What Infosys / HCL / Wipro gets wrong in Healthcare
FDA 21 CFR Part 11 imposes audit trail requirements on electronic records that are specifically designed to ensure that records are attributable — meaning every change is traceable to a specific individual. A pharmaceutical system developed by a rotating offshore team, where engineers change as the managed services contract evolves, creates audit trail attribution complexity that validation teams spend months resolving. The regulation assumes individual accountability; the offshore staff augmentation model is designed to make individuals interchangeable.
GxP validation in a pharmaceutical environment requires a change control process that can trace every system modification to a specific requirement, a specific engineer, and a specific test result. Infosys, HCL, and Wipro's staff augmentation model — where the contract deliverable is engineering hours, not a validated system — produces change management records that satisfy time-and-materials billing requirements but not GxP validation requirements.
Manufacturing execution systems, laboratory information management systems, and clinical data management platforms all require validation that survives FDA inspection. An MES built by a 40-person offshore team with quarterly team turnover will produce a validation package that describes what the system does on paper — not what the current team understands the system to do in production.
What we deploy instead
Our pharmaceutical technology teams deliver GxP-validated systems — not systems with validation documentation attached. Validation is built into the engineering process from the first sprint. The validation package reflects what was actually built and tested, not what was planned.
Onshore delivery with the attribution and accountability that 21 CFR Part 11 requires. Every architectural decision is made by an engineer who is accountable for that decision throughout the engagement.
FDA 21 CFR PART 11 and HIPAA built into the architecture from day one — enforced automatically by ALICE at every commit.
Fixed-price engagements. Production system in 8-20 weeks. No discovery phase. No change orders.
Domain-qualified engineers with healthcare experience. The senior engineer who scopes the engagement is the senior engineer who delivers it.
Full source code and documentation transferred at close. No licensing. No managed services dependency.
The compliance difference
FDA 21 CFR Part 11, GAMP 5, GxP validation. Offshore delivery creates specific Part 11 audit complexity that onshore delivery eliminates at the source.
What switching from Infosys / HCL / Wipro looks like
Pharmaceutical technology engagement: 14-22 weeks for a GxP-validated production system. Team: 8-14 engineers, 1 validation specialist. Fixed price. Full validation documentation package at close.
Architecture review and scope definition. We review existing deliverables and identify gaps.
Scope locked, team assembled, first sprint underway. Working code from week two.
First production milestone — a working integration or system component, not a document.
Full IP transfer. Source code, documentation, operational runbooks. Your team runs the system.
Failed Vendor Recovery Playbook
Step-by-step framework for recovering from a failed Infosys / HCL / Wipro engagement — from emergency stabilisation through full re-platforming. 4-phase playbook covering stabilise, assess, transition, and normalise.