Compliance is Non-Negotiable
ErgoLIMS doesn't just "support" standards — it enforces them. Built clause-by-clause on ISO/IEC 17025:2017 and 21 CFR Part 11. Every feature maps to a specific regulatory requirement.
ISO/IEC 17025:2017 — Clause by Clause
Every section of the standard maps to a real feature in the platform. This isn't a checklist — it's the architecture.
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. Backed by ClickHouse — a column-store built for high-speed audit queries at scale. 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 Ready
Built-in data subject management. Labs serving EU clients or complying with India's Digital Personal Data Protection Act can manage consent, right-to-erasure, and data export workflows directly from the platform.