CSV Related Links
- FDA Web Site for 21 CFR Part 11
- FDA Compliance Policy Guide ( CPG 7153.17)
- Computerized Systems Used in Clinical Trials (Guidance for industry)
Articles of Interest
- Regulatory Beat: FDA Moves to Streamline GMP Inspections. Taken from Bio Pharm International Magazine, June 1, 2007.
- Risk-Based Equipment Qualification: A User/Supplier Cooperative Approach
- Outsourcing and Contract Manufacturing on the Pharmaceutical Industry
- RFID yes, UPC no and probably not
- Wireless reliability in industrial automation
- Computer Validation Master Planning
- Pharmaceutical cGMPs for the 21st Century - A Risk Based Approach. Final Report from the U.S. Food and Drug Administration, September 2004
- Guidance for Industry - Q9 Quality Risk Management from the U.S. Food and Drug Administration, June 2006
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