Regulations mandate effective content control, and Contract Laboratory, Research or Manufacturing organizations recognise the need to have easy to use Document Management Solutions. For many employees, the requirement to access their DMS is a daily requirement and they need to have fast, easy access to an intuitive system that meets 21 CFR Part 11 requirements.
In the research and development areas, users need a solution that allows for strong collaboration capabilities, ensuring that authors and reviewers (both internal and external, sponsor or agency) 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 audited 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.
For more information on a Platform approach to Quality Management, download this webinar on QUMAS Quality Management Solution for Global Regulatory Compliance, or if you are interested in using Microsoft SharePoint as a QMS download this webinar on Extend your SharePoint platform as a QMS for Controlled Document & Quality Process Management.