Pharma software that passes inspection.
GxP/GMP-compliant systems 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.
In pharma, if it isn't documented, it didn't happen.
Life-sciences software lives or dies on whether it can prove what it did. Every system we ship is validated to GAMP 5, 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 — URS, risk assessment, IQ/OQ/PQ — as a deliverable, not paperwork chased after launch. The result is a system an FDA or EMA inspector accepts and a quality team can defend.
The sector, honestly.
In pharma, a software defect is not a ticket — it is a deviation, a CAPA, and a question from a regulator about every batch the system ever touched. GxP/GMP obligations mean a record has to be attributable, traceable and validated from the first line of code, or 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 platforms we ship most often for this sector — each scoped to a number the business actually cares about.
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 validated to GAMP 5 and 21 CFR Part 11 from line one.
Regulatory submission support
Structured content and document tooling that feeds submissions instead of forcing a manual rebuild.
Numbers, not slideware.
Every engagement is scoped to a measurable result. The kinds of outcomes we build pharma systems to move — and hold ourselves to.
The hard parts, handled.
The principles we build by in this sector — and what each one means once the system is live.
Validation by design
GAMP 5 risk assessment and IQ/OQ/PQ are part of delivery, so the system is validated on day one, not remediated after.
Data integrity first
Records are attributable, complete and tamper-evident to ALCOA+, so a data-integrity finding is a query, not a crisis.
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 startups to scale.
The kinds of teams across life sciences we partner with — each with different stakes, the same standard of craft.
Chosen for the problem.
Framework-agnostic, outcome-opinionated. A representative stack for pharma — the mix bends to your problem, never the reverse.
One team. Zero hand-offs.
The CODT disciplines we most often combine to build for pharma — same architecture, same engineers, no integration tax.
Questions, answered.
The things buyers in pharma ask us most. Anything else — put it in a brief, a senior engineer replies within a business day.
Do you deliver validated, GAMP 5 systems?
Yes. Computerised-system validation is part of delivery — URS, risk assessment and IQ/OQ/PQ — so the system is validated on launch rather than remediated after, with the package handed to your QA team.
Do you support 21 CFR Part 11 e-signatures?
Electronic signatures, tamper-evident audit trails and access controls are built in from line one, so records are 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 — encrypted at rest and in transit, with every change 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.
Building a system that
has to pass audit?
Tell us about your process, your regulator and your validation needs. A senior engineer replies within one business day with an honest feasibility read.