Industry

AI for Pharmaceuticals & Life Sciences

Regulated document workflows, pharmacovigilance and manufacturing quality, where validation is the deliverable.

Capabilities
39
Regulations in scope
5
Systems integrated
5

The constraint that defines this sector

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. Everything we build here is shaped by that before it is shaped by the technology, the guardrails, the approval points and the evidence trail are design inputs, not things added before go-live.

We start from the constraint, not the capability, what the system must never do, who signs off, and what happens when it is wrong.

Built by engineers who ship production systems, not by a practice that subcontracts the build. You own the code, the models where they are open-weight, and the documentation to run it without us.

Sector context

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

Workloads worth automating here

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

Capabilities for pharmaceuticals & life sciences

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.

AI in pharmaceuticals & life sciences, where would you start?

Bring us the constraint, not the technology. We will tell you what is realistic under it.

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