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.



Pharma’s hybrid inspection model

Four strategic steps to creating and executing a hybrid audit protocol

Why Are Paper Mountains Still Common in Validation?

Ending the up-hill battle of Paper-based validation document control

Management’s Role in Sustaining Continued Process Verification

A CPV approach based only on statistical tools addresses only the operational level of the system; management needs to be involved

Compliance Management

How and why Baxter International implemented an automated continued process verification program

A Case for Stage 3 Continued Process Verification

Reducing process related failures and quality costs; Continued Process Verification can improve control and lower failure rates

Are Your Validation Efforts Based on Sound Process Design?

Process design is the key to effective validation