Global Operating System Upgrade & Computer System Validation for FDA Approved Facility

Biologics

Client Overview

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.
Client
Biogen
Location
Global: Durham, NC, Cambridge, MA, Denmark
Biologics

Life Impact

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Tulip

No Code App Development for Manufacturing Operations

Tulip creates user-friendly and functional apps that improve the productivity of operations, without writing any code. Users can start from scratch or customize an App Template to fit their needs.

Sequence partners with Tulip for implementation and validation of the Tulip platform as well as creation, configuration and validation of Tulip Applications that are hosted on the platform. Our application builds include Electronic Batch Records, Weigh and Dispense, Digital SOPs for training (with embedded videos) and more.