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Pernille Vestberg

Biography

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How validation teams can work faster without losing control

Adam Smith
Compliance expert

Validation teams are often under pressure to move faster. Projects need to close. Production needs to run. Documentation needs to be approved. At the same time, regulated environments cannot afford shortcuts that weaken control.

The solution is not to remove validation work. The solution is to make the work more precise.

Many validation projects become too large because the scope is not clearly defined. Teams may retest what is already documented, rewrite specifications that are still valid, or treat all changes as equally critical. That creates unnecessary workload without necessarily improving compliance.

A faster validation approach starts with understanding what actually needs control.

Which functions are critical? Which requirements affect quality, data integrity, safety or compliance? Which parts of the system are already documented well enough? Where is supplementary evidence needed? And where can existing documentation be reused with a clear rationale?

This is especially important for older equipment and production systems. Over time, systems change, requirements evolve and documentation becomes fragmented. But that does not always mean a full revalidation is needed. In many cases, a structured review can identify what is already covered and where targeted testing or additional documentation is enough.

The key is traceability. Every decision should be explainable. If something is reused, the rationale must be clear. If something is tested again, the reason must be clear. If something is classified as non-critical, the logic must be documented.

That is how validation teams can work faster without losing control: not by doing less thinking, but by doing less unnecessary work.

Good validation is not measured by the number of documents produced. It is measured by whether the documentation gives a clear, risk-based and reviewable explanation of the validated state.