For Life Sciences companies the regulatory landscape is constantly changing & with every change comes the increased risk of non-compliance.
You can build total quality into every stage of your product lifecycle in a way that empowers you to balance control and innovation confidently.
Leveraging quality as an asset rather than a constraint enables Life Sciences companies to improve the patient experience and outcome while reducing cost – a win win for all.
The goal is to adopt a risk based approach, leveraging data for predictability and creating an integrated framework for compliant innovation, embedding quality and regulatory best practices early in the development process, and providing end-to-end product traceability throughout the lifecycle of the product. This process allows for higher quality, compliant products and faster regulatory approvals.
Ensure full regulatory compliance to:
Enhance patient adherence, safety and experience
Improve patient outcomes
Reduce the cost of non conformance
The Medidata RBQM framework offers the right capabilities that Life Sciences companies need to execute a successful RBQM strategy. This framework provides a simple, easy-to-follow approach that highlights the best entry point for your organization.
An integrated framework for compliant innovation, with embedded quality and regulatory best practices will help meet the demands of both government regulators and patients while simultaneously demonstrating value and reducing costs.
Dassault Systèmes' Life Sciences industry solutions and the 3DEXPERIENCE® platform help consign disconnected, manual processes to the past for better efficiency and control, and total quality outcomes in the present. With the Dassault Systèmes 3DEXPERIENCE platform you can:
As drug development costs continue to rise, the Life Sciences industry is under increasing pressure to improve efficiency and increase operating speed. In this article, the Drug Information Association (DIA) discusses costing strategies for sustainable drug development in a session at the DIA conference chaired by Tufts Center for the Study of Drug Development's senior project manager Stella Stergiopoulos.
IDMP compliance requires that the information sent to regulatory agencies be consistent in format and ISO coding. This provides a significant opportunity beyond compliance: digital continuity can provide a competitive advantage to your pharmaceutical organization.
A comprehensive global approach to quality, regulation and compliance.
The 3DEXPERIENCE platform’s integrated business framework helps Osstem Implant eliminate traditionally disconnected processes and data, and increase the efficiency and accuracy of its product quality control.
Ferring’s strategic approach to content management BIOVIA QUMAS for an integrated content management solution
Korean health and medical materials and devices manufacturer Meta Biomed faces strict and complex checks before gaining regulatory approval on new products. It required a modern platform to centralize its product development data and support a more structured way of working to boost innovation and speed up certification as it aims to take the lead in the global surgical sutures market.
Discover Dassault Systèmes®' Life Sciences industry solutions aiming to improve patient and physician experience, and organizational business excellence.