Pharmaceutical and Biotech Organizations recognize that by going paperless they will need to be 21 CFR Part 11 and Annex 11 compliant in all areas: IT infrastructure, SOPs, software product features and so on. The benefits of an electronic system are an immediate improvement in productivity and a significantly lower risk of 483 Warning Letters or non-conformances.
In using the QUMAS Compliance Platform, Organizations can be confident that they are complying with CFR Part 11 as well as Annex 11 in completing Electronic Signatures and utilizing a fully compliant electronic audit trail that supports point in time reporting.
To learn about the core components of a fully compliant QMS solution, that can deliver business efficiencies as well as regulatory control, download the webinar - QUMAS Quality Management Solution for Global Regulatory Compliance
If you are interested in SharePoint and 21 CFR Part 11, download this webinar on Extend your SharePoint platform as a QMS for Controlled Document & Quality Process Management