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FDA Documentation

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FDA Links

Some of the files below are in Adobe PDF format and require Acrobat Reader.
To suggest new FDA links click here.

The FDA in conjunction with their new GMP initiative has issued a guidance document outlining their new approach to the scope and applicability of 21 CFR Part 11. This approach is based on the FDA's risk-based assessment for regulatory compliance.

USEFUL LINKS

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

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

Recently Posted FDA Warning Letters.
FDA Warning Letters

Current FDA (CDER) guidance documents.
FDA (CDER) Guidance Documents

A-Z Index of FDA website
FDA A-Z

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
General Principles of Software Validation; Final Guidance

Information on FDA Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs.
Information on cGMPs

Current Good Manufacturing Practice for Medical Devices
FDA Medical Device Quality Systems Manual

Computer Security Resource Center (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 


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