Generic Drug and API manufacturing organizations are mandated to have effective content control by regulators and must have easy to use Document Management Solutions. For many employees, the requirement to access their DMS is a daily requirement and they are required to have fast, easy access over an intuitive system that is compliant with 21 CFR Part 11.
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.
The QUMAS R&D Content Management Solution enables Generics to manage content from early trial phases, through the creation of an eCTD structure, and integrates with leading publishing solutions for ANDAs electronically to the relevant authorities.