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.
