Pharmaceuticals & Life Sciences

IT for Pharmaceuticals & Life Sciences

IT 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

Licence and cloud contracts are where money hides. A contract review routinely finds spend nobody has examined in three years, and that alone often covers the engagement.

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how it 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. Every engagement opens with a measurement: the cycle time, the cost per transaction, or the error rate we are being asked to move.

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

IT 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

  • Current-state assessment across systems, contracts and capability
  • Build, buy or partner analysis with the reasoning documented
  • Vendor selection criteria and scored comparison
  • Roadmap sequenced by dependency and value
  • Cost review across licences, cloud and support contracts
  • Risk register with owners and mitigations

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.

Do you resell any of the products you recommend?

No. We take no commission from any vendor, and we disclose any relationship that could colour a recommendation. That independence is the product.

Will you also implement it?

We can, and you are not obliged to use us. The advice stands alone, and we would rather you tested it against other quotes.

How long does an assessment take?

Two to four weeks for most organisations. Long enough to be thorough, short enough that findings are still current when you act.

IT 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