Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations

FDA-regulated companies are very familiar with a variety of validation processes ranging from full process and facilities validation to that of qualifying individual utilities, equipment, instruments and everything in between. What about software implementation? To what extent do computer and software systems need to be validated? What is the FDA looking for during inspections in regards to validation?

This white paper, 21 CFR Part 11 Computer Systems Validation will explain what companies must do in order to implement and validate computer / software systems to comply with 21 CFR Part 11 and Current Good Manufacturing Practice (CGMP) guidelines.

Downloads:

	White Paper: 21 CFR Part 11 Computer Systems Validation (Risk Mgmt. Plan)
	White Paper: 21 CFR Part 11 - Are You Ready for an FDA Inspection?
	White Paper: 5 Ways to Ensure System Compliance with 21 CFR Part 11
	White Paper: 21 CFR Part 11 MasterControl Product Positioning

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