What is a validation report?
A validation report is used to properly document process qualifications. You can also use a validation report checklist to ensure that your facility, machinery, and products are reliable, consistent, and compliant with regulations. A process validation template can be used in different industries, like pharmaceuticals, construction, food production, or operations.
You should document all this in a process validation report, especially in case of audits and inspections by authorities.
Table of contents:
1. What is in a process validation report?
2. How can you comply with your validation reports?
2.1. Focus on risks
2.2. Develop a master validation plan
2.3. Document thoroughly
2.4. Monitor continuously
3. Using digital validation report software
What is in a process validation report?
A good process validation checklist template should cover several areas. Include tasks and ask questions about each area so that your validation reports are the highest quality possible. Your template needs to include:
- Introduction
Briefly describe the process, the product, or your equipment; also address the requirements of each. Then, describe the impact of this process/product on other processes, documents, business partners, or similar. - Technical Information
In the next section, you should provide all technical information, including steps involved in the procedure and equipment involved. 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, 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. Make sure to define criteria for successful processes. - Documentation
In the last section, make a list of all the required documents, so you can complete them one by one. You can use a checklist to ensure there are no missing documents.
How can you comply with your validation reports?
Answering process validation questions is only a first step towards implementing process controls. There are four basic guidelines you should follow to ensure continued compliance.
Focus on risks
It’s a good idea to adopt a risk-based approach to control processes that you cannot verify. It can be helpful to analyze process risk according to the guidelines of the risk management standard ISO 14971, since that clearly details how risks can impact your productivity and products
Develop a master validation plan
Use a master validation plan as a roadmap for process validation. Master validation plans help you 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 simultaneously.
Document thoroughly
As with any regulatory process, documenting activities and results is mandatory when preparing for an audit. This includes documenting reasons why a company believes the processes do not warrant revalidation.
Monitor continuously
Even after process validation has been completed, companies are required to sufficiently monitor and control their validated processes to ensure that specified requirements continue to be met.
Using digital validation report software
Conducting process validations and meeting your compliance goals is easier when you have a digital validation reporting tool. With Lumiform’s desktop software, you can create checklists and evaluate any data collected. The app guides users through each stage of documentation, reducing the risk of quality loss, documentation errors and reputational damage.
Lumiform’s digital app makes it easier for you to comply with 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 your forms. Clean, transparent documentation helps you avoid high fines and:
- Gives you an overview of everything that happens on-site during process validation.
- Increases the efficiency of your processes validation, by helping your team and stakeholders communicate more efficiently and report incidents more quickly, you can resolve incidents up to 4 times faster than before.
- Saves time by automatically generating
data analyses and identifying areas that need your attention more quickly.
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