Process validation protocol - performance qualification template checklist
A performance qualification template is used to complete the process validation protocol by detailing how the equipment::System is continuously meeting performance criteria for routine use in commercial production. this process validation protocol - performance qualification template describes a sample objective, scope, and responsibility to make it easier for validation managers to accurately proceed with the equipment::System run. evaluate the acceptance criteria and performance test results, provide conclusions on the validity of the equipment::System, and gain departmental and quality assurance approval with the use of this template.
What does this form include?
This form contains 15 sections:
To determine that the equipment/system perform as intended by repeatedly running the system on its in
To be performed after the Installation and Operational Qualification have been completed and approved
Person responsible for operating the equipment or system will perform the qualification and record th
Select all that apply
Evaluation
- Perform all required calculations and statistical analyses
Criteria
Results
Date Study Initiated Date
Date Completed Date
Observations Made/Problems Encountered
Do results meet acceptance criteria?
Conclusions on the validity of the equipment/system
Protocol Author & Signature
Departmental Approval by
Quality Assurance Approval by
Use this template