Global Operating System Upgrade & Computer System Validation for FDA Approved Facility
Biogen Inc. is a biopharmaceutical company that focuses on discovering, developing, manufacturing and delivering therapies to people living with serious neurological, rare and autoimmune diseases.
Sequence Scope: Computer System Validation
To ensure security and business continuity, the client requested a plan for a multi-site, global QC Operating System (OS) update of all their lab systems to a single platform. Computer system validation services for FDA approval were required to ensure compliance and data integrity of each system being upgraded. Sequence generated computer system validation lifecycle documentation for over 80+ lab systems across 3 sites (Cambridge, RTP, and Denmark), including project management services and strategic testing strategies for global harmonization. The team performed reviews of software configuration and provided recommendations for compliance with 21CFR11 & Eudralex requirements, while ensuring all operational and functional requirements are met. The scope also included support for data backup process and system integration to NuGenesis. The project was completed as scheduled.
Biogen is making advancements in pharmaceutical manufacturing and medical research programs. Its active research includes treatments for conditions like multiple sclerosis, spinal muscular atrophy and other serious neurological conditions.