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Computer System Validation
Computer System Validation (CSV) is often referred to as software validation. Regulated companies perform validation projects to prove that their software or system is performing the way it is supposed to work, and not performing in ways that it isn’t intended to work.
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What Is Computer System Validation?

The process of software validation ensures that the system fits its intended use and functions as it should. Computer system validation (CSV) for laboratory informatics is essential because regulated businesses must ensure the safety of their products for consumers, and their laboratory informatics systems (LIMS, ELN, CDS) are an integral part of that. Given its importance, validation tends to be seen as confusing and challenging to execute correctly.
No discussion of computer systems validation is complete without an overview of the legislation around it. In the United States, the Food and Drug Administration (FDA) regulates specific industries that directly impact consumer health, including pharmaceuticals, cosmetics, and food and beverage. These industries have an added responsibility to ensure their products are safe and their data are secure.

FDA CFR Part 11

The relevant legislation addressing aspects of computer systems validation in the United States comes from the Code of Federal Regulations (CFR), most specifically 21 CFR Part 11 (Part 11), dealing with electronic records and signatures. Similar government agencies and regulations apply in other countries as well.
Part 11 mandates the requirements for electronic records and signatures to be considered accurate, reliable, readily retrievable, and secure, to replace paper records and handwritten signatures legally. Validating your computer system is the primary means of determining that electronic records and signatures can be used in this way.

The Validation Process

Validation can take many shapes during the computer system life cycle, depending on whether it is a new implementation or an upgrade to an existing system. For new systems that the user hopes can solve a current problem, validation happens from the ground up. For an existing system that needs an upgrade or is expanding the scope of its intended use, the need is to keep the system in a validated state by testing the new capabilities before releasing them into production use. The validation process ends when a system is retired and its data are successfully migrated to a new system or archived. The figure below shows how validation supports the project life cycle.

The Validation Master Plan

Validation master plan guides you through the validation process and becomes a sort of a check-off list to ensure that everything happens as it should. Once you’ve assessed the As-Is state of your system, the validation master plan encompasses all the other steps you’ll take to ensure your system is validated in its current state and fit for its intended use.
The validation master plan should account for requirements gathering, a functional risk assessment, a trace matrix, IQ OQ PQ protocols and testing, and change control procedures with periodic reviews. Each part of the validation master plan is executed in a defined order. Your requirements should be complete and the risk assessment done before you move on to developing the trace matrix and then doing the testing. This way, you minimize the risk of having to go back and develop new test cases late in the process.

IQ/OQ/PQ testing

IQ/OQ/PQ testing is arguably an essential part of the validation process. Successful completion of the testing will verify that your system functions as intended and is fit for its intended use in your environment. It is best practice to approve your user requirements and functional specifications before testing to avoid scope creep and possible re-testing. The people writing and executing your IQ/OQ/PQ testing should be thoroughly familiar with your lab informatics system (LIMS, ELN, CDS) and your intended use. If your in-house staff does not have the bandwidth or experience for proper testing, you should work with qualified CSV consultants, like CSols, who have the requisite experience with your informatics systems.
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