ISO/IEC 17025:2017 Compliant Cloud LIMS Software
Purpose-built for commercial testing and calibration laboratories to maintain quality management system controls across Clauses 6, 7, and 8 with automated audit trails.
Full structural mapping
Data integrity & audit trails
Automated bench guards on overdue calibration
Dual-mode scope & sequential ULR engine
DESIGNED TO SUPPORT INTERNATIONAL ACCREDITATION STANDARDS
How ExactLIMS Fulfills Clauses 6, 7, and 8 of ISO/IEC 17025
Assessors scrutinize objective evidence. Click each clause below to inspect the software mechanism, audit trail, and proof packet generated by ExactLIMS.
Clause-by-Clause Compliance Mapping
Equipment & Calibration Management
Standard Standard Implementation Spec
"The laboratory shall establish a calibration programme, monitor equipment performance, and safeguard against adjustments that could invalidate results."
Automated asset registry with calibration schedules, preventive maintenance (PM) timers, and dynamic bench guards that automatically lock out expired instruments from batch allocation.
NIST/NABL-traceable calibration certificates, daily balance verification logs, calibration curve coefficients, and automated out-of-service lockout states.
Explore Related Compliance Disciplines & Audit Resources
ExactLIMS provides specialized modules across Indian and international laboratory testing standards:
Satisfying Section 7.11: Control of Data & Information Management
Assessors pay close attention to Section 7.11, examining whether your software is validated, protected from unauthorized tampering, and backed up properly. ExactLIMS provides software architecture designed around ALCOA+ data integrity principles.
Validated Release & Software Qualification Dossier
ExactLIMS provides qualification documentation verifying calculation engines, access controls, and reporting templates for your accreditation dossier.
Cryptographic Immutable Audit Trails
Every result input, modification, parameter override, and supervisory approval is logged with user ID, before/after value, UTC timestamp, and justification.
Automated Geographic Cloud Backups & Disaster Recovery
Continuous point-in-time automated backups with 256-bit encryption in transit and at rest, satisfying accreditation disaster recovery requirements.
Data Integrity Enforcement
Attributable
Unique user credentials with e-signatures
Legible
Permanent digital storage; no manual scribble
Contemporaneous
Real-time time-stamping at entry point
Original
Direct instrument ingestion; zero transcription
Accurate
Automated formula calculation & rounding rules
Complete
All raw files, blanks & calibrations preserved
ISO/IEC 17025:2017 Assessment Readiness Checklist
A practical 25-point internal audit guide mapped to NABL and global accreditation standards. Verify your lab's data integrity, calibration controls, and reporting compliance before lead assessors arrive.
| ISO Clause | Accreditation Audit Focus Area | ExactLIMS Automation Status |
|---|---|---|
| 4.1 & 4.2 | Role-based access control safeguarding data confidentiality & impartiality | Fully Automated |
| 6.2 | Personnel training logs, analyst qualification, and blind sample competency checks | Fully Automated |
| 6.4 | Automated instrument calibration lockout preventing overdue asset use | Fully Automated |
| 6.5 | Metrological traceability to SI units via calibration certificate attachments | Fully Automated |
| 7.2 | Method lifecycle management (DRAFT → EFFECTIVE → SUPERSEDED) with locked SOP formulas | Fully Automated |
| 7.4 | Unique container barcode accessioning, cold storage logging & discard schedules | Fully Automated |
| 7.7 | Continuous Levey-Jennings control charts, Westgard rules, CRM blanks & duplicate checks | Fully Automated |
| 7.8 | Sequential Unique Lab Report (ULR) tracking with tamper-evident QR code authenticity | Fully Automated |
| 7.11 | Software validation, electronic audit trails, and backup integrity satisfying Section 7.11 | Fully Automated |
| 8.7 | Integrated Non-Conformance (NC) and CAPA workflow with 5-Why root cause analysis | Fully Automated |
Frequently Asked Questions About ISO/IEC 17025 Compliance
Detailed answers covering Section 7.11 data integrity, accredited vs. non-accredited scope tracking, measurement uncertainty, and calibration guards.
Pass Your Upcoming ISO/IEC 17025 Audit with Zero Critical Non-Conformances
From equipment calibration guards to method versioning and statistical Levey-Jennings charts, ExactLIMS automates your Quality Management System so your team can focus on analytical excellence.