Change Control in the FDA-Regulated Industry

Topics:
Financial Regulations,
Strategic Management Tools
Tags:
Change Control,
Change Control Procedure
Source:
MetricStream

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Overview: Change control is the most critical element in a pharmaceutical or biotech company's quality management system - inadequate change control procedures end up creating a huge risk of non-compliance. The FDA's guidance for Industry clearly reinforces the importance of implementing an effective change control procedures as a critical component in an overall quality system - see "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (CGMP)". It's important for FDA-regulated companies to be able to implement a quality system that automates change management and change control procedures and ensures that they are in compliance with GxPs and 21 CFR Part 11.

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