Compliance is Non-Negotiable
Most of what a standard asks for is evidence. ErgoLIMS is built so that evidence accumulates while the work happens — and so that changing it later leaves a mark. Built around ISO/IEC 17025:2017 and 21 CFR Part 11, with the boundaries stated on each page.
A page per standard
What the platform does, which modules the accreditation pack switches on, and—on every one of them—what it does not do.
Quality managers preparing for accreditation or a surveillance visit, and lab directors deciding whether a LIMS will survive an assessor reading it.
Read the detailNABL-accredited labs and labs preparing their first application, in testing, calibration or medical disciplines.
Read the detailPharmaceutical, contract research and regulated manufacturing labs whose records may be inspected.
Read the detailFSSAI-notified and referral laboratories, and in-house QC labs at food manufacturers.
Read the detailBIS-recognised laboratories, and in-house labs at manufacturers holding a CM/L licence.
Read the detailISO/IEC 17025:2017 — Clause by Clause
Each clause below names the feature that holds its records. Coverage isn’t uniform — §7 and §8 go deepest, and the ISO 17025 page says where it stops.
General Requirements
Structural Requirements
Resource Requirements
Process Requirements
Management System
21 CFR Part 11 — Electronic Records & Signatures
FDA's gold standard for electronic records. Required for pharmaceutical and food labs operating under GMP.
Electronic Records
All entries timestamped, attributed, and stored immutably.
E-Signatures
Identity challenge with printed name, date, time, and meaning of signature.
Audit Trail
Captures WHO, WHEN, OLD VALUE, NEW VALUE, REASON for every change.
System Access Controls
Role-based permissions, session expiry, brute-force lockout.
Operational Controls
Authority checks prevent unauthorized result approval.
Record Protection
AES-256-GCM encryption at rest, soft-delete with recovery.
Immutable Audit Trails
The "Black Box" of your lab. Every click, edit, and deletion is recorded. Enforced by PostgreSQL triggers — the trail is written at the database layer, so it cannot be edited away by the application. Who changed result 10.5 to 10.4? Why? When? Captured instantly.
"event": "RESULT_MODIFIED",
"old_val": 10.5, "new_val": 10.4,
"user": "analyst_01",
"reason": "Transcription error corrected",
"timestamp": "2024-10-27T10:30:00Z"
Strict RBAC
Analysts enter data. HODs review. Lab Directors sign off. Strict segregation of duties — no analyst can approve their own result.
Data Sovereignty
Your data belongs to you. AWS Mumbai Region for SaaS (Indian data residency). On-premise available for complete isolation. AES-256-GCM encryption at rest.
Active Non-Conformance Prevention
Most LIMS just record errors. ErgoLIMS prevents them. The system physically blocks result entry if:
- Selected instrument calibration is expired
- Reagent batch is past expiry date (FEFO enforced)
- Analyst is not trained/authorized for this specific test method
- OOS result lacks mandatory deviation remark
GDPR & India DPDP — built on, not bolted on
The infrastructure a privacy programme depends on — who can see what, how long data is kept, and proof nothing was altered afterwards — ships today. The dedicated console for handling individual subject requests is on the roadmap, and is labelled as such below rather than folded into the rest.