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.
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
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.