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Electronic Records/Signatures - Part11

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Guideline from Japan on Electronic Records and Signatures

Standard Operating Procedures

 

SOP
Training for GxP, 21 CFR Part 11 and Computer Validation

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.

 

SOP
21 CFR Part 11 - Scope and Control

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.

 

SOP
Recording of GLP Raw Data

S-149

 

Checklist
Using Electronic Signatures in Regulated Environments

E-152-01

 

SOP
Archiving of GMP Data and Other Documents

S-162

 

SOP
Recording of GCP Source Data

S-163

 

SOP
Archiving and Retrieval of GCP Data and Other Documents Retention

S-164

 

SOP
Testing File Integrity of E-Mail Attachments

S-248

 

SOP
Auditing Laboratory Computer Systems for Data Integrity
S-272-02

 

SOP
Scanning of Paper Records for ISO 17025 Compliant Archiving
S316-02

 

SOP
Data Backup and Recovery

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.

 

SOP
Electronic Audit Trail: Specifications, Implementation and Validation

S-322.

 

SOP
Review of Electronic Audit Trail

S-323

 

SOP
Integrity and Security of Electronic Records

S-324.

 

SOP
Using Electronic Signatures in Regulated Environments

S-325.

 

SOP
Security and Integrity of Electronic Laboratory Data
S-551

 

SOP
SOP Manual Reintegration of Chromatographic Peaks

S-552

Templates / gap analyses / checklists / case studies / examples

Checklist
Security and Integrity of Electronic Data in Laboratories 

E-148-03

 

Checklist
EU GMP Annex 11: Version 2011

E-151

 

Checklist
Electronic Audit Trail

E-152

 

Checklist
Using Electronic Signatures in Regulated Environments

E-152-01

 

Checklist
User Requirement Specifications for Electronic Signatures

E-307_01

Checklist
Using Electronic Signatures in Regulated Environments

E-152-01

 

Checklist
Using Computerized Systems in Clinical Trials

E-154

 

Checklist
FDA Record Retention and Retrieval

E-155

 

Checklist
21 CFR Part 11: Electronic Records, Electronic Signatures

E-168

5 pages - specifically designed for laboratories but also useful for other applications

 

Checklist
Comparison 21 CFR Part 11 - China GMP

E-168-01

 

Checklist
Understanding the FDA Part 11 Validation Guidance

E-169

19 pages, includes tables wit the text, interpretations, examples and recommendations

 

Example
Requirement Specifications for Electronic Audit Trail

E-258

 

Checklist
User Requirement Specifications for 21 CFR Part11

E-307

 

Case Studies
Case Studies: Part 11 Implementation (E-411)

E-411

 

Case Studies
Electronic Audit Trail

E-415

 

Cas

Case Studies
How to Respond to Data Integrity and Security Related FDA Observations (

E-420-01

 

Case Studies
How to Respond to Data Integrity related 483's and Warning Letters
E-425-02

 

Case Studies
How to Avoid Part11 Related 483's and Warning Letters

E-426

 

Case Studies
How to Avoid Data Integrity Related 483's and Warning Letters
426-02

 

Example
Computer System Validation - Policy

K-1318

 

Form
21 CFR PART 11 Project Team
K-1411

 

Example
Letter to the FDA About using Electronic Signatures

K-1412

Companies using electronic signatures must send FDA a letter with the intend to use e-signatures

 

Example
Form to document Part11Training for Accountability of Electronic 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

 

Example
Vision - Electronic Records & Electronic Signature

K-1415

 

Example
Part 11 Objectives

K-1416

 

Example
Implementing Electronic Records & Electronic Signatures and 21 CFR Part 11 Compliance

K-1417

 

Example
Equipment Records

K-3520

 

Master Plan
21 CFR Part 11 Compliance

M-132

 

Primer
21 CFR Part 11 – Electronic Records and Electronic Signatures

M-214

 

Example: Implementation Plan
Implementing 21 CFR Part 11 - Step-by-Step

M-513

Regulatory Reference
US FDA Drug CGMP Laboratory Record Requirements

R-118

 

Regulatory Reference
US FDA Drug CGMP Requirements for Manufacturing and Distribution Records

R-119

Reference papers and presentations, private authors

 

Reference Paper
Interpretations of Part 11 That Require More Discussion.

