−40%
audit prep cycle time across 14 sites
IT × GxP × Global Delivery
Build systems that innovate fast and stay compliant.
Enterprise IT services and GxP-compliant technology solutions for life sciences, pharma, healthcare and biotechnology. ITGxP unifies enterprise IT, regulated validation, and structured offshore delivery — so your digital ecosystem is scalable, secure, and inspection-ready from day one.
Trusted acrossLife SciencesPharmaceuticalsBiotechnologyHealthcareMedical Devices
Aligned with the frameworks our clients are audited against
- FDAFDA 21 CFR Part 11
- EUEU Annex 11
- G5GAMP 5
- ISOISO 27001
- HIHIPAA
- SOCSOC 2
- ICHICH Q9
Life Sciences
Pharmaceuticals
Biotechnology
Healthcare
Medical Devices
Enterprise Technology
Data-driven Organizations
Life Sciences
Pharmaceuticals
Biotechnology
Healthcare
Medical Devices
Enterprise Technology
Data-driven Organizations
0%
Service uptime target
0/7
Global support coverage
0
Service pillars unified
0%
Audit-ready documentation
Outcomes
Selected results from real engagements.
A snapshot of outcomes we've delivered across regulated and enterprise environments. Detailed case write-ups are available under NDA.
3×
faster reporting on a unified data platform
−55%
mean-time-to-resolve under 24/7 pod
0
findings on a follow-up regulatory inspection
100%
audit-ready validation documentation delivered
How it works
The shape of an inspection-ready system.
Every regulated system we deliver flows through the same operating model — from code to audit evidence. Hover a node to see what we own at each step.
CSV evidence
Validation
URS, FRS, IQ, OQ, PQ documentation is generated and reviewed alongside the release — not retroactively. Traceability is maintained automatically.
URS / FRSIQ / OQ / PQTraceability matrix
What we do
Three pillars. One outcome: systems you can trust.
ITGxP blends enterprise IT services, regulated-industry compliance, and global delivery into a single operating model. Hover to explore each pillar.
gxp
GxP Compliance & Validation
- Computer System Validation (CSV)
- URS / FRS / IQ / OQ / PQ documentation
- Data integrity assessments
- Quality & regulatory consulting
- Audit & inspection readiness
Built for the stage you're at
Startup, growth, or enterprise.
The engagement model bends to where you are — not the other way around.
Operationalize what's working — at the next order of magnitude.
For organizations crossing the threshold where ad-hoc IT and tribal validation stop working: build the operating model that holds at 10×.
- Managed services with SLAs
- Validation lifecycle programs
- Data platforms with governance
- Multi-site rollouts
Validation lifecycle
Inspection-ready, by design.
We map every regulated system through a documented validation lifecycle — so audits stop being a fire drill and start being a formality.
URS — Capture business and regulatory expectations.
How we engage
Three shapes most engagements take.
Most clients use a mix. Pick the entry point that fits the scope you're scoping.
Managed services
Ongoing operations under defined SLAs. We run the systems, you focus on the business.
- 24/7 monitoring & incident management
- L1–L3 application support
- Patch, release, and change management
- Quarterly business reviews
Project-based
Defined scope, milestones, and outcomes — for migrations, validations, remediations, or builds.
- Fixed-scope or T&M models
- Validation package delivery
- Cloud migration & modernization
- Compliance remediation programs
Offshore pod
A dedicated team under your direction with our governance, security, and quality wrapped around it.
- Structured offshore delivery
- Role-based access & controls
- Secure remote-access framework
- Cost-optimized for scale
Why ITGxP
The partner you bring in when both sides matter.
The teams we work with face two pressures at once: ship faster, and prove everything is compliant. We're built for that intersection.
Two disciplines, one team.
Most partners do IT or compliance. We do both — under one governance model, with traceability between engineering and validation.
AI-assisted operations.
Predictive monitoring, automated triage, and AI-aided validation reduce toil so your team focuses on outcomes, not tickets.
Audit-defensible, always.
Every system we touch comes with URS, FRS, IQ, OQ, PQ, and traceability — packaged for inspection on day one.
Global, but governed.
Offshore pods you can scale with role-based access, secure remote-access controls, and structured documentation.
Insights
Field notes from the IT/GxP intersection.
Practical writing on the moments where engineering decisions and regulatory expectations actually meet.
Building inspection-ready cloud migrations in regulated environments.
A practical playbook for migrating GxP-relevant workloads to cloud without forfeiting validated state — covering CSV strategy, qualification, and data integrity controls.
12 min readRead
Why CSV documentation drift quietly kills audits.
Validation packages decay between releases. Here's how we keep URS, FRS, IQ/OQ/PQ in lockstep with the system — and what to do when they aren't.
8 min readRead
Designing offshore pods that pass enterprise governance.
Role-based access, structured handoffs, and audit-grade documentation. What separates an offshore pod that scales from one that becomes a liability.
10 min readRead
Ready when you are
Tell us what you're building.
Whether it's a managed services engagement, a CSV remediation, or a full offshore pod — we'll respond within one business day.