Pharmaceuticals & Life Sciences

QA & Test Automation for Pharmaceuticals & Life Sciences

QA & Test Automation 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

A flaky suite is worse than no suite. Once a team starts re-running failures to see if they pass, the tests have stopped providing information and started providing delay.

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how qa & test automation 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 QMS. 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. We hand over with runbooks, tests and a team that knows how it works, not a dependency.

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

QA & Test Automation 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

  • Test strategy defining what is automated and what deliberately is not
  • End-to-end coverage of the paths that carry revenue or risk
  • API and integration tests, which catch more per rupee than UI tests
  • Mobile testing on real devices, not only emulators
  • CI integration so tests gate every change
  • Flaky-test discipline, because a suite nobody trusts is worse than none

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.

What coverage should we aim for?

Full coverage of critical paths beats a high overall percentage. A suite covering checkout, auth and payments well is worth more than 90% coverage spread evenly across trivial code.

Manual or automated?

Both. Automate regression, repetition and anything running every release. Keep humans for exploratory testing and usability judgement, which machines are poor at.

Our tests keep failing randomly. Can you fix it?

Yes, and it is common work. Flakiness usually traces to timing assumptions and shared state, and fixing it is what makes a team trust the suite again.

QA & Test Automation 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