LIMS Compliance — ISO 17025, GLP, GMP & 21 CFR Part 11
An accreditation audit doesn't care how good your testing is if your records can't prove it. LIMS compliance means the software itself is built around the exact checklist your accreditation body audits against — ISO/IEC 17025, NABL, GLP, GMP or FDA 21 CFR Part 11 — not retrofitted after the fact.
See A Live LIMS Demo First
Audit trail, e-signatures, data integrity controls — sab live demo mein dekho, 5 minute mein.
What Compliance-Ready LIMS Actually Requires
- Full audit trail — every record change logged with user, timestamp and reason
- Electronic signatures — 21 CFR Part 11-style reviewer/approver sign-off
- Data integrity controls — no silent edits, no unlogged deletions
- Role-based access — analyst, reviewer and approver permissions kept separate
- Calibration & equipment records — instrument calibration due dates and history logged
- Inter-lab comparison & proficiency testing records — for ISO 17025 accreditation
- NABL / ISO 17025-format reporting — reports generated exactly how auditors expect them
- Document & SOP version control — GLP/GMP-required document management
Why This Matters More Than Features
Plenty of LIMS vendors sell feature lists. Very few actually understand what an NABL inspector or an FDA auditor looks for in an audit trail. We already run a live NABL LIMS platform in production, and we build the same compliance-first architecture into every LIMS — see our full LIMS software page or the wider compliance software suite covering NABL, NABH, BIS and QCI.
Frequently Asked Questions
What does data integrity mean in a LIMS?
Data integrity means every record — sample, result, calibration or approval — is accurate, attributable, and cannot be silently altered or deleted, with a complete audit trail of any change.
Is your LIMS ready for a NABL or FDA audit?
Yes. Our LIMS is built around ISO/IEC 17025, GLP, GMP and 21 CFR Part 11 principles, with full audit trails and electronic signatures designed for exactly this kind of scrutiny.
What is the difference between GLP and GMP compliance in a LIMS?
GLP (Good Laboratory Practice) governs non-clinical safety testing and research data integrity, while GMP (Good Manufacturing Practice) governs pharmaceutical and manufacturing quality processes — both require audit trails and e-signatures, which we build into every compliance LIMS.
Can the LIMS support inter-lab comparison and proficiency testing?
Yes, inter-lab comparison and proficiency testing records are supported and reportable — a standard NABL/ISO 17025 accreditation requirement.