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Laboratory equipment

Pharma company


  • Installation of standard off-the-shelf laboratory equipment​ with embedded IT-system.
  • Procurement of the laboratory equipment was done end budget-year with no proper initial requirements made, e.g. to FDA GMP and specifically Part 11 compliance.
  • GAP assessment on ‘as-is’ as compared to ‘to-be’. Remediation on GAP’s identified to ensure current compliance with FDA and EU GMP.
  • Integration of the equipment IT system into an existing IT infrastructure.​
  • Specification, test and qualification of the IT solution.

Solution - Proces

  • Roadmap to ensure compliance with current FDA and EU GMP, including remediation meetings with vendor and pharma company.
  • IT and laboratory equipment risk assessment​ and requirement specifications​.
  • Design specifications (interfaces/integration)​.
  • IT O&M instructions (interfaces/integration)​.
  • Qualification (planning, protocols, reporting)​​.
  • Project management​.
  • Perform design qualification​ (DQ).
  • Infrastructure integration​.
  • Execute IT test and qualification (IQ, OQ, PQ).


  • Input for ensuring more effective and compliant procurement based on proper requirements and specifications when doing procurement on behalf of manufacturing.
  • FDA and EU GMP compliant laboratory equipment and IT system, also specifically in compliance with Part 11 compliance and requirements on audit trail.
  • The laboratory equipment​ and IT system​ were both installed and integrated into the existing IT infrastructure with minimum down-time.
  • All test and qualification activities were passed, acceptance criteria met, and the system and equipment was handed over to production.
  • IT O&M instructions were approved.
#Pharma #Installation #Qualification #OTC #IT #RiskAssessment

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Henrik Johanning

CEO & Senior Consultant
IT & Automation / GAMP, Project Management, Management Consulting, GMP, Regulatory Affairs, Training