A process validation report template is used by validation managers in the pharmaceutical manufacturing industry to properly document qualification protocol and ensure compliance with FDA regulations. This process validation report templates has been designed to make it easier for validation managers to perform equipment criticality and risk assessment, compare acceptance criteria against performance test results, and specify areas of deviation.
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Templateby SafetyCultureProcess Validation Protocol - Performance Qualification Template
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.
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Process Validation Protocol - Installation Qualification Template
An installation qualification template is used to complete the process validation protocol by properly documenting that the equipment/system is correctly installed, supplied as specified, and integrated in the manufacturing facility calibration and maintenance systems. This process validation protocol - installation qualification template contains components checklist to make it easier for protocol authors to specify component name, code no., function and area(s) of deviation, if any.
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Process Validation Protocol - Operational Qualification Template
An operational qualification template is used to complete the process validation protocol by recording all required data such as calibration equipment, training records, and user's manuals and indicating the results from control points, alarms, and outputs. Easily define specific challenges of the equipment/system like normal conditions and worst case situations with the use of this process validation protocol - operational qualification template.
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Process Validation Protocol - Equipment Qualification Template
An equipment qualification template is used to complete the process validation protocol by reporting the verification of the equipment/system final design against the user, functional, and/or design specifications. Use this process validation protocol - equipment qualification template to easily identify key items of equipment, utilities supply, and environmental requirements. Take/attach photos of all relevant equipment drawings such as mechanical drawings, electrical schematics, process and instrument drawings, etc.
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