Datamine LIMS Compliance with ISO/IEC 17025:2017 – Clause 7.11.2

Validation of Laboratory Information Management Systems

Overview

Datamine LIMS solutions are commercial off-the-shelf (COTS) laboratory information management systems designed specifically for mining and analytical laboratories. In alignment with ISO/IEC 17025:2017 Clause 7.11.2, these systems support laboratories in ensuring that software used for the collection, processing, recording, reporting, storage, and retrieval of data is appropriately validated prior to use and after any changes. As outlined in ISO 17025, commercially available software used within its intended scope can be considered inherently validated; however, laboratories remain responsible for validating their configured implementation within their own operational environment.

Datamine Validation Approach

To support compliance, Datamine follows a structured implementation and validation process that ensures the system functions correctly within each laboratory’s specific configuration.

Initial System Configuration

  • A dedicated database/environment is configured to reflect:
    • Laboratory workflows
    • Analytical methods
    • Quality control requirements
    • Reporting formats
  • All configuration is documented and reviewed by laboratory stakeholders prior to testing.

Functional Validation Testing

Datamine performs both remote and onsite validation testing in collaboration with the laboratory to confirm that the system performs as intended.

Remote Testing Phase

  • Conducted during configuration and early deployment
  • Includes:
    • Verification of workflows (sample registration → analysis → reporting)
    • Validation of calculations and QC logic
    • Testing of instrument interfaces and data imports
    • Review of reporting outputs and formats

This phase allows early identification and correction of issues prior to onsite validation.

Onsite Validation & User Acceptance Testing (UAT)

  • Conducted on the laboratory environment
  • Includes:
    • End-to-end testing using real or representative samples
    • Verification of instrument integrations under operational conditions
    • Validation of user roles, permissions, and data integrity
    • Confirmation of reporting outputs against laboratory requirements

Laboratory personnel actively participate in this phase to confirm that the system meets operational and quality expectations.

Issue Resolution and System Refinement

Any discrepancies or issues identified during testing are:

  • Logged and tracked
  • Corrected by the Datamine team
  • Re-tested to confirm resolution

This iterative process ensures that all system components function correctly prior to production use.

Change Management and Revalidation

In accordance with Clause 7.11.2, any changes to the system are controlled through a structured process:

  • All changes (e.g., configuration updates, new methods, report modifications, software updates) are:
    • Authorised by the laboratory
    • Tested and validated prior to implementation

Where applicable, testing may include:

  • Regression testing of existing workflows
  • Validation of new or modified functionality
  • Review and approval by laboratory personnel

Conclusion

Through a combination of:

  • Structured configuration
  • Remote and onsite validation testing
  • Controlled change management
  • Documented verification processes

Datamine LIMS supports laboratories in meeting the requirements of ISO/IEC 17025:2017 Clause 7.11.2, ensuring that the system is fit for purpose, reliable, and properly validated within the laboratory environment.