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Pharmaceuticals & Life Sciences

AI Governance & Compliance for Pharmaceuticals & Life Sciences

AI Governance & Compliance for pharmaceuticals & life sciences, built around the constraint that defines the sector: GxP validation means every system change needs documented evidence before it reaches production.

Regulations in scope
5
Systems we integrate
5
Typical first release
6 weeks
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What changes when it is pharmaceuticals & life sciences

Governance written after deployment is documentation. Governance designed alongside the system is a control, and only one of those survives an audit.

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how ai governance & compliance has to be built here, the guardrails, the approval points and the evidence trail are design inputs rather than things bolted on before go-live.

The workload we are most often asked to take on first is regulatory dossier assembly, usually integrated against SAP. We start from the constraint, not the capability, what the system must never do, who signs off, and what happens when it is wrong.

Deployed across regulated and unregulated sectors, with audit trails where the regulator expects them. You own the code, the models where they are open-weight, and the documentation to run it without us.

The sector constraints we design around

Defining constraint
GxP validation means every system change needs documented evidence before it reaches production
Regulations in scope
CDSCO · US FDA 21 CFR Part 11 · EU GMP Annex 11 · GxP validation · ICH guidelines
Systems of record
LIMS · QMS · eTMF · SAP · pharmacovigilance databases
Where we usually start
batch record review

AI Governance & Compliance workloads in pharmaceuticals & life sciences

  • batch record review
  • adverse event intake and coding
  • regulatory dossier assembly
  • deviation and CAPA drafting
  • literature monitoring

What is included

  • System inventory and risk classification
  • Model cards and data provenance documentation
  • Bias and fairness testing where it applies
  • Human oversight and escalation design
  • Evidence pack assembled for auditors
  • Ongoing monitoring and incident procedures

Questions from this sector

Can an AI system be GxP validated?

Yes, with a documented validation approach, IQ/OQ/PQ, defined intended use, change control and evidence of consistent performance. We build the validation pack alongside the system, not afterwards.

How do you handle 21 CFR Part 11?

Audit trails, electronic signatures, access control and record integrity designed in from the start, because retrofitting them is effectively a rebuild.

Does the DPDP Act apply to our AI systems?

If you process personal data of individuals in India, yes, including training data and prompts. Consent, purpose limitation and data-principal rights all apply, and prompt logs are frequently the overlooked exposure.

Do we need ISO 42001?

Not always, but it is becoming a procurement expectation in enterprise and public-sector deals. It is worth pursuing when your buyers ask for it.

Can you work with our existing GRC function?

Yes. We map AI-specific controls onto the framework you already run rather than introducing a parallel one.

AI Governance & Compliance in other sectors

Financial ServicesBankingInsuranceHealthcare & HospitalsLegal ServicesGovernment & Public SectorTelecommunicationsDefence & AerospaceEducation & EdTechEnergy & Utilities

Other capabilities for pharmaceuticals & life sciences

AI Governance & Compliance for pharmaceuticals & life sciences, worth a conversation?

Tell us the workload and the regulation it sits under. We will tell you what is realistic.

Talk to an engineerWhatsApp us

Or email bd@dtrasglobal.com · call +91 74118 77878