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A validation report is used to properly document process qualifications. You can also use a validation report checklist to evaluate whether any plant, machinery, products, etc. are reliable and consistent. That way, you can guarantee that your products have a high quality and comply with regulations. A process validation template can be used in different areas, for example in the pharmaceutical industry, in the building industry, in food production or in operational or installation processes.
A good process validation checklist template should cover the areas listed below. Add tasks and ask questions about each area in order to have a high-quality validation at the end.
Be as specific as possible and include the overall validation approach based on previous studies and data.
Even if you were able to answer the process validation questions satisfactorily, compliance is not assured. There are four basic guidelines you should follow to ensure continued compliance.
TIP 1: Focus the validation approach on risk
It is recommended that companies adopt a risk-based approach to control processes that cannot be verified. It can be helpful to analyze process risk according to the guidelines of the risk management standard ISO 14971, as it is essential to understand the impact of risk on manufacturing processes and specifications, especially for essential design deliverables.
TIP 2: Develop master validation plan
It is advisable to develop a master validation plan to help you develop a roadmap for validation. It can be used to determine what needs to be done, how it will be done, and who will do it. This is especially important when multiple processes and process validations are performed concurrently.
TIP 3: Document thoroughly
As with any regulatory process, documenting activities and results is a prerequisite for preparing for an audit. This includes documenting reasons why a company believes the processes do not warrant revalidation.
TIP 4: Monitor continuously
Even after process validation has been completed, companies are required to establish sufficient monitoring and control of the validated processes to ensure that the specified requirements can be met on an ongoing basis.
With digital validation report templates, you can easily perform any kind of process validation with a mobile device - online and offline. With Lumiform's desktop software you can create checklists and evaluate the data collected in the field. The app guides users through all documentation processes. This significantly reduces the risk of quality loss, documentation errors and damage to your reputation, and helps you better comply with regulations.
Lumiform's digital app makes it easier for you to comply with the ever-increasing legal requirements for process documentation. You can update the validation report checklists at any time and all stakeholders can immediately access the latest version of the forms. Clean, transparent documentation helps you avoid high fines.