Automating Paper-based Quality Systems in FDA-Regulated Environments

The release of FDA's most recent guidance, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practices (CGMP), directs how FDA-regulated companies can take advantage of current technology to automate quality system to comply with CGMP's.

The Guidance specifically emphasizes the need to automate Corrective and Preventive Actions (CAPA), Change Control, Training Control and ensure that proper Software Validation is completed. The white papers listed below describe how companies can take advantage of today's technology to implement quality systems to comply with CGMP's.

Downloads:

	Q&A: CDER Offical Offers Tips on GMP Inspections
	White Paper: Change Control - Quality Improvements in FDA and ISO Environments
	White Paper: Does Your CAPA System Need a CAPA?
	White Paper: Automating Document Control Processes to Comply with FDA and ISO Requirements
	White Paper: Automating Training Processes to Comply with FDA and ISO Requirements
	White Paper: 21 CFR Part 11 - Risk of Non-compliance
	Q&A: FDA's Quality Systems Approach to Pharmaceutical CGMPs