Pharma software that stands up to inspection.
GxP/GMP-readiness engineering for clinical, manufacturing and supply — where validation, traceability and 21 CFR Part 11 audit trails are designed in, not bolted on before the inspector arrives.
Content reviewed
In pharma, if it isn't documented, it didn't happen.
Life-sciences software has to prove everything it does. Every system we ship is engineered to GAMP 5 practice, records every action in a tamper-evident audit trail, and enforces 21 CFR Part 11 electronic signatures so a record stays attributable, legible and lasting. We treat the validation package as a deliverable in its own right: URS, risk assessment, IQ/OQ/PQ, handed over with the code. The result is a system your validation team can take into an FDA or EMA inspection and a quality team can defend.
Regulated down to the record.
In pharma, a software defect becomes a deviation, a CAPA, and a question from a regulator about every batch the system ever touched. Under GxP/GMP, every record has to show who created it and where it came from, and the system has to be validated. Without that, the product cannot go near a patient.
We build life-sciences platforms where validation is the foundation: GAMP 5 computerised-system validation, 21 CFR Part 11 electronic signatures, tamper-evident audit trails and data integrity that holds to ALCOA+ across what we run in production. Quality workflows the QA team actually trusts, on infrastructure you control.
Layered on top is the traceability the sector demands — serialization and track-and-trace for DSCSA and EU FMD, cold-chain telemetry, and clinical data that flows cleanly between eTMF, EDC and the systems already in place, instead of becoming one more silo to reconcile.
Systems for pharma.
The life-sciences systems we deliver most. Different jobs, one shared requirement: every action provable afterwards.
Clinical trial & eTMF tooling
Trial master file, EDC-adjacent capture and site workflows with the audit trail an inspection demands.
Cold-chain & GxP monitoring
Temperature, excursion and IoT telemetry from warehouse to last mile, with alerts before product is lost.
Serialization & track-and-trace
Unit and aggregation serialization for DSCSA and EU FMD, with verification and exception handling built in.
Pharmacovigilance & safety
Adverse-event intake, case management and signal workflows wired for regulatory reporting timelines.
Validated quality systems
eQMS, deviation, CAPA and document control engineered to GAMP 5 practice and 21 CFR Part 11.
Regulatory submission support
Structured content and document tooling that feeds submissions instead of forcing a manual rebuild.
What the inspection will find.
When an inspector opens a system we built, these four things are already in place. Each is part of delivery, and your QA team holds the evidence.
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Shipped like a batch record.
The habits validated work demands, and what each one looks like inside a running system.
Validation by design
GAMP 5 risk assessment and IQ/OQ/PQ are part of delivery, so validation is finished when the system goes live.
Data integrity first
Records are attributable, complete and tamper-evident to ALCOA+, so a data-integrity question already has its answer on file.
Built for the inspector
21 CFR Part 11 signatures and audit trails are designed around the questions an FDA or EMA auditor actually asks.
Traceable to the unit
Serialization, batch and cold-chain data tie back to the individual unit, so a recall is precise instead of a guess.
From biotech to big pharma.
From a young biotech to a large manufacturer, every team on this list has to be ready for an inspector.
Few parts, each defensible.
The usual foundation for our GxP builds. Risk assessment decides what earns a place.
Validated as one system.
A single team builds the whole system, which gives you one system boundary and one validation package.
The validation questions.
Five answers your QA team can forward.
Do you deliver validated, GAMP 5 systems?
Yes. We treat computerised-system validation as part of the build. URS, risk assessment and IQ/OQ/PQ are produced alongside the code, and your QA team receives the full package at handover.
Do you support 21 CFR Part 11 e-signatures?
Electronic signatures, tamper-evident audit trails and access controls are part of the base system, so records stay attributable, legible and inspection-ready.
Can you handle serialization for DSCSA or EU FMD?
Yes — unit and aggregation serialization, verification and exception handling for DSCSA and EU FMD are part of the track-and-trace builds we deliver.
How do you protect data integrity?
Records are designed to ALCOA+: attributable, legible, contemporaneous, original and accurate. They are encrypted at rest and in transit, and every change is logged and queryable.
Can you integrate cold-chain and IoT monitoring?
We ingest temperature and excursion telemetry from devices across the chain, flag breaches in real time, and tie every reading back to the batch and unit affected.
Anything we missed?
Put it in a briefBuilding a system that
has to pass audit?
Outline the process, your regulator and what needs validating. A senior engineer gives you an honest view on feasibility within one business day.