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cGMP Validation

VERSA’s validation experts can help you generate documentation for: System Impact Analysis (SIAs), Criticality Assessments (CAs), Preliminary Hazard Analysis (PHAs), Qualification Project Plans, Commissioning Plans, Risk Plans and Validation Protocols (VPs).  We can provide validation summary Packages for Installation Qualification (IQ) and Operational Qualification (OQ) results.

Actual procurement can be done by the client’s contract office, or by following the standards of the Qualification Package for Petroleum Refining Projects. Procurement also includes commercial evaluations, negotiations, purchase order placements, expediting, inspection, and shipping coordination.

VERSA can also assist with commercial specifications as needed, to ensure best bidding strategy. VERSA then analyzes the bids for the client, to ensure optimal selection based on technical qualifications, pricing and maintainability. We work with the client to ensure a life cycle perspective is used, such that the new asset is indeed not only fit for purpose, but best overall for the facility in the long run.

VERSA can work with either the client or the construction company to ensure all post-award activities are properly carried out, including expediting, factory work quality assurance, FAT, delivery logistics, and installation details.