Validation Report

Underpin your validation plan with a template that continuously strengthens confidence in your manufacturing process.

Go paperless, conduct inspections easily and solve issues quicker with your teammates.

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Process Validation Report Template

Such a template is used in the pharmaceutical industry to document everything properly.

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Process Validation Protocol - Equipment Qualification Template

Use this template to report the verifying of the equipment/system final design.

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Process Validation Protocol - Installation Qualification Template

Use this template to complete your installation validation plan.

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Process Validation Protocol - Operational Qualification Template

Use this template to complete the process validation protocol for an operational qualification.

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What is a Validation Plan Checklist?


A validation plan is used to properly document process qualifications. You can also use a validation plan 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.

You will need a process validation protocol, especially for audits and inspections by the authorities.


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.



This article deals with:


1. Content of a Validation Plan Checklist


2. Advantages of a Digital Validation Report



content of a Validation Plan Checklist


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.



Introduction


Start your process validation protocols by briefly describing the process, the product or your equipment, also address the requirements. Then describe the impact of this process/product on other processes, documents, business partners or else.


Technical Information


In the next section, you should provide all technical information, including the procedure from a technical point of view and technical equipment you use. You may need to check some things before you do this.

Be as specific as possible and include the overall validation approach based on previous studies and data.


Tests


In this section of your checklist, you should record the results of your tests and your validation strategy. For example, perform process tests or internal controls to have a good risk analysis ready. Also take the prescribed acceptance criteria into account.


Documentation of the validation


In the last section, make a list of all the required documents, which you can check off one by one. With a checklist, you will get a better overview of outstanding or missing documents.



Advantages of a Digital Validation Report



Why digital?


With a digital checklist, you can easily perform any kind of quality and safety inspection by tablet or smartphone - online or offline. With Lumiform's desktop software you can create checklists and evaluate the data collected in the field. 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 by using the mobile app to document via smartphone or tablet and to be guided by the system through all documentation processes. Clean, transparent documentation helps you avoid high fines. The easiest way to do this is with a digital solution like Lumiform.



Digitize checklists and internal processes with Lumiform:


Lumiform is a powerful checklist app for audits and inspections. The mobile app helps manufacturing engineers, validation managers and quality assurance personnel properly document a process validation upon submission, monitor processes for consistent product quality and promote continuous confidence in the manufacturing process.


With Lumiform's mobile app you can:


  • Do your process validation with a mobile device.

  • Capture photo evidence for the validation plan.

  • Observe differences within results from performance tests within the app.

  • Generate a report and share it with members of your organization after process validation using the automated template.

  • Use Lumiform for free. Benefit from the advantages of a premium account. Compare the price lists.

Advantages:


  • Generate real-time data via internal processes. This makes quality and safety measurable and you can use the data to continuously optimize processes.

  • Get an overview of everything that happens on-site.

  • Reports are created automatically so that you save the complete postprocessing.

  • Increase the efficiency of your internal processes: By communicating more efficiently within the team, with third parties and with management, and by reporting incidents more quickly, you can resolve incidents up to 4 times faster than before.

  • Save time by analyzing all data more easily and identifying areas that need your attention more quickly.

  • Continuous improvement of quality and safety: With the flexible checklist construction kit you can constantly optimize internal tests and processes. The Lumiform guides the examiner through the exam; no training is required.

  • The very simple operation offers no margin for error for inspectors on site. Lumiform offers less complexity in documenting or filling out checklists than complicated paper or Excel lists.