What Deloitte gets wrong in Healthcare
Deloitte's life sciences practice generates more revenue than most pharmaceutical companies spend on a Phase II clinical trial. The revenue comes from transformation programs, ERP implementations, and regulatory strategy engagements. The delivery track record — Zimmer Biomet suing Deloitte for $170M because their ERP implementation made it impossible to ship products — suggests that the revenue is not correlated with successful delivery.
FDA 21 CFR Part 11 compliance in pharmaceutical technology is not forgiving of the Deloitte model. A validated system requires that every electronic record and signature be attributable, legible, contemporaneous, original, and accurate — the ALCOA+ criteria. Deloitte produces compliance documentation. The documentation describes a theoretically ALCOA+-compliant system. The validation testing that confirms the system actually behaves as documented is the gap where most pharmaceutical technology failures originate.
Clinical trial data integrity is an area where Deloitte's consulting model creates specific risks. A Phase III trial with data integrity failures does not produce a warning from FDA — it produces a Complete Response Letter, a clinical hold, or a 483 observation that delays approval and triggers a remediation program that costs more than the original system. Deloitte has been engaged on both the original system and the remediation. That is not a record to be proud of.
What we deploy instead
Our pharmaceutical technology teams are qualified on FDA 21 CFR Part 11, GAMP 5 validation methodology, and the specific architecture of clinical and manufacturing systems that survive FDA inspections. We build validated systems, not compliant-looking systems.
Validation documentation is generated as part of the build process — not assembled after the system is complete. Every automated test is part of the validation evidence package. The audit trail is not a feature; it is the architecture.
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, HIPAA for patient data. The difference between a validated system and a system with validation documentation is the difference between passing an FDA inspection and receiving a 483 observation.
What switching from Deloitte 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 Deloitte engagement — from emergency stabilisation through full re-platforming. 4-phase playbook covering stabilise, assess, transition, and normalise.