Case Study: Developing a Custom LIMS Module for a Pharmaceutical Laboratory

Client Industry Pharmaceutical Mfg.
Critical Gap Stability Testing Workflow
Solution Bespoke LIMS Module
Compliance Scope FDA / 21 CFR Part 11
Schematic of custom-developed LIMS Stability Module for Pharmaceutical QC

Figure 1: Digital workflow orchestration – Seamlessly extending core LIMS functionality for specialized Pharma protocols.

The “Shadow Data” Risk

Rigid, out-of-the-box LIMS solutions often force scientific teams into manual Excel workarounds for complex stability studies. This “shadow data” creates massive Regulatory Compliance Risks and consumes over 15 hours of manual reconciliation time per week.

The NRV Solution

NRV Lab Informatics utilized Advanced SSL Scripting and API integration to build a native Stability Management Module. This solution automated sample scheduling, triggers, and reporting while ensuring all data remained within the audited LIMS environment.

Data Integrity & ALCOA+ Framework

Our custom engineering ensures that every extended feature adheres to the strictest global regulatory standards.

  • Standard: 21 CFR Part 11
  • Integrity: Audit Trail Preservation
  • Security: Digital Signature Workflows
  • Reporting: Validated Automated Reports
100% LIMS Adoption (Zero Excel)
15+ Hrs Saved per Analyst/Week
Zero Compliance Deviations

Does Your LIMS Match Your Science?

Don’t let software limitations compromise your data integrity. Our architects specialize in unlocking the potential of StarLIMS and LabWare for complex pharmaceutical workflows.

Consult a Development Specialist
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