Pharmaceuticals & Life Sciences

Cybersecurity & VAPT for Pharmaceuticals & Life Sciences

Cybersecurity & VAPT 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

We write the report for the people who will read it, your engineers need reproduction steps, your auditors need scope and methodology, and those are different sections.

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how cybersecurity & vapt 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. 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. 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

Cybersecurity & VAPT 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

  • Scoped testing across web, API, mobile or network as agreed
  • Findings ranked by exploitability and business impact, not by scanner severity
  • Proof-of-concept for each finding so nobody debates whether it is real
  • Remediation guidance specific to your stack, not generic advice
  • Free re-test after fixes, because an unverified fix is a hope
  • Report formatted for the auditors and clients who will ask for it

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.

How often should we test?

Annually as a baseline, plus after any significant change to authentication, payments or data handling. Continuous scanning between manual tests catches the obvious regressions.

Will testing break our systems?

We agree scope and intensity first, and destructive tests are excluded unless you explicitly want them in a staging environment. Production testing is deliberately careful.

Do you help fix the findings?

Yes, as a separate engagement if you want it, and the re-test is included either way so you can verify your own team's fixes.

Cybersecurity & VAPT 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