GxP & 21 CFR Part 11 Compliance

To go paperless, Medical Device organizations 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, they 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.

If your organization is aiming to go paperless, download this informative webinar Why does your organization need an electronic Quality Management System?, which outlines how a complete QMS contains capabilities ranging from Document control through Quality processes and Learning Management, in one centralised interface.

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.