Electronic Records/Signatures - Part11
Download more than 500 documents: SOPs, examples, templates, checklists,
FDA waning letters, 483 inspectional observations, FDA and other official
guidelines, presentations/publications from FDA personnel.
Guideline from Japan on Electronic Records
and Signatures
S-125
Adequate qualification of people is important to meet business and
regulatory requirements. Training can close the gap between actual
qualifications and requirements of the assigned job. This procedure should
ensure that people working on computers in regulated environments receive
adequate training and that the training is documented for compliance with
regulations.
S-137
The SOP applies to electronic records in GxP environments and to
other records, such as paper or microfiche that originated from
electronic records. The SOP reflects FDA’s approach for scope and
application of 21 CFR Part 11.
S-149
E-152-01
S-162
S-163
S-164
S-248
S-317
Availability of records is important not only for compliance but also for
business reasons. For example distribution records must be readily available
in case of a product recall and without batch records or analytical batch
records drug products cannot be shipped. Also there is always a possibility
that computer data can be lost in case of hardware, software or operation
problems. Therefore good data back-up strategies and procedures are
important for quick data recovery in case of such problems. Back-up and
restore of electronic records. This SOP applies for manual and automated
back-up and restoring of data, operating system files, configuration
parameters and application software.
S-322.
S-323
S-324.
S-325.
SOP
Security and Integrity of Electronic
Laboratory Data
S-551
SOP
SOP Manual Reintegration of
Chromatographic Peaks
S-552
E-148-03
E-151
E-152
E-152-01
E-307_01
E-152-01
E-154
E-155
E-168
5 pages - specifically designed for laboratories but also useful for
other applications
E-168-01
E-169
19 pages, includes tables wit the text, interpretations, examples and
recommendations
E-258
E-307
E-411
E-415
E-420-01
E-426
K-1318
K-1412
Companies using electronic signatures must send FDA a letter with the
intend to use e-signatures
K-1413
Employees need to be formally trained that electronic that electronic
signatures have the same meaning as handwritten signatures. Trainees should
sign a statement that they have understood the meaning of e-signatures
K-1415
K-1416
K-1417
K-3520
M-132
M-214
M-513
R-118
R-119
A-174
Manuscript of a paper presented at the IVT Conference on 21CR Part11 in
Washington, April 20, 1999. Ken Chapman collected information and case
studies from the industry in preparation for a heated discussion with Paul
Motise at the IVT conference. In this paper, Ken documented major industry
concerns about part 11.
Ken Chapman
A-176
John Blanchard of ARC Advisory Group
A-177
L. Huber, published in Pharmaceutical Canada
A-178
Very good article on validation needs from Ken Chapman and Paul Winter to
meet FDA's Electronic Records requirements
A-179
Very good article from Ken Chapman and Paul Winter on Electronic Records
with his well known common sense approach
A-180
The paper has been authored ed by Wolfgang Winter and Ludwig Huber and
published in Biopharm. On a variety of examples it demonstrated which
records should comply with part 11 und which ones don't need to. Especially
valuable is a table with records that are required by predicate rules such
as cGMP.
A-184
published in the Journal of cGMP Compliance
L. Huber
A-191
published in BioPharm, L. Huber
A-192
W. Winter and L.Huber.
A-193
W. Winter and L. Huber.
A-194
W. Winter and L. Huber.
A-195
published in BioPharm, W. Winter and L. Huber.
A-196
W. Winter and L. Huber
A-198
The 15 pages paper discusses: The Benefits of 21 CFR Part 11 Compliance
for Discovery - Even if the FDA Never Asks for Your Records. Main
benefits are to protect patents and higher efficiency through automation.
The paper describes very much in detail how such systems should be designed,
implemented and validated.
A-199
and FDA’s 21 CFR Part 11: Electronic Records/Electronic Signatures
Regulation.
(What do end users have to do? What do vendors have to do?)
From Associates Cape Cope, Inc
A-266
This 22 pages cover story of IVT's GxP journal from October 2003 gives
you an inside look at how Johnson&Johnson successfully implemented and
validated an enterprise resource planning system. Compliance with part 11
was one of the goals. Digital signatures are used as security feature to
ensure that certain tasks are only performed by authorized users. Signatures
are linked to part 11 compliant e-audit trails that document the name of the
undersigned person, purpose of the signature and data and time. The article
describes very much in detail on how the system has been validated and gives
examples for validation deliverables for various life cycle phases.
