Pharma – Validation
Validation / qualification of processes / equipment in the pharmaceutical industry is subject to regulatory requirements. AL Engineering has many years of experience in validating / qualifying processes / equipment for pharmaceutical companies nationally and internationally.
AL Engineering can help you define the right validation strategy and ensure implementation and execution. Whether large installations, new equipment or re-validation, we can assist you with the task.
AL Engineering can offer tailor-made templates based on industry best practices. We can also carry out all validation activities according to your quality system and wishes, including designing documents such as:
- Risk assessment
- Validation Plan
- FAT and SAT
- Protocols (DQ, IQ, OQ, PQ and PPQ)
- Test protocol, test references and test plans
- Execution of tests
- Deviation and change control
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