Overview

Software validation is the process of ensuring that a software system meets its intended use and performs reliably within its operational environment. For regulated industries, validation provides documented evidence that the system consistently produces results that meet predetermined specifications and compliance requirements. Validation of Sample Manager/LabKey LIMS is an optional add-on to Sample Manager Professional Edition or LabKey LIMS and performed by our third-party partner, CompliancePath. The Validation Pack is updated with each ESR release of Sample Manager/LabKey LIMS and includes Installation Qualification (IQ) and Operational Qualification (OQ) documentation.

This page will be updated with the most recent version of the release schedule.

25.11.8 Sample Manager/LabKey LIMS Validated Release Schedule

Please refer to this schedule for the 25.11.8 validated release of Sample Manager/LabKey LIMS.

• Week of January 19: Upgrade test environments to early access release of 25.11.8
• Late January/Early February: Validation Pack Target Released
• TBD: Upgrade of production environments to 25.11.8
• Asia/Oceania TBD
• Africa/Europe TBD
• Americas TBD

If you have any concerns, please contact us at help@labkey.com.

Last updated: 2026-01-05

Sample Manager & LabKey LIMS Software Validation & Release Schedule - General

This is the generalized release schedule for LabKey Sample Manager & LIMS validation

Phase 1: Validation Planning and Initial Updates

Release: YY.MM.00
Goal: Align on validation scope and begin valpack updates.

• Week 0: Kickoff: LabKey + CompliancePath meet to discuss approach, timelines, and scope.
• Week 1: LabKey upgrades CompliancePath server (pre-work for validation updates).
• Weeks 1-4: CompliancePath begins updating Validation Pack (URS, Risk Assessment, OQ updates).

Phase 2: Customer PQ Preparation & Staging Environment Updates

Releases: YY.MM.02 – YY.MM.06
Goal: Prepare customers for PQ by upgrading test environments and communicating schedule.

• Weeks 2-6: LabKey sends communications to customers:
• Release notes for YY.MM.02–YY.MM.06
• Validation timeline & expectations
• Staging upgrade windows
• Rough plans for production upgrades
• Weeks 2-6: LabKey upgrades customer testing/staging environments.

Phase 3: Validation Pack Release & Production Upgrades

Release: YY.MM.08
Goal: Deliver final validation materials and complete production rollout.

• Week 8: LabKey upgrades CompliancePath and customer testing environments to YY.MM.08.
• Weeks 9-10: CompliancePath executes OQ testing and finalizes the Validation Pack updates.
• Week 10: CompliancePath releases the completed Validation Pack to LabKey and customers.
• Week 11: LabKey upgrades customer production environments to YY.MM.08.