Pharmaceuticals & Life Sciences

ERP Integration & Automation for Pharmaceuticals & Life Sciences

ERP Integration & 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

Three-way matching is the highest-return automation in most procurement functions, and it is still done manually almost everywhere.

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how erp integration & 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 batch record review, 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. Six weeks to something running in production, not six quarters to a strategy document.

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

ERP Integration & 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

  • Integration without core modification, preserving upgradeability
  • Master data synchronisation and deduplication
  • Document and approval automation around the ERP
  • Three-way matching for procurement
  • Reconciliation reporting
  • Performance testing against production-scale volume

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.

Will this affect our SAP support agreement?

No. We integrate through supported interfaces and do not modify the core, which is exactly what preserves both support and upgradeability.

Do you work with Tally?

Yes, Tally Prime is extremely common among Indian mid-market businesses and integrates well for document and reconciliation automation.

What about our customisations?

We map them during discovery. Heavy customisation constrains some options, and we say which ones before committing to an approach.

ERP Integration & 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