Key to the success of any Generics or API manufacturer today is a single, unified repository to act as a location of record for everyone involved in the development, supply chain, manufacturing, and Quality or Regulatory roles within the organization. This repository must be accessible around the world and around the clock. Both Generic and API manufacturers are part of a complex supply chain that requires the efficient creation, review, approval and consumption of large amounts of proprietary content.
The security of this Intellectual Property is vital to a company’s long term success, however getting it into the hands of those who need it to do their jobs is equally important. This can require Extranet Portals, secure VPN access and simultaneous access to content from every manufacturing location around the world. Secure web access is the proven method for delivering on all these requirements.
QUMAS Electronic Document Management
A Document Management Solution is critical to ensure regulatory compliance. For many employees, the requirement to access their DMS is a daily requirement. They are required to have fast, easy access to an intuitive system that is compliant with 21 CFR Part 11 requirements.
In the research and development areas, users need a solution that allows for strong collaboration capabilities, ensuring that authors, reviewers, both internal and external are in a position to comment and make their proposed changes to the content of their documents. These documents will often be used in submissions and must therefore follow pre-approved templates and be rendered to submission ready PDF formats.
In the quality assurance areas, users need a solution that allows for strong version control and distribution of SOPs to ensure that only the latest versions are in circulation and users are properly trained on the correct procedures. These documents may require printing in which case strict print controls become an important feature as well.
QUMAS delivers a world class electronic document management solution that is recognized as an industry leader. Watch these webinars to learn more about the changes in the regulation of the Generics Industry, and how QUMAS can help you to address them: