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Pharmaceuticals

GxP-grade software for clinical, regulatory, and commercial functions — engineered for audits, validated for production.

  2. Industries
  3. Pharmaceuticals

The landscape

Software that holds up in a regulated lifecycle.

Pharma technology lives under unforgiving constraints — FDA 21 CFR Part 11 for electronic records, GxP (GMP, GCP, GLP, GVP) for the activity it supports, EU Annex 11 for computerized systems, and increasingly EU AI Act and HIPAA-class requirements when models and patient data enter the loop. The systems that get certified, audited, and inspected can't be retrofitted to meet those standards. They have to be built for them.

We build clinical-operations, regulatory-affairs, manufacturing-execution, pharmacovigilance, and commercial-analytics software that's validated under GAMP 5 Category 4/5 and engineered to the CSA (Computer Software Assurance) model FDA now expects. Every artifact — requirements, design, traceability matrix, IQ/OQ/PQ — is produced as part of the build, not bolted on at the end.

Where AI and real-world data enter the picture (signal detection in PV, protocol optimization, RWE generation), we apply the responsible-AI controls and explainability the EMA and FDA increasingly expect to see.

Pharmaceuticals

21 CFR 11

Electronic records & signatures

GAMP 5

Validation lifecycle aligned

CSA

FDA Computer Software Assurance ready

EU Annex 11

Computerised systems

Challenges we hear

What slows pharma technology programs

Validation overhead

Traditional CSV (Computer System Validation) treats every change as a documentation event. Without CSA-style risk-based testing, even small releases take weeks.

Data integrity (ALCOA+)

Inspectors hit data integrity findings every year. Audit trails, time-stamping, and access controls have to be engineered — not just documented.

Veeva / SAP sprawl

Commercial, clinical, regulatory, and quality systems often run on different vendor stacks with shaky integrations. End-to-end traceability becomes a manual exercise.

Trial complexity

Decentralized trials, ePRO, eConsent, real-world data — all changing faster than legacy EDC and CTMS stacks can absorb.

Pharmacovigilance load

Case volume keeps rising; ICSR processing is increasingly the bottleneck. NLP / LLM-assisted triage helps, but only with validation discipline behind it.

AI under regulation

FDA and EMA expect explainability, lifecycle controls, and human oversight for ML-based clinical or quality decisions. AI projects die at the IRB / QA review when this isn't built in.

How gmware helps

What we build for pharma and biotech

Clinical Operations

CTMS / EDC / eTMF extensions, ePRO & eConsent apps, decentralized-trial tooling. Veeva Vault, Medidata, Oracle Health Sciences integrations.

Regulatory Affairs

RIM, submission management, IDMP-aligned data models, eCTD authoring / publishing helpers, structured-content templates.

Manufacturing & Quality

MES, EBR, deviation / CAPA workflow, batch-release dashboards. Integrated with SAP, LIMS, and the shop-floor systems that already exist.

Pharmacovigilance

ICSR intake, triage, MedDRA coding, E2B(R3) export. LLM-assisted summarization with a validated review path.

Commercial Analytics

Field-force effectiveness, multichannel marketing analytics, payer data, RWE platforms. Tableau / Power BI / Looker on top of a governed warehouse.

Validation Engineering

GAMP 5 + CSA-aligned validation packages: URS, FS, DS, traceability matrices, IQ / OQ / PQ. Automated testing as objective evidence — not Word screenshots.

Standards & Compliance

Regulations and standards we engineer to

21 CFR Part 11

Electronic records & sig

EU Annex 11

Computerised systems

GAMP 5 (2nd ed.)

Validation lifecycle

FDA CSA

Risk-based assurance

ICH E6 (R3) GCP

Trial conduct

ALCOA+

Data integrity principles

IDMP

Product identification

HIPAA / GDPR

Subject data

Outcomes

KPIs we help teams move

Cycle time

Submission, release, ICSR

Audit findings

Critical / major / minor

Deviation rate

Per batch / per site

QA / QC effort

FTE on validation activity

FAQ

Common questions

FDA's Computer Software Assurance draft guidance shifts validation from "test everything, document everything" to risk-based, unscripted, and automation-friendly testing — with the rationale and evidence proportional to patient impact. Done well, it cuts validation effort 30–50% while improving audit outcomes. We design CI/CD with CSA in mind from the first release.

Yes — Veeva Vault APIs, SAP S/4HANA via OData / RFC / iDoc, LabVantage / LabWare / STARLIMS connectors. We've shipped integrations into all of them under GxP validation.

Documented model lifecycle (data, training, evaluation, deployment, monitoring), human-in-the-loop on regulated decisions, model cards, versioned datasets, drift monitoring, and explainability appropriate to the use case. FDA's "Good Machine Learning Practice" draft principles and the EU AI Act's high-risk obligations are our default starting point.

Both. We've built tooling that sponsors use internally and platforms CROs run for their sponsor clients. The validation discipline is the same; the governance and access controls differ.

Services we deliver here

Products that fit

Browse other industries we serve

Need a regulated build that won't slow down at QA?

A focused conversation with our pharma lead. We'll talk validation, integration, and the shortest path through your QMS to live software.