IEC 62304 for Pharmaceuticals & Life Sciences
What IEC 62304 means for Pharmaceuticals & Life Sciences organizations — and how we implement it at the architecture level.
IEC 62304 in Pharmaceuticals & Life Sciences environments carries requirements that go beyond the framework's general provisions. The specific operations of Pharmaceuticals & Life Sciences organizations — their data processing scale, their regulatory relationships, and their operational dependencies — create compliance obligations that engineering teams must address at the architecture level. Generic IEC 62304 compliance that ignores the Pharmaceuticals & Life Sciences context will produce a system that passes audit by a framework-generalist but fails review by an industry-specialist examiner.
Our teams deploy in Pharmaceuticals & Life Sciences environments with IEC 62304 compliance built into the architecture from the first design decision. The compliance controls are not a layer added to an existing system — they are implemented as first-class components that generate evidence continuously as the system operates. The result is a system that is compliant on deployment day, remains compliant as it evolves, and produces audit evidence without manual assembly.
IEC 62304 compliance documentation maintained as live system artifacts, not annual documentation projects
Access controls that satisfy IEC 62304 requirements for Pharmaceuticals & Life Sciences data handling
Audit logging that generates evidence meeting IEC 62304 audit standards in Pharmaceuticals & Life Sciences regulatory contexts
Incident response procedures aligned to IEC 62304 notification and reporting timelines
Third-party vendor compliance documentation satisfying IEC 62304 supply chain requirements
We implement IEC 62304 compliance for Pharmaceuticals & Life Sciences clients by mapping the framework's requirements to the specific operational context of Pharmaceuticals & Life Sciences organizations before writing application code. Controls are implemented through infrastructure-as-code, enforced automatically by ALICE at every commit, and documented through automated evidence generation pipelines. The result is a IEC 62304-compliant Pharmaceuticals & Life Sciences system delivered on a fixed-price timeline.
Ready to build IEC 62304 compliance into your Pharmaceuticals & Life Sciences system?
We build compliance architecture for Pharmaceuticals & Life Sciences organizations — IEC 62304 and the full Pharmaceuticals & Life Sciences compliance landscape — from the first infrastructure decision. Fixed price. Production delivery. No discovery phase.