PulseNex LabTrack
The Gap Register
Where every undocumented workaround gets named and ranked.
The Audit Trail Room
We build it so inspectors find nothing surprising.
The CAPA Desk
Observation received. Here is where the response takes shape.
The Validation Suite
IQ, OQ, PQ protocols written and executed with your team.
The Training Room
Your SOPs, your instruments, your people. No generic slides.
The Retainer Corner
A named consultant, monthly hours, no helpdesk queue.
2026-07-10
PulseNex LabTrack started in the spring of 2018 in a rented desk in a shared office in Edinburgh, with one client, a small bioanalytical CRO that had received a data integrity observation from the MHRA and needed help building a credible CAPA response. Dr. Miriam Osei-Bonsu-Bonsu had just left eight years of in-house quality systems work and was, frankly, not sure whether a solo consultancy would last six months. The CAPA project ran for four months, the client passed their follow-up inspection, and word spread to two of their contract partners. That was the beginning.
The name came later. 'PulseNex' was a working title that stuck because it described what the work actually is: tracking the pulse of a laboratory's data systems and finding the next point of failure before a regulator does. 'LabTrack' was added in 2019 when the scope expanded beyond data integrity into full LIMS implementation support. By 2021 the team had grown to four consultants, each with a background in analytical chemistry, quality assurance, or regulatory affairs, and the client base had spread across the UK, Ireland, and the Netherlands. We have never taken on more clients than we can serve properly, and we do not intend to start.
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"We had an MHRA inspection observation sitting on our desk for three months before we called PulseNex LabTrack. Within six weeks we had a CAPA response we were actually confident in. The follow-up inspection went without a further finding."Head of Quality AssuranceBioanalytical CRO, Cambridge
"The gap analysis was more thorough than anything our internal team had produced. They found a workaround in our sample login process that had been running undocumented for two years. We would never have caught it before an inspector did."Laboratory ManagerPharmaceutical manufacturer, Dublin
Dr. Miriam Osei-Bonsu-Bonsu spent eight years as a senior quality systems analyst at a contract research organisation in Cambridge before founding PulseNex LabTrack in 2018. She holds a PhD in analytical chemistry from the University of Edinburgh and previously led the data integrity remediation programme at a mid-size pharmaceutical manufacturer following a regulatory inspection that flagged systemic LIMS gaps. That project, which ran from 2015 to 2017, convinced her that most lab data problems are organisational before they are technical. Outside the office, she keeps a meticulous vegetable garden and insists that growing things slowly teaches you more about process control than any textbook.
Yes. We have worked with clients in Ireland, the Netherlands, and Germany, and we are comfortable with remote-first engagements. For gap analyses and mock inspections we prefer at least one on-site visit, but the rest of the work can be done remotely without any loss of quality.
For a laboratory with 20 to 50 staff and a single site, we usually plan for 12 to 16 weeks from kick-off to a fully documented, trained, and signed-off framework. Larger or multi-site organisations take longer. We will give you a realistic timeline in the discovery call, not an optimistic one.
That is actually where a significant portion of our work comes from. We help you build the CAPA response, the retrospective data review, and the corrective system in a sequence that regulators find credible. The key is starting the documented evidence trail immediately, which is why early contact matters.
We have direct experience with LabVantage, STARLIMS, LabWare, and several mid-market platforms including Labguru and SampleManager. We can also review a platform we have not worked with before, though we will tell you upfront if we think a specialist in that specific system would serve you better.