The Landscape
FDA 21 CFR Part 11 compliance for pharmaceutical systems isn't a checkbox — it's an architecture decision made on day one. Validated computer systems, electronic records, and electronic signatures requirements mean every data pathway, every audit log, every change control must be designed into the system, not retrofitted after the FDA audit letter arrives. Most pharmaceutical IT projects discover this during validation — which is the wrong time to redesign your database schema.
Compliance bolted on after the fact costs 3x what compliance built in from the start costs. By the time the audit firm finds the gap, the architecture is already locked.
Our Approach
Compliance Coverage
Every system we deploy for Pharmaceuticals & Life Sciences in United States is FDA 21 CFR Part 11-compliant from architecture through deployment. FDA 21 CFR Part 11- and -HIPAA compliance is enforced automatically at every commit — not assessed after the fact.
Engagement Scope
Duration: 8–16 weeks
A focused team of 10–30 engineers deployed against a single Pharmaceuticals & Life Sciences platform in United States. FDA 21 CFR Part 11 + HIPAA-compliant architecture from day one. Fixed price, fixed output, no discovery phase.
Duration: 3–9 months
40–100 engineers running parallel workstreams across a Pharmaceuticals & Life Sciences transformation in United States. Multi-system compliance governance, integrated delivery management, and FDA 21 CFR Part 11 + HIPAA certification maintained across the entire program.
Duration: 6–18 months
100–250+ engineers owning the complete technology infrastructure for a Healthcare organization in United States. Full FDA 21 CFR Part 11 + HIPAA compliance across every system, every integration, every deployment — from the first commit to the final sign-off.