The emergence of LIMS and other informatics tools have irrevocably changed the way labs manage data. As LIMS’ role has become more prominent, compliance and validation have grown increasingly complex.
The right LIMS can help labs bring everything together – from the lab task workflows, data compliance, instrument integration and communication to data generation, collection, analysis, reporting and delivery.
Validation: Vital for Compliance…and Data Integrity
For many labs – especially in the life sciences and biobanking sectors, but also in most research, manufacturing, or environmental testing labs – validation is the lynchpin to making everything work together. Without it, compliance can’t happen, and data integrity becomes a question mark. This leads to a decrease in confidence with results, which consequently impacts analysis and decision-making.
To prevent this, LIMS – like virtually all laboratory systems – must undergo QC/QA checks, or ‘validation.’ Validation is performed to answer one simple question: is the software performing in a manner for which it was designed? In other words, is it doing what it’s supposed to do?
LIMS validation ensures that the entire system:
- has been properly tested
- incorporates required controls
- maintains – and will continue to maintain – data integrity.
Laboratories must establish protocols and standards for the validation process and associated documentation.
Validated LIMS Out of the Box? Proceed with Caution.
It is important to remember that although commercial LIMS vendors perform initial internal system testing, the system must be validated by the purchasing customer in their intended operating environment, and on their own products. Additional validation must be performed whenever the customer, vendor or a third-party modifies or customizes the LIMS.
Validation – Simplifying Future Troubleshooting
Proper validation – whether of a LIMS or any other lab system or instrument – is necessary for labs to remain in compliance with regulatory bodies. But validation has another, secondary benefit – it provides thorough documentation on the LIMS system, which is a critical tool for any future problem troubleshooting or modifications you need.
Key LIMS Validation Challenges
One of the biggest challenges we typically encounter with LIMS validation involves a poorly-defined or weak validation team. Among the complexities of a project, defining the proper team to be involved in the LIMS validation is absolutely critical – and there are probably more people who should be involved in the process than you think!
R.D. McDowall referenced the breadth and diversity of stakeholders in a section at LabAutopedia headlined Validation Roles and Responsibilities for a LIMS Project. He listed senior management, laboratory management, laboratory users, the LIMS project manager, QA, IT, data users & sample providers, internal compliance, the LIMS provider, external consultants and more. Other sources have expanded the list to include configuration managers, developers, SMEs, etc.
Obviously, the team will be as large or small as it needs to be, depending on each particular user’s set of circumstances, objectives, project scale, etc. It is, however, an important consideration, and team leaders are encouraged to consider the range of stakeholders involved in their own organizations.
Validation – “Just Something that’s Happening Over There”
Once the team has been put in place, a consistent commitment and investment of time becomes the foremost challenge your organization will face. Most of the validation’s stakeholders have other tasks and responsibilities. Failure to take their workloads into consideration when developing a validation plan can have a detrimental impact on your organization.
The most obvious impact?
Delays due to de-prioritization of the project, in which validation takes a back seat to the routine tasks of team members.
Aligning with LIMS Validation Best Practices
Done right, validation services help you meet your quality & compliance expectations – and can reduce the pain associated with the complicated process of validation. Many organizations choose third-party validation services due to their experience, as well as their knowledge of LIMS validation best practices.
Best practices, however, often means different things to different labs in dissimilar industries. Some platforms address this by broadening their ability to conform to various industry standards.
At LabVantage for example, one of our core objectives with the LIMS has been to ensure that our validation methodologies & deliverables are fully-aligned with as broad a range of industry standards and best practices as possible. Some of these standards includes:
· GAMP 5
· IEEE Standard 1012 System and Software Verification and Validation
· 21 CFR Parts 11, 58, 210, 211, 820
· ASTM E1578 Standard Guide for Laboratory Informatics
· ISO 17025
· World Health Organization Validation of Computerized Systems
· MHRA GxP Data Integrity Definitions and Guidance for Industry.
Broadening and continuously updating our standards alignment has improved the software validation process for customers. This ensures compliance while decreasing what could be an otherwise cumbersome validation process.
Don’t Skimp on Validation!
Validating a LIMS is important – regardless of whether an organization is subject to regulatory requirements. It serves to confirm the system is properly performing sample management and yielding accurate business or research insights.