Case Study
A pathology validation team organises 3,678 test scripts and 2,700 issues in Cymetryc and validates every discipline within a six-month window.
Large NHS foundation trust, hub-and-spoke pathology service, England

Executive Summary
A large NHS foundation trust implemented Epic as its new electronic patient record (EPR), with Epic Beaker as its laboratory information management system (LIMS). Pathology had just six months to validate and document every discipline before go-live, and pathology operations had not yet grasped how big Beaker clinical content validation (CCV) would be.
The trust had already used Cymetryc on a previous LIMS upgrade and chose it again for Epic Beaker. Its validation team combined CCV2 and CCV3 into a single “CCV2 Plus” phase of 3,678 test scripts, set them all up in Cymetryc and onboarded a large team of pathology testers and approvers.
Testers captured evidence with a click, approvers at three levels signed off as sections completed, and 2,700 issues were logged, assigned and retested in one place. The trust went live on time, with validation reports generated at the press of a button.
Six months to validate and document every pathology discipline before go-live
3,678 CCV2 Plus test scripts and 2,700 issues managed in Cymetryc
Live on time, with inspection-ready validation reports
“What made the difference for us is that everything is in one place from the testing point of view. Once you’ve got the hang of what is required to write a test case and put together a test plan, then it’s very straightforward to use.”
— Pathology Computer Systems Validation Lead, NHS foundation trust
The Challenge
Epic's phased approach puts the heaviest testing load in CCV2, which validates application workflows, and CCV3, which validates end-to-end clinical content between Epic Beaker, analysers, middleware and other systems including the EPR. Every test needed documented evidence for regulatory inspection, and accreditation bodies required validation reports showing what was tested, the outcomes and the evidence.
The trust's pathology computer systems validation team sits within pathology governance and quality. It had to bring a large operational team, many of them new to structured validation tools, through Beaker CCV on a fixed timeline.
“The big pressure was on us here [in] pathology because we had only 6 months to get all pathology disciplines validated and documented before our go live date. And it took a bit of momentum to get going because from the pathology operational side they didn’t really have a concept of how huge the Beaker Clinical Content Validation was going to be.”
— Pathology Computer Systems Validation Lead
The trust needed one platform a large, mixed team could adopt quickly, and that would stand up to UKAS and MHRA scrutiny.
The Project
Having used Cymetryc on a previous LIMS upgrade, the trust knew how difficult meaningful validation would be without it. After detailed discussions about security and a demonstration of how Cymetryc works, Epic agreed to its use for clinical content validation.
“Initially, Epic were not keen for [us] to use Cymetryc. They were very keen instead that we should follow their particular spreadsheet based formats for validation. After some detailed discussions about security and demonstrating how Cymetryc works, Epic were happy for us to use it for our clinical content validation.”
— Pathology Computer Systems Validation Lead
The trust combined CCV2 and CCV3 into a single phase it called CCV2 Plus, reflecting how its end users would actually test. All 3,678 scripts were set up and organised in Cymetryc. Much of the testing was done by pathology operations staff who were less familiar with Cymetryc than the pathology IT team, so three members of the validation team took turns as “Cymetryc Champion for the Week”, the go-to contact for anyone with a question.
“What is most amazing is that as a tester, they would just need to click on the little camera, collect their screenshot and it is automatically inserted into the Cymetryc testing platform, in the right place. It’s dated, timed, everything.”
— Pathology Computer Systems Validation Lead
Approvers at three levels, laboratory SME, service and clinical lead, saw each script's documented results and screenshots on a single screen. They could start approving as sections finished rather than waiting for the whole testing event, from any device and any location. Issues were logged from the testing screen with screenshot evidence, prioritised, assigned and returned to the queue for retesting once resolved.
Approvers could sign off sections as they were completed, without waiting for the whole testing event to finish.

Results & Impact
3,678
Test Scripts
CCV2 Plus scripts set up, executed and approved in Cymetryc
2,700
Issues Managed
Logged from the testing screen with evidence, prioritised, assigned and retested
6
Months to Go-Live
To validate and document every pathology discipline
3
Approval Levels
Laboratory SME, service and clinical lead approvers signing off as sections completed
“Putting together a manual validation summary report is a huge undertaking, even for a much smaller project than this one. Yet here all you do is you press a button, you tell it what you want it to produce and a short while later out comes this amazing report!”
— Pathology Computer Systems Validation Lead, NHS foundation trust
Next Phase
Pathology operations staff initially worried that Cymetryc would take more of their time. Seen across the whole project, it helped the overall validation significantly, and the doubters came to agree it would have been impossible to achieve what was achieved without it.
Before Epic Beaker, the trust had used Cymetryc for a biochemistry middleware upgrade, quality management system changes and transfusion management software validation. It now uses Cymetryc for every opportunity, including data migration projects where signed-off evidence feeds into its quality management system for a further layer of sign-off.
“Be prepared to be amazed and be prepared to learn and also to liaise with STS because we had amazing support the whole time.”
— Pathology Computer Systems Validation Lead, NHS foundation trust
Scripts can be copied, amended and reused, so each validation builds on the last.
The Cymetryc team can convert spreadsheets of data into test cases when needed.
A rotating Cymetryc Champion kept a large, mixed team moving.
