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
  • URS
  • RTM
  • DS
  • FAT and SAT
  • Protocols (DQ, IQ, OQ, PQ and PPQ)
  • Test protocol, test references and test plans
  • Execution of tests
  • Deviation and change control
  • Reporting

Contact

John Albertsen

+45 2123 5168