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Validation Report

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

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What is a validation report?

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.

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

This article deals with:

1. Content of a validation report

2. 4 tips to ensure compliance with the validation

3. Advantages of digital validation report templates

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Content of a Validation Plan

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.

  1. 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.
  2. Technical Information
    In the next section, you should provide all technical information, including the procedure from a technical point of view and the 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.

  3. 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.
  4. 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.

4 tips to ensure compliance with the validation

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.

Advantages of digital validation report templates

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.

  • Get an overview of everything that happens on-site during process validation.
  • Increase the efficiency of your processes validation: 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.
  • Validation reports are created automatically so that you save the complete postprocessing.
  • Save time by analyzing all data more easily and identifying areas that need your attention more quickly.
  • 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.

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