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Do I need to perform a validation?

Validation is per definition the activity to ensure that a system works according to its intended use in an organisational context.

Since both the Aligned eQMS and Aligned Elements is a highly configurable system, built to adapt to your individual company needs, your Aligned system needs to be validated based on the adaptations you do.

For these reasons, the Aligned products are not delivered in a validated state.

To assist you with the validation we do provide you with:

  • a validation package containing an example validation
  • a pre-filled FDA QSR 21 CFR Part 11 assessment
  • access to our internal development and verification documents

We can also assist you with performing the actual validation activities.