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

 

Company publication
The impact of 21 CFR Part 11 on Global Manufacturing and Product Safety

A-176

John Blanchard of ARC Advisory Group

 

Reference Paper
Electronic records and signatures in practice

A-177

L. Huber, published in Pharmaceutical Canada

 

Reference Paper
Addressing Validation Rules.

A-178

Very good article on validation needs from Ken Chapman and Paul Winter to meet FDA's Electronic Records requirements

 

Reference Paper
 Way Forward

A-179

Very good article from Ken Chapman and Paul Winter on Electronic Records with his well known common sense approach

 

Reference Paper
Impact of FDA's new Part 11 Draft Guidance.

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.

 

Reference Paper
Impact of Part 11 on Chromatographic Data Systems

A-184

published in the Journal of cGMP Compliance
L. Huber

 

Reference Paper
Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories, Part 1. Overview and Requirements

A-191

published in BioPharm, L. Huber

 

Reference Paper
Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories, Part 2: Security aspects for systems and applications

A-192

W. Winter and L.Huber.

 

Reference Paper
Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories, Part 3. Ensuring Data Integrity of Electronic Records

A-193

W. Winter and L. Huber.

 

Reference Paper
Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories, Part 4. Data migration, long term archiving and ready retrieval

 A-194

W. Winter and L. Huber.

 

Reference Paper
Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories: Part 5. Importance of Instrument Control and Data Acquisition

A-195

published in BioPharm, W. Winter and L. Huber.

 

Reference Paper
Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories: Part 6. Biometrics-Based Authentication - Limitations and Possibilities

A-196

W. Winter and L. Huber

 

Reference Paper
The Benefits of 21 CFR Part 11 Compliance for Discovery

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.

 

White paper
Validation of Computerized Endotoxin Detection Systems

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

 

Reference Paper
ERP/SAP Implementation&Validation at J&J - Case Study

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.

 

Presentation
The Impact of FDA's Part 11 Draft Guidance: 'Scope and Applications'.

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

 

Presentation
FDA's New Enforcement of 21 CFR Part 11 - 2009

P-307

Ludwig Huber

 

Industry Presentation
Impact of Part 21 CFR 11 on Chromatographic Data Systems: Presentation at the IVT Symposium: Electronic Signatures and Records,

P-309

London, February 2000.

 

 

Industry Presentation
How to Prepare Yourself for FDA's New Part 11 Inspection Program, Learn what the FDA is looking for and how to respond

P-310

October 2010

 

Industry Presentation
Understanding FDA's 21 CFR Part 11: Introduction and Strategies and Tools for Implementation (P-311)

P-311

December 2010

 

FDA regulations and official FDA Guidelines

 

FDA Regulation
Code of Federal Regulations, Title 21, Food and Drugs, Part 11

F-282

"Electronic Records; Electronic Signatures."

 

FDA Guidance Part 11 FDA Industry Draft Guidance on 'Scope and Applications'

F-411

August 2003. Currently this is the only FDA guidance document officially available for Part 11.

 

FDA Guidance
FDA Electronic Records: Electronic Signature Certification

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.

 

FDA Guidance
Part 11 FDA Compliance policy guide (withdrawn in February 2003)

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. .

 

FDA Guidance
Part 11 FDA Industry Draft Guidance on Glossary (withdrawn in February 2003)

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.

 

FDA Guidance
Part 11 FDA Industry Draft Guidance on Validation (withdrawn in February 2003)

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.

 

FDA Guidance
Part 11 FDA Industry Draft Guidance on Time Stamps (withdrawn in February 2003)

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.

 

FDA Guidance
Part 11 FDA Industry Draft Guidance on Electronic Records Management (withdrawn in February 2003)

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.

 

FDA Guidance
Part 11 FDA Industry Draft Guidance on Electronic Copies (withdrawn in February 2003)

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

 

FDA Guidance
FDA ORA IOM Electronic Copies Guidance: Section on electronic records.

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.

