
computerreadableform that are suitable for
Mahaining processcapability oTthe old
systemis substantialexpansionof scopeof
Part 11 functional requirementsthat should
go through the proper FDA rule making
processrather than being introducedvia
guidance.
Acceptablealternativesare addressedin the
predicaterules. For exampfein the GMPs
section211S180 (d) and tie GLPs section
58.195(g), the rule states“Recordsrequired
by this part may be retainedeither as
original recordsor astrue copiessuch as
photocopies,microfihn, microfiche, or other
accuratereproductionsof the original
records.” This dearly showsthe intent to
retain the informationand doesnot require
reprocessing.”Requirementfor reprocessing
shouldbe limited to thosestatedin a
predicaterule and not be introducedthrough
Part 11 guidance(s).
Bayer Comments
Guidance for Industry: 21 CFR Part 11; Electronic Records; Eleclronic Signatures; Matotensnce of EMronic Records
Draft Guidauee - September2002
Docket No. OOD-1539
Page12
6.1 The Time Capsule
Approach
Page14
6.2 The Electronic
RecordsMigration
Approach
PageI8
FDA inspection,review, and copying.”
Documentstates‘Throughout the records
retentionperiod, you would keep the
cmnputer system functional and makeno
changesto the computingenvironment.”
This requirementshouldbe changedto
“Throughoutthe recordsretentionperiod,
you would keep the computersystem
iimctional.Changescould be necessaryto
keeosvsteml-imctionalitv.”
Documentstates“However, you should
carefuly considerwhen it woufd be prudent
to discardthe old electronicrecordsand/or
The statement“no changes”is too
restrictive. Someminor changesmay be
TEcessq for syWnl maintenancewithout
compromisingthe tie capsuleapproach.
The statementimplies that the old electronic
systemwould still be maintainedfor some
pfxiod of time a&f3 the electronicrecords
SySbXkl...”
were migratedto the new system. This
requirementwould negatethe benefits of
Concernsshouldhe removed
datamigration. If properly validata one
shouldhave assurancethat the integrity of
electronicrecordsis preservedduring and
post migratioIl.
As audit trails are system-or vendor-specific
6.2.1.3ElectronicRecord Documentstates‘Where a migration, in
Integrity Attributes Should effect, createsa new electronicrecord . .. the it might be difficult or even impossibleto
audit trail for the migratedelectrunicnxxxd add informationto this original audit trail of
Be Preserved
would have to cover this creation”
a recordwhen migrating the record to a new
system.It shouldbe acceptableto maintaiu
This requirementshouldhe changedto
separatedocumention for ma&nance,
“Where an electronicrecord is mimted ...
archivingor migrationof the recordsbeside
Bayer Comments
Guidance for Industry: 21 CFB Part 11; Eleetronk Records; Electronic Signatures; Maintenance of Electronic Records
Draft Guidance - September 2002
appropriatedocumentationshouldbe
available.”
Page19
Page20
the original audit trail. Suchseparate
documentationcould be an additionalaudit
trail or validationdocumentation.
Furthermorea copy of the data is not a
human created{or modified) record. A copy
of an electronicrecorddoesnot createa
“new” recordif the information is the same.
621.4 The Ability To - Documentsfates“In the migration approach, Refer to commentson section5.5.
the new compukr systemshould enableyou
ProcessInformation In
Electronic Records Should to search,soti and processinformationin the
migratedelemcmicrecordat leastat the
Be Preserved
samelevel as what you could attain in the
old system.”
6.2.1.5 Unavoidable
DifferencesAnd Losses
Shouldbe AccountedFor
And ExplainedIn The
Migraled Electronic
RecordOr New System
Documentation
Page20
6.2.1.5Unavoidable
DifferencesAnd Losses
Shouldbe AccountedFor
This reauirementneedsto be deleted.
Documentstatesu Justprior to performing
fhe electronicrecordmigration a trusted
third party from outsideof the organization
that has someresponsibilityfor the
electronicrecordverities the digital
sign&m using the old systemsmethod.”
The requirementof a third party
involvementis a substantialexpansionof
scopeof Part 11 fktctioniii requirementsthat
should go through the proper FDA rule
making processrather than being &roduced
via guidance.
This appliesto all trustedth*d party
citationsin this chapter.
This requirementneedsto be deleted.
Documentgives an examplefor migration of For migration of digital signed electronic
digital signedelectronicrecords.This
recordsit is neckry to have the complete
and accurateinformationabout tbe original
chapterneedsto be revised.
Bayer Comments
Guidance for Industry: 21 CFR Part Xl; Electronic Records; Eiedonic Signatures; Maintenar~e of Electronic Records
Draft Guidance - September 2002
hcket No. 01
And Explain&l ht The
Migrated Electronic
RecordOr New System
Documentation
Page21
6.2.I.5 Unavoidable
DifferencesAnd Losses
Shouldbe AccountedFor
And ExplainedIn The
Migrated Electronic
RecordOr New System
DDCUmentation
Page20
6.2.1.5Unavoidable
DifferencesAnd Losses
Shouldhe AccountedFor
And ExplainedIn The
Migrated Electronic
RecordOr New System
Documentation
digital signingavailablea&r migration.
V the migratedelectronicrecord is kept in a
closedsystema digital signatureis no longer
requiredafter migration.
rt must be clear &at you are not migrating
the signaW itself, but rathermigrating a
representationof the fact of the signature.
Documentgivesan examplefor migration of
color codesand requiresthe creationof an
electmnicrecmd to documentthis
migration.
This exampleshouldbe extendedas follows:
“Besidesan electronicrecord other
documentationforms e.g. validation
documentatiooshouldbe adeoa.”
Insert after first sentence of the chapter
(“...is preservedand presented.“):
‘“The fundamentalobjective of the migration
is to preservethe essentialmeaning of the
information asjudged by expertsin the field
to be equivaienlto the original in the context
of its stated,actualor intendeduse.”
Migration to new systems may result in
changesin appearanceas well as analytical
resultcalculationprecisionfrom the originaf
system.Recognizingthis it is imporlau! that
the essentiatmeaning of the information not
Lhange and that only that information
relevant to essential meaning need be
migrated
7