Custom software
Systems built for how your business actually runs, replacing the spreadsheets and workarounds holding it together.
How it worksAll industries
Regulated production
The batch record is part of the product.
Formulation development, batch manufacturing records, stability studies, and release control in one system instead of four and a shelf of files.
Where the standard system leaves the cost in place.
A pharmaceutical operation produces two things at once: the batch, and the evidence of how the batch was made. Most plants run the first on an ERP and the second on paper, which means the two are reconciled by hand, after the fact, by the people least able to spare the time. The gap is where deviations get discovered late, where a stability pull point gets missed, and where an inspection stops being a formality. We build the system that produces both at the same time. None of these are unusual. All of them are expensive in a way that only shows up during an audit or a recall.
- The batch manufacturing record is printed, filled in by hand during the batch, and reviewed weeks later when the material has already moved.
- R&D keeps formulation trials in notebooks and spreadsheets, so scaling a product from bench to commercial batch size restarts the documentation from nothing.
- Stability pull points sit on a wall chart or a calendar reminder, and a missed pull is discovered when the report is being compiled.
- Deviations and CAPAs live in an email thread and a Word register, so closure dates and effectiveness checks are argued about in front of the auditor.
- Which vendor is approved for which grade of which material depends on one person remembering, and incoming release waits on them.
Built for pharmaceuticals.
Built on the same core our products run on, extended with the records and rules this sector is actually judged against. These are scopes we build and integrate, not shelf modules with a licence key.
R&D and formulation records
Trials, formulation versions, and yields held as structured records rather than notebook entries, with the path from bench to pilot to commercial batch carried forward instead of rebuilt. This is usually the highest-value module in the sector, because it is the one part of the operation that no ERP covers.
Electronic batch records
BMR and BPR executed on screen with step-level sign-off, in-process checks captured at the step, yield reconciliation calculated rather than typed, and deviations raised at the moment they occur.
Stability programme control
Protocols, chambers, and pull schedules driven by the system, with results recorded against specification and shelf-life justification assembled from the study rather than from memory.
Deviations, CAPA and change control
Quality events with a named owner, a due date, a linked investigation, and an effectiveness review that the system will not let you skip closing.
Batch genealogy and mock recall
Full trace from API and excipient lot through intermediate to dispatched batch, in both directions, so a mock recall is a query rather than a fortnight of file retrieval.
Release, retest and dispatch gating
QC results that gate dispatch, quarantine and hold locations enforced in stock, retest dates tracked, and certificates of analysis generated from the results already in the system.
What it has to be able to prove.
Compliance fails when it is a parallel activity. These obligations are carried by the system that runs the operation, so the evidence exists because of how work was recorded rather than because someone assembled it afterwards.
Data integrity by construction
Attributable, legible, contemporaneous records with a complete audit trail, electronic signatures, and no route to a silent edit. Integrity comes from how the system records, not from a policy document asking people to be careful.
Inspection-ready traceability
Genealogy, material certificates, equipment logs, and personnel sign-offs linked to the batch they belong to, retrievable in the order an inspector asks for them rather than the order they were filed.
Validation documentation support
Requirement traceability, IQ, OQ, and PQ artefacts produced as part of the build. Validation stays a joint exercise with your quality function, but the evidence it needs is generated rather than reverse-engineered.
What it runs on.
The sector layer is built. The operational core underneath it is not a proposal: it is running in production with clients today.
ERPMachERPLiveThe operational spine: procurement, production, inventory, finance, and statutory reporting, extended with the batch and quality structures the sector requires.See what it does
SIMSMach SIMSLive with clientsLot-level stock control, expiry and FEFO discipline, quarantine locations, and the movement history that batch genealogy is built from.See what it does
What it returns.
The record exists when the batch does
Documentation is produced during manufacture rather than reconstructed after it, so review is a check rather than an investigation.
Quality events close on time
Owners, dates, and effectiveness checks are tracked by the system, so nothing sits open until an audit finds it.
Recall becomes a query
Any lot can be traced forward to every customer it reached and backward to every input it came from, in minutes.
Where this normally starts.
Which of these applies depends on how well the constraint is already understood. A review that finds the real one usually turns into a build.
Data and reporting
Turning scattered records into dependable, current reporting that leaders can act on rather than argue about.
How it worksQuestions we actually get asked.
Do we have to replace our existing ERP?
Usually not immediately. The gap in most pharmaceutical operations is not finance or purchasing, it is the quality and batch record layer, and that can be built alongside what you already run and integrated with it. If the existing system is the actual constraint we will say so, but replacing a working ledger is rarely where the return is.
How do you handle computer system validation?
As part of the build rather than as an afterthought. We produce requirement traceability, design documentation, and IQ, OQ, and PQ artefacts, and we build the audit trail and access control that validation is going to test. The validation itself is executed with your quality function, because they own the outcome.
Can R&D and production genuinely run on the same system?
That is the point of doing it. When formulation development, scale-up, and commercial manufacturing share one structure, technology transfer stops being a document handover and becomes a change of status on records that already exist. R&D keeps the flexibility it needs, but the output is structured from the start.