Validation

Validation involves the collection and evaluation of data — from the process design stage through commercial production — which establishes scientific evidence (proof) that a process is capable of consistently maintaining the necessary level of compliance. Here you will find content that discusses the qualification of systems and equipment.

Articles

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Four strategic steps to creating and executing a hybrid audit protocol
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Ending the up-hill battle of Paper-based validation document control
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A CPV approach based only on statistical tools addresses only the operational level of the system; management needs to be involved
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How and why Baxter International implemented an automated continued process verification program
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Reducing process related failures and quality costs; Continued Process Verification can improve control and lower failure rates
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Process design is the key to effective validation