The engineering work and the regulatory work are delivered by the same senior people.
Current technology, including what has most recently entered GxP environments.
Each of these supported by a documented, risk-based regulatory position appropriate to its intended use.
Clients typically come to us with a system that works and a compliance position that does not, or with an inspection date already set.
Lifecycle activities from intended use and requirements through release, operation and retirement, scaled to the assessed risk. CSA principles are applied where appropriate, with documented testing where warranted by risk and applicable requirements.
ALCOA+ reviews across manufacturing and laboratory systems, from gap analysis through to CAPA close-out.
We architect and build Azure, AWS and Dynamics 365 Business Central environments for GxP use, then support their qualification, including the shared-responsibility boundary, within the client's quality system.
MES, DCS, SCADA, historian and PLC layers validated as one system rather than five, with ISA-95 flows to ERP and ISA-88 batch structure defined explicitly.
IEC 62443 across the full lifecycle — asset inventory, zones and conduits, mitigation design and implementation support — on an estate that must stay qualified throughout.
For findings already issued or an inspection approaching, we support the client in establishing the technical and regulatory position, defining the remediation strategy and implementing agreed actions within the client's quality system.
Supplier and vendor audits carried out by auditors who read the architecture as well as the quality manual. Also internal audits and second-opinion reviews before a package goes to approval.
Migration from document-based validation to Kneat, Panaya, MasterControl or TrackWise, including the process redesign that makes the licence worthwhile.
Mapping how the process runs today, then applying automation or AI where it changes the economics. We also qualify the resulting components where they fall within GxP scope.
A risk-based approach holds only where the rationale can be defended technically under challenge. Without that grounding, broad testing becomes the default.
We can argue why a particular function is low risk by reference to how it is built — configuration versus custom code, vendor-tested versus site-specific — rather than by asserting it. The result is a smaller test set with a justification that holds under questioning.
Supplier testing can often be leveraged rather than repeated, provided its quality can be assessed. We audit the vendor's evidence technically, take credit where it is warranted, and test only the gap. That judgement often removes more effort than any other single decision in a validation project.
Much rework originates in specifications that do not match the system, written without sight of the configured environment. When the same people read the architecture and write the requirements, review cycles shorten and the traceability matrix stops being an exercise in retrofitting.
We arrive able to read the P&ID, the network diagram and the recipe model, which shortens the first phase of an engagement from weeks to days.
Material savings can come from a justified determination that data or functionality is outside GxP scope, or from appropriate software categorisation. These decisions require both regulatory and technical grounding and must be documented within the client's quality system.
A regulatory problem found during design costs a conversation. The same problem found during qualification costs a deviation, a change and a delay. Involving both competences while the system is designed is the least expensive point at which to address compliance.
The regulation is common; the pressure points are not. What breaks in a CDMO is rarely what breaks in a scaling biotech.
Filling lines, inspection systems, MES and DCS layers validated as one architecture, with data flowing to ERP under ISA-95 rather than through spreadsheets.
Fast-moving processes where the system changes faster than the documentation. Change control designed to keep up rather than to hold everything still.
Multiple clients, multiple quality systems, one plant. Segregation, per-client traceability and audit readiness for inspections you do not schedule.
Software as part of the device and software that produces it — two different regulatory questions, frequently answered as if they were one.
HPLC, chromatography, balances, dissolution and environmental monitoring are frequent areas of data integrity focus, particularly where audit trail review is not designed around actual risk.
Approaching a first inspection. We help establish a proportionate quality and validation framework around the technology already in use, while identifying where redesign or remediation is necessary.
Set out in advance, because commercial terms left unclear are a frequent cause of delay in procurement.
Senior consultant embedded in your team at a daily rate, on site or remote. You direct the work and keep full flexibility on scope.
Suits work where the scope will move, or where you need capacity more than a defined deliverable.
Fixed scope, fixed deliverables, fixed price. We carry the estimation risk. You know the cost before the first day is worked.
Suits a definable deliverable — a validation package, an assessment, a remediation.
A monthly retainer with an agreed block of advisory time and a priority response commitment, so the terms do not have to be negotiated when an inspection or a deviation arises.
Suits operations where the risk is timing rather than volume.
That is a normal place to start. Describe the system and the deadline; we will tell you which discipline applies and roughly what it costs.