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      How to document configuration changes to maintain a validated calibration database.

      Learn how Calibration.com automatically records configuration changes, maintains an audit trail, and ensures compliance for regulated industries like biomedical and pharmaceuticals.

      Tip Tuesday: Configuration Changes Utility – Part Two: Documentation

      Introduction:
      Hello, I'm Walter Nowocen, the Life Sciences Product Manager for IndySoft. Welcome to today’s Tip Tuesday, where we’ll continue our discussion on the Configuration Changes Utility, focusing on documentation.

      Last August, we introduced the Configuration Changes Utility, which allows Calibration.com software to automatically record all changes across ten configuration areas as an electronic record. This is especially important for regulated industries like biomedical, where maintaining a validated calibration database is crucial. A validated state includes:

      • An effective audit trail of configuration change revision levels.
      • Objective evidence of robust configuration change testing.

      In Part One of this series, we covered revision level audit trails. Today, in Part Two, we’ll focus on documenting robust testing as part of maintaining an effective validated state.

      Overview of Today’s Session

      We’ll walk through the following:

      1. A Change Control Document Template – A structured way to document changes.
      2. An Example of an Event Configuration Change – Demonstrating the Configuration Change Utility.
      3. A Completed Change Control Form – Including an attached testing script.

      Change Control Document Template

      The Change Control Document consists of four sections:

      1. Change Request (Green Section) – Contains contact details, a description of the change, the reason for the change, and its priority (Critical, Urgent, or Routine).
      2. Change Request Review (Purple Section) – Determines whether the rationale is valid, assesses the revision level (e.g., Revision 1 → Revision 2), classifies risk (High, Medium, or Low), and documents the testing method.
      3. Change Details (Pink Section) – Includes test results (Pass, Limited Pass with Accepted Deviations, or Fail), along with comments and an attached testing script.
      4. Completion & Approval (Orange Section) – Final approval and execution sign-offs.

      Example: Event Configuration Change

      Now, let's walk through an actual event configuration change.

      Step 1: Making the Change in Workflow Configuration

      In Calibration.com, I recently modified a Print Label Event to add a new label size option. To demonstrate:

      1. Open the Workflow Configuration Module.
      2. Locate the Print Label Event.
      3. Navigate to Tab 17, which contains the pull-down list of label size choices.
      4. Add a new 1.5-inch label size option to the list.
      5. Save the changes.

      This completes the execution of the configuration change.

      Step 2: Reviewing the Automatic Audit Trail

      Next, we’ll use the Configuration Changes Utility to review the automatic audit trail.

      1. Open the Monitoring Section and select Configuration Changes Utility.
      2. Locate the Print Label Event change from yesterday’s Tip Tuesday planning session.
      3. The audit log confirms:
        • Revision Level Change: 1 → 2
        • Action Taken: Added a new 1.5-inch label size option.
        • User Information: Shows who made the change.
        • Software & Database Version Details.

      This automated tracking ensures that revision levels are documented for compliance.

      Step 3: Completing the Change Control Form

      Now, let's review the finalized Change Control Form with the attached testing script.

      Summary of the Change Control Form

      • Change Request:

        • Description: Added a 1.5-inch calibration label size to Print Label Events.
        • Rationale: A new manufacturing test console required a new label size.
        • Priority: Routine (straightforward modification).

      • Review & Approval:

        • Change Level: Revision 1 → Revision 2.
        • Risk Level: Medium (impacts processes but not product quality).
        • Testing Method: Unscripted (for medium risk).

      • Testing & Sign-Offs:

        • Result: Fully Passed – The test script confirmed functionality without issues.
        • Approvals: Signed by the implementer (me) and my manager.

      Step 4: Reviewing the Testing Script

      The Testing Script follows a structured format:

      1. Expected vs. Actual Results – Validates that changes work as intended.
      2. Objective Evidence (Screenshots & Data Logs) – Required for FDA compliance.
      3. Final Verification & Sign-Offs – Confirms that the print label update functions correctly.

      Conclusion

      Tracking configuration changes is challenging and not a standard feature in many calibration software solutions. Today, we demonstrated how Calibration.com’s Configuration Changes Utility:
      ✅ Automatically tracks revision levels.
      ✅ Provides a structured Change Control Template.
      ✅ Ensures compliance with FDA validation requirements.

      If you’d like a copy of the Change Control Document Template, email me with your contact information, and I’ll send it over.

      Thank you for attending this Tip Tuesday! Have a great day!