Why LIMS Validation is Essential for Laboratory Success
If you have been following Third Wave Analytics, you probably already know how important LIMS validation is for any lab. You also likely know that in addition to providing Lockbox Laboratory Information Management System, the most innovative, user-friendly LIMS on the market, we are deeply committed to ensuring that its products and services meet your compliance needs.
Customers often ask us, “Why do I need to validate my computerized LIMS?” This question can be answered in many ways. Often, people think that LIMS software validation is only needed if they have a clinical lab, an FDA-regulated medical device, or a pharmaceutical company. However, validation is a best practice across the board, even if you are a pure research organization. With a computer system validation plan however, it’s an easily manageable process that can yield numerous benefits.
What is LIMS Validation?
All Laboratory Information Management Systems (LIMS) need to conform to a certain set of FDA standards. LIMS software validation is the process of auditing the entire computer system to ensure that it meets those guidelines. The process can be done manually, but is best automated, as it can be time and resource-intensive. The FDA can audit any lab to make sure its laboratory information system meets specifications, so at its core LIMS validation exists to ensure that those specifications are being met. There are some other, perhaps unexpected, benefits to LIMS software validation that make it even more important, however.
Why Validate My Laboratory Information Management System?
Some of the most important reasons for ensuring that your LIMS is tested, verified, and validated for use in your production environment prior to release are:
- Fitness for Intended Use: Ensuring that your LIMS has been configured to your user requirements prior to release is far easier than backtracking! If you release an untested system to your user base, only to find out that it didn’t meet expectations for intended use, you will waste valuable time and resources.
- Monetary Savings: Adding new features or changing configuration in your LIMS is more cost-effective if done prior to release. Release without proper testing can mean loss of revenue due to work stoppage in order to make post-release updates.
- Traceability: A key part of computer systems verification and validation is traceability. By having a traceability matrix that matches each requirement and specification to a test case, you can be certain that all technical risks and requirements have been adequately addressed.
- Audit-readiness: Nothing is more stressful than scrambling at the last minute to reverse-engineer your documentation. You can’t predict an audit. Maybe the product you are researching will turn into the next commercial blockbuster. Or, perhaps you think you will be going for a certification like CLIA, CAP, or ISO down the line. By ensuring that the systems you use to track and produce your work are properly documented and validated from the beginning, you have a documentation trail that will stand up to an audit when the time comes.
Full Validation – the Lockbox LIMS Difference
Luckily, our Lockbox LIMS software makes the laboratory information system validation procedure simple. At Third Wave, we use a GAMP 5 (Good Automated Manufacturing Practice), risk-based approach to verify and regression test every component of our Lockbox managed package (the base configuration of Lockbox LIMS). All the tests of our managed package are documented, recorded, and retained as per Third Wave’s “Control of Quality Records” policy. We refer to these tests when we configure your Lockbox. Once your Lockbox LIMS is configured, we create test cases just for your configuration to ensure that it is working correctly prior to release to your organization.
If you add our verification services and validation guidance to your contract, we can provide all the tools you need to document your system, including:
- User requirements
- Functional requirements
- Design specifications
- Assessment of technical risks
- Documentation of customizations, such as special fields, rules, triggers, and Apex code
- Verification test cases and results
- Traceability matrix of tests to requirements, risks, and other specifications (as per your statement of work)
- Unexecuted tests cases that you can use for user acceptance testing, or to modify for validation in your own environment
- Verification test summary report, including test metrics
- Software issue and resolution reports (if applicable)
We can also create validation plans and provide guidance on validation best practices to ensure that your Lockbox Laboratory Information Management System is validated for intended use in your environment. As one of the top LIMS vendors on the market, we’re here to help with the entire process. LIMS software validation is critical, but it doesn’t have to be complicated. Please ask our marketing team for details on how to build these services into your Lockbox LIMS configuration plan, or for more details, you can request a referral to our Quality Assurance experts.