Food and Drug Administration (FDA) Links:

Food and Drug Association (FDA) Home Page

Center for Drug Evaluation and Research (CDER) – cGMP Regulations

FDA Enforcement Reports

FDA Federal Register Documents, CFR and Food, Drug & Cosmetic Act

FDA Regulatory Procedures Manual

FDA CDER Guidance Documents Web Page a searchable, topical guide to CDER guidance documents.

• Code of Federal Regulation (CFR) Title 21 A link to the Code of Federal Regulations on the Government Printing Office web site.
• Electronic Records; Electronic Signatures (21 CFR Part 11). These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to promote and protect public health.
• FDA Glossary of Computerized System and Software Development Terminology
• FDA Guide to Inspection of Computerized systems in Drug Processing
• HUMAN DRUG CGMP NOTES
• FDA Warning Letters

Industry Links:

Parenteral Drug Association (PDA)

International Society for Pharmaceutical Engineering (ISPE)

National Institute of SRMCSrds and Technology (NIST)

NIST – Software Verification and Validation Process Institute of Electrical and Electronics Engineers (IEEE)

Instrumentation, Systems, and Automation Society (ISA)

International Organization for SRMCSrdization (ISO)

International Links:

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