 

FDA Guidance
Using Electronic Means to Distribute Certain Product Information

F-441

Guidance for using E-mail, Intranet and Internet in FDA Regulated environments

Other regulations, official guidelines and recommendations from industry task forces

Federal Law
The Federal Legislation Electronic Signatures Global and National Commerce Act.

H-126

This Law refers to Electronic Records as Stored on 'tangible media'.

 

Guidance Document
National Archive and Records Management (NARA)
Records Management Guidance for Agencies Implementing Electronic Signature Technologies from the United States National Archives and Records Administration.

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

 

Recommendation from industry
Letter of the Pharmaceutical Research and Manufacturing Association (PhRMA) to the FDA

H-415

Pharma makes several suggestions on the redefining scope and implementation of part 11

Presentations, publications, interviews with FDA personnel (these are not official guidelines)

FDA Presentation
Frequently asked questions and answers.

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

 

FDA Presentation
Computer Validation

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

 

FDA Presentation
Part 11 and FDA Inspections

G-306

Christine Nelson during FDA/industry combined training session on 21 CFR Part 11, Jan 12, 1999

 

FDA Interview
FDA representatives answer questions on Part 11 at the FDA-Industry Training: Electronic Records: Electronic Signatures ,

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

 

FDA Interview
Part 11 audit trail

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.

 

FDA Question and answers
Are E-PROMS considered to be Electronic Records and does Part 11 apply?

G-310

P.Motise, from Q&A session at the IVT ERES conference, Airlington, April 2002

 

FDA Presentation
Update and Q&A's on FDA's Part 11 Activities,

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

 

Meeting minutes
Industry proposals to change the scope and answers from FDA representatives

G-312

Participants: members of Industry Coalition for Part 11 and FDA

 

FDA Presentation
FDA Update on Part 11,

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

 

FDA Presentation
Update on FDA Part 11 Validation Guidance

G-314

Paul Motise at the IVT conference: Computer System Validation and E-records/signatures, Airlington, April 2002

 

FDA Presentation
CDER's 21 CFR Part 11 - Implementation Study

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

 

FDA Presentation:
Update on 21 CFR Part 11 Implementation

G-316

Paul Motise

 

FDA Presentation
Update on 21 CFR Part 11.

G-317

Paul Motise
Topics: History of part 11, key points, FDAdeviations, development of guidance documents.

 

FDA Interview
FDA requirements for computer systems in analytical laboratories.

G-318

Paul Motise
Topics included: long term archiving, SOPs, part 11 and office programs, local vs. global times and others. Berlin, September 1999

 

FDA Presentation
Part 11 - Electronic Records and Signatures, Update as of May 2004

G-321

This was presented by FDA's John Murray. Mr. Murray is a member of FDA's part 11 task force.

 

FDA Presentation
21CFRPart11 - Scope and Application - Inspection and Enforcement Discretion. Consists of 32 slides

G-322

FDA Part 11 Experts on New Scope and Enforcement Discretion for Part 11
Joseph Famulare, Scott McIntire, John. Murray, US FDA

 

FDA Presentation
Update on 21 CFR Part 11

G-323

James McCormack from the FDA

 

FDA Presentation:
Part 11 - News and Views

G-324

Christine Nelson , Food & Drug Administration Center for Devices and Radiological Health

 

FDA Presentation
Current Status and Future Directions of Part 11 (Sept 2004)

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.

 

FDA Presentation
FDA’s Current Interpretation of 21 CFR Part 11 and Guidance for Computerized Systems

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.

 

FDA Presentation
FDA Presentation: Part 11: Where we were, where we are and where we are going,

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.

 

FDA Presentation
FDA Update: Data Integrity and Fraud – Another Looming Crisis?

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.

 

FDA Presentation
FDA Regulatory Perspective: Data Integrity

G-332

Steve Wilson, Deputy Director, Division of Biometrics II, CDER

 

FDA Presentation
Current Phase of the Part 11 Proposed Amendment Process?

G-333

George Smith, GAMP North America Meeting, June 2007

 

FDA Presentation
Edwin Rivera: Investigating OOS Test Results for Pharmaceutical Products

G-334

 

FDA Presentation
George Smith, CDER Part 11 Inspection Assignments
August 2010

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