Why I'm Partnering with Libertas Software Research on ORDU Studio

Why This Partnership Matters

I've spent the best part of twenty-five years on one side of a very particular table: the side that walks into an organisation, asks to see the evidence, and decides whether it holds up. Across GCP, GCLP, GVP, and GMP audits, and inspections from the FDA, MHRA, BfArM, and CFDA, the question I've asked, in one form or another, has always been the same: can you show me, in the record, exactly what happened and why?

Most systems can't. Not fully. They can tell you an action was logged, but not always why it was taken, who it was escalated to, or how the decision fits into the wider sequence of events. That gap is where compliance programmes get exposed, not because people did the wrong thing, but because they can't prove they did the right thing.

That's why I'm pleased to announce a new partnership: I'll be acting as Subject Matter Expert for Libertas Software Research (LSR), supporting their work generally and, in particular, the ongoing development of ORDU Studio, LSR's modular multi-agency incident management platform.

Why ORDU Studio Specifically

Incident response is one of the hardest environments to build a genuinely auditable system for. Everything happens fast, under pressure, across multiple agencies who may not share systems, terminology, or reporting standards. The instinct in that environment is to prioritise speed and coordination, and rightly so. But the record left behind matters just as much, especially where organisations carry statutory obligations, such as those introduced under the Terrorism (Protection of Premises) Act 2025 (Martyn's Law).

What drew me to ORDU Studio is that it's being built with that second half of the problem in mind from the outset, not as a compliance bolt-on added once the platform is otherwise finished. My role is to bring the same scrutiny to it that I'd bring to a live regulatory inspection: not "does the system log activity," but "does the resulting record survive being examined critically by someone outside the organisation."

How This Works

This isn't a full-time embedded arrangement, it's a standing SME relationship. LSR can call on me for audit and compliance input on ORDU Studio's development as it evolves, and I'll be available to LSR's wider client base where independent, inspection-grade assurance is needed alongside their software delivery work. That structure suits the reality of audit work: it's most valuable applied at the right moments, by someone who understands both the regulatory landscape and the system being scrutinised, rather than as a one-off exercise squeezed in before an inspection.

What This Means for Organisations Considering ORDU Studio

If you're evaluating an incident management platform and your organisation has regulatory reporting obligations, multi-agency coordination requirements, or exposure under frameworks like Martyn's Law, the question worth asking any vendor is simple: if a regulator or inquiry asked to see your record of this incident, would it hold up?

I'm looking forward to helping make sure the answer for ORDU Studio is yes, and to working with the LSR team on what comes next.

Shane Comiskey is Managing Director of 360 Clinical Research Consultancy (360 CRC), a specialist compliance and auditing consultancy. He holds an MSc in Biotechnology and an MSc in Computer Science, both from Ulster University, and has spent over two decades in GxP quality assurance and audit leadership, including senior roles at Chiltern, ICON plc, PharmaNet/i3, and MDS Pharma Services.