Validation And Qualification Services

Infitrak qualification and validation services summarize what you want to accomplish, including enumeration and the explanation of control parameters. This includes a comprehensive array of elements that include:

• Protocol writing
• Protocol execution
• Report writing for Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ)

Planning how your qualifications will be performed includes testing parameters, equipment characteristics, and decision parameters as part of the acceptance criteria.

As well, each document includes all of the critical steps that need to be measured including the variability criteria and testing methods.Each Qualification protocol is reviewed with your team, and once approved, will be numbered, signed and dated.

These protocols include:

• Study objectives
• Team members, including their experience and responsibilities
• A list of the equipment to be qualified, including worst case and normal operating parameters
• IQ/OQ/PQ results and findings
• Calibration parameters for any equipment used in the qualification testing
• Critical process parameters, and respective tolerances
• Process flow diagrams
• Statistical tools used as part of the data analysis
• Narrative, graphical and tabular presentations to best display the findings and supporting information
• Study results and report approvals