Few industries are more tightly regulated than life science manufacturing.
Wonderware software helps implement optimal manufacturing practices that result in operational and process improvements while also simplifying compliance.
Whether producing pharmaceuticals, neutraceuticals, biotechnology or medical devices and equipment, life sciences manufacturing facilities must adhere to strict US FDA regulations such as 21 CFR Part 11, which requires that all manufacturing software have sound security procedures, done-by/checked-by capabilities and electronic signatures. Life sciences companies are often dependent on a handful of blockbuster drugs that are associated with the corporate brand so protecting brand integrity is absolutely critical.
In addition to meeting regulatory compliance and brand integrity requirements, life sciences companies must also ensure accurate execution.
They must follow Current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) and meet rigid operational standards. They must be prepared to produce accurate, reliable and tamper proof documentation and Electronic Batch Records (EBR).
The patent clock starts ticking from the day of filing and once a product is ready for market it must go into manufacturing quickly with volume scaled up to meet market needs. Wonderware operations modules standardize operations oversight, including batch recipe management, workflow software for SOP implementation and tools for production startup and variance reduction. This allows life sciences companies to go from lab to full-scale reduction quickly.
Fujirebio Diagnostics, Inc. provides biomarkers to help medical professionals better manage disease.
A major milestone was achieved at Fujirebio Diagnostics when the manual paper-based process of periodically recording temperature readings for specific GMP-related equipment was officially replaced by a new computerized system.
Cost Effectiveness with Wonderware
Compliance is not enough; life sciences companies must also be efficient and profitable. Wonderware solutions help record machine performance and downtime, collect and correlate production data and manufacturing information and track all materials and utilities used to help understand the cost effectiveness of operations.
Wonderware is the modern and low-risk operations management choice for life sciences manufacturing. We bring decades of industry experience and the broadest and most current software portfolio available anywhere. Virtually all major life sciences producers trust their business-critical operations to Wonderware software.
Wonderware has a broad set of offerings to help you achieve your goals. These include the following:
- Quality Management
- Process Workflow Management
- Operations and Process Oversight and Collaboration
- Data Collection, Reporting and Analysis
- Batch Recipe Formulation and Execution
- Line Performance Management