Validation managers in the pharmaceutical industry use such a template for process validation to document everything properly. In this way, they ensure that the regulations are adhered to. This process validation report template is designed to make it easier for validation managers to perform equipment testing and risk assessment, compare acceptance criteria with performance test results, and define ranges of variation.
Directions:
1. Identify the influence of each tool on the product
2. Define its corresponding risk priority and attach suitable photos.
3. Define qualification protocol such as environmental demands, utility supply, SOPs ready, calibration devices, acceptance criteria vs. performance test results, and fields of variation.
4. Describe conclusions on the efficacy of the devices/system
5. Finish this template with digital signatures of the validation manager, head of quality assurance and production officer
Equipment Criticality & Risk Assessment
Mixing Tanks
Raw Material and Consumable Refrigerators and Freezers
Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.
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