FDA Links

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FDA PART 11 & RISK MANAGEMENT WARNING LETTERS
Two new FDA warning letters both issues April 2005. One mentioning Part 11 non-compliance by name and the other citing lack of adequate risk management activities in a regulated firm.
Part 11 Warning Letter - 479KB     Risk Management Warning Letter - 371KB

Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Applicationnnnnnnnnn
Final Guidance - Aug 2003 - 216KB

Guidance for Industry Part 11, Electronic Records; Electronic Signatures -  Scope and Application
Draft Guidance - Feb 2003 - 44KB

21 CFR Part 11. Electronic Records; Electronic Signatures; Final Rule Electronic Submissions; Establishment of Public Docket; Notice.
21 CFR Part 11 Final Rule - 253KB

  Guidance for Industry (WITHDRAWN)
21 CFR Part 11; Electronic Records; Electronic Signatures Maintenance of Electronic Records
Draft Guidance, July 2002 - 188KB

  Draft of Guidance for Industry-21 CFR Part 11; Electronic Records; Electronic Signatures-Time Stamps. (WITHDRAWN)

Notices of availability for Part 11 draft guidance on validation and a glossary of terms. (WITHDRAWN)
Draft - Guidance For Industry-Glossary of Terms - 116KB
Draft - Guidance for Industry - Validation - 201 KB

Latest compliance policy guidance document regarding 21 CFR Part 11.(WITHDRAWN)
www.fda.gov/ora/~160-850.htm

Electronic Record - Electronic Signatures 21 CFR Part 11 Guidance Document Dockets Established Topics for Guidance Document Development.
www.fda.gov/ohrms/dockets/dockets/dockets.htm 

Downloadable copies of  21 CFR Part 11, the final rule, in both text file format and PDF format.
www.fda.gov/ora/compliance_ref/part11/

Latest District Office Warning Letters from the Center for Drug Evaluation and Research (CDER).
www.fda.gov/foi/warning.htm

A-Z directory of current FDA guidance documents.
www.fda.gov/cder/guidance

Guidance for Industry Computerized Systems Used in Clinical Trials - Addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the FDA. These data form the basis for the Agency's decisions regarding the safety and efficacy of new human and animal drugs, biologics, medical devices, and certain food and color additives.
www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm 

Procedures and Guidance: Implementation of the Government Paperwork Elimination Act specifically states that electronic records and their related electronic signatures are not to be denied legal effect, validity, or enforceability merely because they are in electronic form, and encourages Federal government use of a range of electronic signature alternatives.
Federal Register/Vol. 65, No. 85/ Tuesday, May 2, 2000 - 171KB

Guidance for industry regarding general principles for software validation
www.fda.gov/cdrh/comp/guidance/938.html

Excellent list of links regarding federal, state and local electronic records management practices, guidelines and current technology.
www.fcw.com/topic.asp?topic=recordsmanagement

Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
www.fda.gov/cder/dmpq/cgmpregs.htm

Current Good Manufacturing Practice for Medical Devices
www.fda.gov/cdrh/qsr/intro.html

Computer Security Resource Clearinghouse (CSRC) is designed to collect and disseminate computer security information and resources to help users, systems administrators, managers, and security professionals better protect their data and systems. A primary goal of the CSRC is to raise awareness of all computer systems users -- from novice to expert -- about computer security. This is perhaps the most important way of improving information systems security. 
csrc.nist.gov 

Updated FDAMA dockets
www.fda.gov/ohrms/dockets/dockets/dockets.htm