Where this shows up

Life sciences IT teams often run change management as a compliance checkbox — a slow, manual process bolted onto validated systems to satisfy auditors, rather than a workflow built for CSV (Computer System Validation) requirements. The result is long approval queues, emergency changes used as a workaround, and audit trails reconstructed after the fact instead of captured as changes happen.

How we approach it

• Map change types against validation impact (GxP-critical vs. non-GxP) so low-risk changes aren’t stuck in the same queue as high-risk ones.
• Build compliance checkpoints directly into the change workflow — approvals, testing evidence, and sign-off captured in the tool, not in email threads.
• Redesign the Change Advisory Board’s remit and RACI so decisions are made by the right people, not everyone.
• Automate audit-trail capture so evidence is a byproduct of the process, not a separate reconstruction exercise.

What changes

• Faster approvals for low-risk, non-GxP changes
• Fewer emergency changes used to bypass the formal process
• An audit trail regulators can review without a scramble