Resources

PharmaSys wants you to be educated in the validation process and informed of industry trends. We are providing a few links to assist you.

• 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.
• HUMAN DRUG CGMP NOTES
• FDA Warning Letters
• DISQUALIFIED/RESTRICTED/ASSURANCES LIST FOR CLINICAL INVESTIGATORS
• FDA Guide to Inspection of Computerized systems in Drug Processing
• FDA Glossary of Computerized System and Software Development Terminology
• Association for the Advancement of Medical Instrumentation
• Biotechnology Industry Organization
• Medical Device Manufacturers Association