Pharmaceuticals & Life Sciences

RAG & Knowledge Retrieval for Pharmaceuticals & Life Sciences

RAG & Knowledge Retrieval 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

What changes when it is pharmaceuticals & life sciences

Permission-aware retrieval is not optional in an enterprise. If a user cannot open a document in SharePoint, the assistant must not quote it. We enforce that at the retrieval layer, not in the prompt.

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how rag & knowledge retrieval 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 batch record review, usually integrated against pharmacovigilance databases. 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.

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

RAG & Knowledge Retrieval 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

  • Ingestion pipeline for your real document formats
  • Chunking and embedding strategy tuned to your corpus
  • Hybrid keyword plus vector retrieval with reranking
  • Citations on every answer, traceable to the source page
  • Permission-aware retrieval that respects existing access rules
  • Retrieval quality benchmarked against a labelled question set

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.

RAG or fine-tuning?

RAG for knowledge that changes and must be cited; fine-tuning for style, format and task behaviour. Most production systems use RAG for the facts and light fine-tuning or few-shot prompting for the form.

How accurate will it be?

We build a labelled question set from your domain and report retrieval precision and answer accuracy against it. That number is the deliverable. We do not ship a system whose quality nobody has measured.

Can it respect our existing permissions?

Yes. Retrieval is filtered by the user's actual entitlements, so the assistant can never surface a document the user could not already open.

RAG & Knowledge Retrieval for pharmaceuticals & life sciences, worth a conversation?

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

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