How does AVEVA support a paperless electronic initiative in pharma?
At Fujirebio Diagnostics, AVEVA System Platform, Work Tasks, Historian and InTouch HMI replaced paper records with a compliant digital infrastructure. Equipment data is acquired automatically, structured into electronic reports and submitted for digital review and approval. This digitalization eliminates the risk of data entry errors, ensures FDA compliance and drastically speeds up the review process, which has gone from 15 hours to just a few minutes.
What role does AVEVA Work Tasks play in biomarker manufacturing?
AVEVA Work Tasks structures and digitizes Fujirebio Diagnostics' operating procedures, ensuring that every critical step in biomarker manufacturing is carried out in line with quality and regulatory standards. Operators follow guided workflows, record their interventions and trigger reviews automatically. This task orchestration is a standard in the life sciences, where GxP traceability is a non-negotiable requirement.
How can 1,100 person-hours per year be saved thanks to AVEVA Historian?
AVEVA Historian automates equipment monitoring at Fujirebio Diagnostics, eliminating the time-consuming manual review of reports. Critical parameters are recorded continuously, analyzed automatically and only alert teams when there is a deviation. This shift from reactive checking to exception-based monitoring frees up 1,100 person-hours per year, the equivalent of about 0.5 FTE, who can focus on tasks of greater scientific value.
How can FDA compliance be maintained in a bioproduction environment?
FDA compliance requires full traceability, validated electronic signatures and impeccable data integrity. AVEVA System Platform and Historian provide the technical infrastructure: automatic recording of critical parameters, a complete audit trail and secure access. For Fujirebio Diagnostics, this automation turned compliance from a time-consuming constraint into a natural by-product of operations, ensuring the regulatory robustness that is essential in the life sciences.
How did an electronic initiative help Fujirebio produce 75 million tests?
The production of 75 million tests at Fujirebio Diagnostics is made possible by the smooth operation of the AVEVA electronic infrastructure. Cutting data review from more than 15 hours to a few minutes drastically speeds up the batch release cycle. This ramp-up in throughput without compromising quality illustrates the added value of modern industrial monitoring in very high-volume regulated manufacturing.