P-298
With situation analysis, reasons for the change, comparison between old
and new guidances, examples for high/low risk systems, the industry
reaction, recommendations
P-307
Ludwig Huber
P-309
London, February 2000.
P-310
October 2010
P-311
December 2010
F-282
"Electronic Records; Electronic Signatures."
F-411
August 2003. Currently this is the only FDA guidance document officially
available for Part 11.
F-418
FDA ORA Field Management Directive No. 146. Explains how to file
certification documents with the FDA according to 21 CFR Part 11 if persons
wish to use electronic signatures on electronic records in regulated
activities.
F-422
The guidance document has been withdrawn from the FDA website mainly
because all existing part 11 guidance documents have been withdrawn in
February 2003. However there is absolutely nothing wrong with this guidance
and many of the ideas in this guidance are repeated in FDA's final part 11
guidance: Scope and applications. .
F-423
The guidance document has been withdrawn from the FDA website mainly
because all existing part 11 guidance documents have been withdrawn in
February 2003. However there is absolutely nothing wrong with this guidance
others than it is not very detailed.
F-424
The guidance document has been withdrawn from the FDA website mainly
because all existing part 11 guidance documents have been withdrawn in
February 2003. However there is absolutely nothing wrong with this guidance.
F-425
The guidance document has been withdrawn from the FDA website mainly
because all existing part 11 guidance documents have been withdrawn in
February 2003. However it is a very good document to get an impression on
what FDA inspectors may want to see during inspections.
F-426
The guidance document has been withdrawn from the FDA website because
there were some requirements that are very difficult to meet, e.g.,
reprocessing of data during the entire record retention time as required by
predicate rules. Otherwise the guidance has good practical recommendations
for archiving of electronic records.
F-427
The guidance document has been withdrawn from the FDA website because it
was not in line with FDA's cGMP Initiative for the 21st Century. It is still
a useful document to get recommendations on how to make copies of electronic
records, but it should be combined with risk assessment procedures
F-439
The Investigations Operations Manual (IOM) is the primary source of
guidance regarding FDA policy and procedures for field investigators and
inspectors. The section on records instructs field investigators on how to
obtain electronic records. Recommendations are in line with 21 CFR Part 11.
F-441
Guidance for using E-mail, Intranet and Internet in FDA Regulated
environments
H-126
This Law refers to Electronic Records as Stored on 'tangible media'.
H-130
This guidance focuses on records management issues involving records that
have been created using electronic signature technology.
H-283
Guideline On the use of electromagnetic
records and electronic signatures in applications etc. for approval or
licensing etc. of drugs etc.
English version published in 2005
H-415
Pharma makes several suggestions on the redefining scope and
implementation of part 11
G-304
Paul Motise during the FDA/Industry Combined Training Session on 21 CFR
Part 11: Electronic Records; Electronic Signatures FDA on Jan 12, 1999
G-305
Janis. v. Halverson during the FDA/Industry Combined Training Session on
21 CFR Part 11: Electronic Records; Electronic Signatures FDA on Jan 12,
1999
G-306
Christine Nelson during FDA/industry combined training session on 21 CFR
Part 11, Jan 12, 1999
G-308
Jan 12, 1999. A lot of details.
Topics: Archiving, audit trails, certification, e-signatures, guidance
documents, open vs. closed systems, raw data, scope of part 11, software
suppliers, validation
G-309
Paul Motise to an industry coalition on the subject of audit trail.
Using different examples of draft and signed documents and manual data base
entries and transcription to computers, Paul M. explains when audit trail
should begin.
G-310
P.Motise, from Q&A session at the IVT ERES conference, Airlington, April
2002
G-311
FDA's inspection and enforcement practices, main deviations, development
of guidance documents, impact of the US E-sign act, response of other
agencies, e.g., US FDA.
Christine Nelson
G-312
Participants: members of Industry Coalition for Part 11 and FDA
G-313
Interpretation of FDA part 11 guidance documents with outlook to FDA's
initiative to Pharmaceutical cGMPs for the 21st Century and how this will
impact part 11.
