The life sciences is a heavily regulated industry for obvious reasons: the drugs and devices a life sciences firm manufactures or distributes must be consistently safe and reliable for consumers. To ensure that happens, the FDA regulates life science firms according to regulations specified in 21CFR. Part of that regulation is validation of the software used by life sciences businesses.
In 21CFR part 11, the FDA mandates that life sciences firms must ensure and prove that their computerized systems related to good manufacturing practices (GMP) and other best practices specified by the FDA are consistently met.
FDA validation of software is proving that the computerized systems a business uses perform as expected and mandated. Here’s a quick overview of that FDA validation process, a process that applies to pharmaceutical companies, medical device manufacturers, CDMOs and other life sciences firms that use computer systems such as ERP.
Overview of the FDA Validation Process
Validating software to meet 21CFR part 11 of FDA requirements is all about testing and documenting systems to show they conform to GMP and the other GxP requirements (GxP is the overall term that encompasses all FDA-mandated best practices). This documentation includes functional requirements, traceability matrices, operational qualification, and functional test reports.
Risk Assessment. The first step is identifying functional software systems used by a life sciences business that are governed by GMP or other GxP regulations. Not all software used by a business must be validated—the FDA doesn’t care about financial accounting processes, for instance. So life science businesses must identify the systems that are regulated, and look at the risk probability of each GxP functional process to develop the proper testing strategy for it.
Requirements Traceability Matrix. All critical GMP and GxP requirements must be tested and documented. This testing needs to have traceability between specifications. So the business needs to develop a requirements traceability matrix as part of the FDA validation documentation.
User Requirements and Functional Specifications. Next, life sciences firms need a set of written policies in place that define the testing scope both for user requirements and functional specifications of the software that falls under GMP or other GxP mandates. Firms should set this scope before testing, and have it fully documented.
Master Validation Plan and Test Protocols. Part of preparing for the tests is defining how GxP and non-GxP functions impact the scope and process of testing. Prior to validation, a Master Validation Plan should be created that outlines testing strategy. A Test Protocol also should be designed that proves the computer software operates as intended. This protocol should explain how the tests will be conducted, as well as outline the risk priority of the affected functions being tested.
Testing for Expected Results. With plan and protocols in place, life sciences businesses then must carry out the full scope of defined tests to ensure that the software is properly configured and performs as expected in order to meet all FDA mandates.
Validation Summary Report. The crucial final piece of FDA validation for software is the documentation of the testing that was performed, both that which was executed successfully and tests that failed. To validate the system and prove that the software meets FDA mandates, all tests must be fully documented. Additionally, a post-testing review and report of validation must be created to prove FDA validation of the software.
Cutting the Cost of FDA Validation
Life science firms must validate their ERP system according to 21CFR part 11. There’s no way around it. But there’s a hard way and an easy way to validate.
The easy way is using a prepackaged ERP solution for life sciences that comes FDA validation-ready out of the box. This means that there is less time spent configuring the ERP system for proper validation, and less chance that the system will run into problems with FDA validation—the system already is configured for validation. Validation then becomes a formality and a task that is a lot less time- and money-intensive.
Working with an experienced ERP consultant during implementation also can ease the burden of FDA validation.
We understand GMP and how life sciences software should be configured to meet FDA mandates for quality, consistency, traceability and data collection. We’ve also helped numerous pharmaceutical, medical device and CDMOs implement ERP solutions and navigate the validation process.
So not only have we developed prepackaged solutions that ease the burden of validation, we also have a test-script library that represents the more prevalent functions in the manufacturing process for a life sciences company to help ensure that the system passes all validation tests.