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Validation Stages and SOP’s

During a validation exercise, it can be difficult to figure out at what stage the process is at. It can be quite chaotic at times with production supervisors, operators, technicians, validation personnel...

The Qualified Person (QP) and Validation

It is a common misunderstanding that validation exercises are not the concern of the on-site Qualified Person. This can often be experienced, particularly in larger companies, where the Validation department...

An Easy Way to Validate a SQL Report

When validating computer systems and applications an array of screenshots and other such supporting documentation is frequently used. All too often, supporting information is simply stored in a database...

Validation Protocol Execution Tips – Top 10

So you have a validation protocol to execute and you want it to run smoothly without raising too many deviations and discrepancies (if possible). What is the best approach to take and what are the main...

Featured E-Learning Module

There are few stated requirements for Good Documentation Practices (GDP), instead, it's an expected practice and not stated or included in any Code of Federal Regulations (CFR) requirement.
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