BEACHWOOD, Ohio - Kalypso, the world’s premier innovation consulting firm, today announced PLM Vivo for BioPharma and PLM Vivo PRO for Product Registrations, pre-configured product lifecycle management (PLM) solutions designed for rapid implementation in biopharmaceutical companies.
“To successfully innovate in a complex industry environment, biopharma companies must adopt a holistic lifecycle perspective to innovation,” said Horst Groesser, partner at Kalypso. “PLM puts a biopharma company’s most valuable innovation asset – product data – at the center of their innovation efforts.”
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.
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). These companies must keep careful product registration records as evidence that the product has been manufactured and tested correctly.
PLM Vivo for BioPharma enables companies to capture and quickly access the product lifecycle data necessary for meeting regulatory guidelines. Built on Oracle’s Agile PLM application, biopharma companies can go live with this PLM solution in as little as 16 weeks while simultaneously reducing the risk and cost relative to traditional PLM delivery. 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.
“Biopharma companies face serious risk, costly delays and fines if they fail to adhere to strict FDA regulations,” said Groesser. “Achieving and maintaining regulatory compliance as quickly and efficiently as possible is vital if a biopharmaceutical company is to remain competitive. With PLM Vivo for BioPharma, companies will be able to reap the benefits of PLM with minimal investments of time and other resources."
Biopharma companies will also be able to enhance the standard PLM Vivo for BioPharma package with PLM Vivo PRO for Product Registrations, gaining more comprehensive functionality to manage their product registration processes. PLM Vivo PRO for Product Registrations features:
- An extended data model supporting international product registrations
- Templates for commonly required documents
- Pre-configured international product registration process integrated with product release process
- Pre-defined workflows based on leading submission practices
Kalypso is a Gold level member of the Oracle® PartnerNetwork (OPN) and has achieved the Oracle PartnerNetwork Specialization for Agile Product Lifecycle Management. Kalypso offers several specialized rapid deployment PLM solutions across a number of industries including medical device, food and beverage, retail, quick service restaurants, and semiconductor.
Kalypso is the world's premier innovation consulting firm, helping clients improve performance, drive profitability and create sustainable results by delivering on the promise of innovation. The people of Kalypso are leading business professionals who combine unparalleled expertise in innovation, product development, and product lifecycle management (PLM) with a depth of experience in the consumer goods, high technology, manufacturing, life sciences and retail industries.