Validation

Case History
Retrospective Validation Services


Project
Provide remedial validation services for medical gas production facilities. Services include the development of System Specification Document, IQ / OQ protocols, and execution of the IQ and OQ protocols.

Architecture

• Performed a gap analysis to assess existing design documents, computer system specification documentation, and qualification protocols for cGMP compliance.
• Developed current revalidation plan to augment earlier validation efforts.
• Created a detailed System Specification Document for the computer control system (PLC and HMI).
• Developed and executed IQ / OQ test protocols.

Project Scope
Provided remedial validation services for existing operating medical gas facilities. Services included the development of a system specification document and associated IQ / OQ Test Protocols. The IQ / OQ test protocols were subsequently executed with support from ACE engineers.

Status
Revalidation summary reports were given to the FDA for the first plant. The FDA has given positive feedback at this stage. Six ACE engineers are currently working on the third and fourth plants to establish the required documentation for this revalidation effort.