PLM Vivo for BioPharma
Rapid Deployment Product Lifecycle Management
In the biopharma industry, comprehensive and easily accessible product lifecycle data is essential to the management of regulatory processes that often cause delays in the launch of new drug products. Biopharma companies rolling out new products or changes to existing products must meet strict regulatory guidelines around product safety and efficacy, as well as adhere to Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
A management discipline called product lifecycle management (PLM) is an effective approach to help navigate these challenges. PLM is the process of managing the entire lifecycle of a product – from its conception, through discovery, development, regulatory approval, to launch, production and end-of-life.
For biopharma companies, this means linking the “world of science” with the “transactional world” by transforming and enhancing scientific and experimental drug information into descriptive drug product master data. Read more about PLM in biopharma.
Traditionally, deploying a PLM solution can take anywhere from 20 weeks to over 35 weeks - and beyond. To help to begin the PLM journey faster and at a lower price point, Kalypso's cost-effective alternative, PLM Vivo for BioPharma, can help companies to quickly realize the benefits of PLM.
Featuring pre-defined security models, workflows, document templates, advanced search and reports, PLM Vivo for BioPharma offers the most effective and efficient PLM delivery for biopharmaceutical companies, enabling:
- A single version of the truth for all product data and information
- Visibility to enable event-driven portfolio decisions and timelier re-allocation of funding and resources
- Traceability to maintain compliance, address regulatory inquiries and improve knowledge reuse
- Reduction of alidation and regulatory compliance costs
- Reduction of compliance risks through global coordination of packaging and labeling processes
- Cycle time reduction and time to market through standardization of processes and tools