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.

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.