Jennifer Thomas, CBER
G-314
Paul Motise at the IVT conference: Computer System Validation and
E-records/signatures, Airlington, April 2002
G-315
Summary of industry problems reported to the FDA, but also FDA's concerns
and main problems software vendors have with part 11
Greg Brolund CDER/FDA, November 1999
G-316
Paul Motise
G-317
Paul Motise
Topics: History of part 11, key points, FDAdeviations, development of
guidance documents.
G-318
Paul Motise
Topics included: long term archiving, SOPs, part 11 and office programs,
local vs. global times and others. Berlin, September 1999
G-321
This was presented by FDA's John Murray. Mr. Murray is a member of FDA's
part 11 task force.
G-322
FDA Part 11 Experts on New Scope and Enforcement Discretion for Part 11
Joseph Famulare, Scott McIntire, John. Murray, US FDA
G-323
James McCormack from the FDA
G-324
Christine Nelson , Food & Drug Administration Center for Devices and
Radiological Health
G-326
Joe Famulare, Director of the Division of Manufacturing and Product
Quality, CDER Office of Compliance gave a presentation at the Joint PDA/FDA
meeting on September 21 about Part 11. Most interesting was on outlook into
the future Currently the FDA is requesting comments on the re-examination of
Part 11 in areas where part 11 most likely will change: These are areas that
could be less prescriptive and detailed, possible elimination of the
distinction made between 'open' and 'closed' systems, possible additional
requirements for investigation and follow up when security breaches occur,
and risk mitigation for legacy systems. Famulare also gave specific
information and examples of systems that are now outside of the scope of
Part 11 and for changes of legacy systems that will not effect Part 11
legacy system status.
G-327
The paper was presented by FDA's national Part 11 expert George Smith at
the IVT Computer System Validation Conference in Alexandria in April 2005.
Main topics of the presentation have been: Problems with the original rule,
validation and risk-based approach in light of recent guidance, examples of
predicate rules that may trigger Part 11, acceptable forms for archiving,
conditions under which electronic records can be deleted, guidance on
electronic records & signatures and citizen’s petition to revoke part 11. He
also gave examples when changes to a legacy system generally would not
change Part 11 legacy status: Hardware maintenance actions such as upgrades
or replacements, some software maintenance actions such as upgrades to an
operating system or DBMS (DOS to windows, ORACLE upgrade, Software
Maintenance to resolve originally intended use issues and functionality
[software problem resolution], and relocation or redistribution of a system.
Changes that may invalidate Part 11 Legacy System status include: Change in
intended use, change in functionality and changes in the use of collected
data. Mr. Smith also gave an outlook of part 11 and FDA's further plans. The
FDA is still collecting and evaluating industry inputs and plans to publish
the new proposed rule in the federal register before the end of 2005.
G-328
This was presented by FDA's George Smith at the 2006 GAMP Americas
Meeting, March 2006. Mr. Smith is a member of FDA's part 11 task force.
G-330
Edwin Rivera-Martinez, Chief of CDER's Investigations and Preapproval
Compliance Branch at Division of Manufacturing & Product Quality gave a
presentation on FDA compliance update at the 31st International GMP
Conference on March 15, 2007, at the University of Georgia in Athens. While
the presentation was announced as FDA compliance update, the entire
presentation focused on integrity and fraud of electronic records in
analytical laboratories. This was done as a result of recent inspection
findings, Rivera-Martinez told the audience. The presentation gave examples
of problems with integrity of electronic data. The major reason for data
manipulation was to bring initial out-of-specification results into
specifications, for example: "Intentional computer manipulation of
chromatograms by cutting and pasting chromatographic data so that initial
out-of-specification test results are brought into specification", "Changing
chromatogram processing parameters", "Altering weights of samples and
standards in analytical calculations", and "Manipulation of chromatograms by
lab chemists without justification and changing of calculations to bring
out-of-specification results within specification". Towards the end
Rivera-Martinez told the audience, what FDA plans to do, for example, to
focus inspections more on data integrity and fraud and to train
investigational staff on uncovering data integrity, data manipulation and
fraud. He also gave recommendations on what the industry can do.
G-332
Steve Wilson, Deputy Director, Division of Biometrics II, CDER
G-333
George Smith, GAMP North America Meeting, June 2007
G-334
G-337
Part 11 Add-on Results
This was presented by FDA's George Smith, the head of FDA's part 11 task
force.
Mr. Smith gives an update of FDA's Part 11 Program as of June 2011
G-338