Implementing a Laboratory Information Management System (LIMS) can feel like walking a tightrope. The challenge is knowing where to draw the line during the pilot phase. Implement too little functionality, and the system may seem like more trouble than it’s worth. Add too much, and the project can spiral out of control, delaying your launch. Striking the right balance is key so you deliver clear organizational benefits within a realistic timeline.
Start with the Right Goal
A common first milestone for LIMS implementation is generating a Certificate of Analysis (CofA) report. But achieving this goal requires significant groundwork:
- Define testing and acceptance criteria for each product.
- Develop sampling plans and workflows for sample accessioning and submission.
- Establish analytical batching, including batch review and approval processes.
Only after these steps can you produce a CofA report. It’s a significant undertaking that demands focus and commitment from the team.
Beware of Scope Creep
During implementation, you may be tempted to include additional features early on—this is the infamous “scope creep.” While it’s natural to want a robust system from the start, keeping your scope focused on a discrete, end-to-end process, such as CofA generation, increases your chances of delivering on time and with impact.
We advise clients to approach the pilot phase laterally, covering business processes end-to-end while postponing deeper feature sets to future phases. Starting with a necessary output, like the CofA, ensures your system delivers immediate value while creating a foundation for future enhancements.
What Comes Next?
Once your LIMS is live, you’ll see opportunities to expand its capabilities. Here are two common extensions that deliver significant value:
- Reagent Management
Digitalizing reagent management is often a natural next step. Most biotech labs rely on paper forms for solution prep and handwritten labels for reagents—practices that are resource-intensive and prone to error. Moving reagent management to a digital platform enables:- System-generated labels.
- Expiry tracking.
- Automated lab clearance reports.
These features simplify compliance with regulations like 21 CFR Part 211, Subpart I – Laboratory Controls, and reduce the burden on lab staff.
- Laboratory Trending
Another valuable enhancement is laboratory trending, which supports compliance with regulations such as ICH Q10 – Pharmaceutical Quality System and ICH Q7 – Good Manufacturing Practices. By tracking assay controls and reference standards over time, you can:- Identify trends that may indicate assays moving out of compliance.
- Avoid deviations and costly investigations.
- Simplify Annual Quality Reviews (AQRs), reducing the time and effort spent compiling and analyzing data.
Align Your LIMS with Organizational Goals
Whether you’re expanding into reagent management, laboratory trending, or another area, align your LIMS roadmap with your organization’s key objectives—eliminating bottlenecks, addressing audit findings, or meeting corrective action plans.
A flexible LIMS product and strong vendor support are critical to ensuring your system evolves with your needs and continues to deliver value.
If you’re exploring LIMS solutions, contact BioIT Solutions at sales@bioit.com. We’ve helped dozens of emerging biotech companies digitize their lab processes, and we’re ready to help you, too.
For more insights and updates, don’t forget to follow us on LinkedIn!
