Teams at Agilisium Consulting

Conduct advanced data analytics to identify bottlenecks, reduce errors, accelerate batch release, and improve manufacturing reliability. Gather and document business requirements, create process flows, and support solution implementation. Design and validate GxP-, GMP-, GCP-, and FDA 21 CFR Part 11-compliant systems, including AWS-based digital platforms for Cell and Gene Therapy manufacturing. Develop APIs, microservices, automation solutions, and secure digital prototypes supporting regulated operations and real-time data visibility.

Lead development and implementation of CSV/CSA strategies for GxP-regulated systems. Provide technical/regulatory guidance, oversee lifecycle validation, author and approve validation deliverables, conduct impact assessments, maintain distribution quality processes, and optimize technologies to ensure data integrity, traceability, audit readiness, and regulatory compliance.