Machine Learning / AI engineering for Pharmaceuticals & Life Sciences
Production Machine Learning / AI built for the compliance reality of Pharmaceuticals & Life Sciences. Not generic engineering adapted to your sector — sector-native architecture from the first design decision.
Pharmaceutical and life sciences Machine Learning / AI deployments must satisfy FDA 21 CFR Part 11 alongside HIPAA when the systems touch electronic records used in FDA-regulated activities — clinical trial management, manufacturing execution, lab information systems. Part 11 requires validated systems: every Machine Learning / AI application used in these contexts must be formally validated through IQ/OQ/PQ to demonstrate it consistently meets its specifications. This is not a documentation exercise — it requires the Machine Learning / AI architecture to be designed for validation from day one.
The intersection of Part 11 and modern Machine Learning / AI cloud deployments creates specific engineering obligations. When a Machine Learning / AI application runs on cloud infrastructure, the system must demonstrate that the cloud provider's underlying infrastructure provides the audit trail, access controls, and data integrity controls Part 11 requires — or the application must implement these controls itself. Our teams architect pharma Machine Learning / AI systems with this distinction resolved from the first infrastructure decision, not discovered during validation.
Pharmaceuticals & Life Sciences engineering operates under a specific set of regulatory frameworks that govern data handling, security controls, audit requirements, and system availability. Every Machine Learning / AI architecture decision we make in this sector is evaluated against these frameworks — not added as a compliance layer afterward.
Computer System Validation planning before architecture is finalized — IQ/OQ/PQ traceability built into the design
Electronic signature and audit trail implementation in Machine Learning / AI to satisfy Part 11 requirements
De-identification validation gates in data pipelines — PHI never reaches ML training infrastructure
Validation-ready documentation generated as a byproduct of the build process
Our Pharmaceuticals & Life Sciences case studies include Machine Learning / AI technology deployed in production — compliant from architecture, delivered on fixed-price timelines. Not proof-of-concept work. Production systems serving regulated organizations.
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We deploy engineering teams that build Machine Learning / AI systems compliant with FDA 21 CFR Part 11, HIPAA, SOC 2 from the first architecture decision. Fixed price. No discovery phase. Production delivery.
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