Alternatives Tech provides full qualification services, including protocol writing, protocol execution and report writing for Installation, Operational and Performance Qualifications (IQ/OQ/PQ).
The IQ/OQ/PQ protocols are written plans indicating how the qualification will be performed, including the testing parameters, the equipment characteristics and decision parameters for acceptable results. The documents include all the critical steps that have to be measured, the variability acceptable limits and the equipments testing method.
The qualification protocols are a summary of what you wish to accomplish. All control parameters are enumerated and explanation on how the regrouped data is analyzed in order to verify their relevance. The approval by the validation team is also consigned. The qualification protocols are numbered, signed, dated, and include the following information:
- Objectives, objects and contents of the qualification study.
- Responsibilities, experience and team member of the qualification study.
- Qualification equipment’s needed list and their normal and worst case conditions of operation and parameters.
- IQ/OQ/PQ results and findings.
- Calibration parameters for the qualification testing equipment.
- Critical process parameters and their respective tolerances;.
- Process flow diagram.
- Statistical tools for data analysis.
- Document, graphics and matrix for data recording.
- Data presentation format, conclusion documentation and qualification study’s results and reports approvals.
