Building the Right Team and Resource Model to Support Quality System and Validation Activities

Highly trained specialists in the areas of regulatory, quality, IT, engineering and others, are relied upon to plan, implement, and monitor qualification and/or validation activities in highly regulated industries, such as pharmaceutical and medical device manufacturing. These projects and programs may include activities like writing and executing CQV and CSV protocols; ensuring documentation, SOPs, laboratory, manufacturing and packaging operations are robust; creating and running test scripts; analyzing existing processes for improvement opportunities; and auditing the documentation trail for compliance.

The processes behind these activities must demonstrate that they lead to a consistent, high-quality product, and are central to producing safe and effective products in a fully compliant state.

This whitepaper describes critical steps an organization can follow to ensure Commissioning, Qualification and Validation (CQV) and Computer Software Assurance (CSA) program success every time.

 

 

Building the Right Team and Resource Model to Support Quality System and Validation Activities

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