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Part 11 primer. master plan, project plan, examples, checklists, audio seminar and 11 SOPs for easy implementation

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Frame work to develop your own Part11 project plan

 

Guides you through your Part 11 project: step-by-step, as easy as 1-2-3.

 

Lear how to define risk categories for computer systems and how to justify and document your decisions

 

All you need to know  about basics of Part 11 and FDA's new approach for implementation

 

A total of 11 SOPs are included in the the Labcompliance Part 11 compliance package.

Examples and Case Studies help to implement Part 11 requirements consistently and effectively. They are all included in the Part 11 compliance package from Labcompliance.

Two Audio Seminars are included in the Part 11 compliance package. Useful to train yourself and others
- Part 11 Introduction and Strategies for Implementation
- Preparing your organization for the New Part 11

Reference Publications from Dr. Ludwig Huber help to get an in depth understanding on selected requirements of Part 11.

 

Learn from the FDA about Part 11: past, current and future.

Learn from FDA warning letters what FDA inspectors look for and what mistakes others make, so you can avoid them.

Learn through interactive video seminar about FDA's 'NEW' Part 11, what's coming and how to implement.

Learn from FDA 483's and from detailed EIR inspection reports  what FDA inspectors look for, what questions they ask and if company's response is satisfactory.  483's and EIR's typically are not available from FDA's public website.

 

 

 

 

FDA and Industry Guidance for 21 CFR Part 11

When 21 CFR Part 11 was released in August 1997 the industry was not sure on how to implement it. The FDA has released an number of guidance documents, most of the have been withdrawn. Industry task forces have also developed an published recommendation. This site includes links to all FDA documents related to part 11. Withdrawn guidance are indicated as such.

FDA Regulations/Guidance

 

FDA Regulation

21 CFR Part 11: Electronic Records and Electronic Signatures

Published in August 1997

 

FDA Guidance

21 CFR Part 11: Scope and Applications

Published in August 2003

 

FDA Guidance

21 CFR Part 11: Compliance Policy Guide

withdrawn in February, 2003, as part of FDA's 21st century drug CGMP initiative

 

FDA Guidance

21 CFR Part 11: Validation

This draft guidance has been withdrawn form the FDA Website as part of the drug CGMP initiative for the 21st century. However, most of the statements in the guidance are still very much appropriate and subject to FDA inspections. The guide is especially useful for users of computer systems.

 

FDA Guidance

21 CFR Part 11: Glossary of Terms

August 2000 (draft) (withdrawn)

 

FDA Guidance

21 CFR Part 11: Time Stamps

March 2002 (draft) (withdrawn)

 

FDA Guidance

21 CFR Part 11: Maintenance of Electronic Records

July 2002 (draft) (withdrawn)

 

FDA Guidance

21 CFR Part 11: Electronic Copies of Electronic Records

July 2001 (draft) (withdrawn)

 

FDA Guidance

Using Computers in Clinical Trials

May 2007

 

US FDA Information

IOM Chapter 5 Establishment Inspection

Subchapter 520+ :Electronic Records

Industry Contributions

 

Position Paper

PhRMA's Position on Part 11 - Letter to the FDA

 

Discussion Paper

Implementation of 21 Code of Federal Regulations, Part 11; Electronic Records; Electronic Signatures; Scope of the rule

FDA discussion with Industry Coalition on Part 11

 

White Paper

ISPE: Risk-Based Approach to 21 CFR Part 11