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Guidance For FDA Staff and Industry
Validation of Computerized Liquid Chromatographic Systems, August 31, 1993
Guidance for Industry: General Principles of Software Validation, June 1, 1997
ORA Guide to Inspections of: Computer Issues; Updated April 2001
Guide to Inspection of Computerized Systems in Drug Processing, February, 1983
Guide to Inspections of Computerized Systems in the Food Processing Industry, Post 1997
Glossary of Computerized System and Software Development Terminology, 8/95
21 CFR Part 11; Electronic Records; Electronic Signatures Validation, August 2001
Guide To Inspections Of Pharmaceutical Quality Control Laboratories, July, 1993
Guidances and Information Sheets on Good Clinical Practice in FDA-Regulated Clinical Trials
Guidance Documents Index
Guidance for Off-the-Shelf Software Use in Medical Devices; Final 1999
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002
Proposed Regulations and Draft Guidances on Good Clinical Practice and Clinical Trials
Guideline of General Principles of Process Validation (May 1987, originally published by CDER, CBER, and CDRH and presently recognized by CDER, CBER, and CVM).
Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance, April 1996
FDA Reference Room
Federal Food, Drug, and Cosmetic Act
Milestones in U.S. Food and Drug Law History
Federal Register
Dockets Management
Public Use Forms and How to Obtain Them
Warning Letters and Responses
U.S.C. TITLE 18 - CRIMES AND CRIMINAL PROCEDURE
FEDERAL FINES AND SENTENCING LAWS
USSC Federal Sentencing Guidelines
Frequently Requested Documents and 483s
Regulatory Procedures Manual March 2004
Legal Considerations in Designing & Implementing Electronic Processes: A Guide for Federal Agencies, U S DePartment of Justice
Records Management Guidance for Agencies Implementing Electronic Signature Technologies, National Archives & Records Administration
Federal DEBARMENT LIST (individuals and/or firms legally prohibited from particpating in the processes of manufacturing, packaging or holding of drugs or food)
FDA/ORA Regulatory Procedures Manual, August 1997
FDA/ORA Compliance Policy Guides Manual, Updated April 23, 2001
Enforcement Policy: 21 CFR Part 11, Sec. 160.850; 05/13/1999, (CPG 7153.17)
Legal Considerations; Designing & Implementing Electronic Processes: A Guide for Federal Agencies, 01/11/01, U S Dept. of Justice
Records Management for Agencies Implementing Electronic Signature Technologies, 01/11/01, National Archives & Records Administration
List of Venders Claiming 21CFR11 Compliance Services & Products Compiles by Serentec Inc for FDA, 03/06/01
Guide to Inspection of Computerized Systems in Drug Processing
Biotechnology Inspection Guide Reference Materials and Training Aids
Guide to Inspections of Bulk Pharmaceutical Chemicals
Guide to Inspections of High Purity Water Systems
Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories
Guide to Inspections of Pharmaceutical Quality Control Laboratories
Guide to Inspections Validation of Cleaning Processes
Guide to Inspections of Dosage Form Drug Manufacturer's - CGMPR'S
Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation
Guide to Inspections of Sterile Drug Substance Manufacturers
Guide to Inspections of Topical Drug Products
Guide to Inspections Oral Solutions and Suspensions
Managing the Risks from Medical Product Use: Creating a Risk Management Framework
FDA Presentations and Publications
PowerPoint Presentation: Computerized Systems Used in Clinical Trials by David A. Lepay, MD, PhD Director, Division of Scientific Investigations, June 8, 1998, Electronic Record Keeping
PowerPoint Presentation: The Facts About Source Documents FDA Requirements Related to Source Documents in clinical trials 312.62 (b) cont, 21 CFR 11 Electronic Records; Electronic Signatures, Updated: 07-02-99
Presentation: Paul Motise gives an update on 21 CFR Part 11. Topics: 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.
Interviews: FDA representatives answer questions on part 11 at the FDA-Industry Training: Electronic Records: Electronic Signatures , on Jan 12, 1999.
Presentation from FDA's Paul Motise during the FDA/Industry Combined Training Session on 21 CFR Part 11: Electronic Records; Electronic Signatures FDA on Jan 12, 1999: Frequently asked questions and answers. 01/99
Interview: Paul Motise answered questions at the conference: FDA requirements for computer systems in analytical laboratories. Topics included: long term archiving, SOPs, part 11 and office programs, local vs. global times and others, 09/99
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