Pharmaceuticals & Life Sciences

Managed Support & AMC for Pharmaceuticals & Life Sciences

Managed Support & AMC 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

Monitoring only works if alerts reach a human who can act. A dashboard nobody watches is a record of what went wrong, not a system that prevents it.

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how managed support & amc 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 adverse event intake and coding, usually integrated against LIMS. 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. 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

Managed Support & AMC 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

  • Written response and resolution targets by severity
  • Monitoring with alerts that reach a person, not a dashboard nobody watches
  • Security patching and dependency upgrades on a schedule
  • Bug fixes within scope, with enhancements quoted separately
  • A monthly enhancement allowance so small changes are not projects
  • Documented runbooks, updated as the system changes

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 is covered versus extra?

Fixes to agreed functionality, monitoring, patching and the monthly enhancement allowance are covered. New features and scope changes are quoted separately, and the boundary is written down rather than argued later.

Will you support a system you did not build?

Yes, after a code and infrastructure audit. Occasionally the audit changes the recommendation, and we would rather say that up front.

Do you offer 24x7?

Where the system genuinely warrants it. For most business applications, extended business hours with a defined escalation path costs far less and serves just as well.

Managed Support & AMC 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