Training Control is Crucial to FDA-Regulated Companies

MasterControl Training Tech Paper describes how important training control is for life sciences. The FDA stipulates personnel training requirements for medical device companies in 21 CFR Part 820.25 and for pharmaceutical companies in 21 CFR Part 211.25. The paper details how MasterControl Training automates training control, tracking and reporting to ensure compliance with FDA CGxP requirements and 21 CFR Part 11.

This paper identifies the basis for the requirement and examines the associated challenges for meeting the requirement and the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking requirements is presented.

Watch Customer Video MasterControl Training Module (2:29) Using MasterControl for FDA Compliance (3:53)

Downloads:

	White Paper: Automating Training Control Processes to Comply with FDA and ISO Requirements
	White Paper: Change Control - Quality Improvements in FDA and ISO Environments
	White Paper: Automating Document Control Processes to Comply with FDA and ISO Requirements
	White Paper: 21 CFR Part 11 Computer Systems Validation (Risk Mgmt. Plan)
	White Paper: 21 CFR Part 11 Risk of Noncompliance
	White Paper: 21 CFR Part 11 MasterControl Product Positioning

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