This event from the “Compliance without Complexity” Seminar series is focused on learning how SharePoint can be used to manage regulatory documents from initial creation through submission to the FDA.
During the one-hour online webinar, session leaders Jeff Steward of NextDocs and Warren Perry of EXTEDO talk about how the life cycle of a document that is part of a submission begins with its initial authoring and extends right through — and after — submission. To maximize efficiency and ensure compliance, it is vital that systems for managing submissions content be completely integrated and provide a defensible audit trail with version control and digital signatures through all phases of the process.
The session leaders explain how that type of integrated solution is possible using SharePoint. They talk about the critical success factors for an integrated solution, and look at an example based on SharePoint. In this free, one-hour session you will see how:
- The complete document lifecycle from initial authoring to post marketing can be managed with a Microsoft SharePoint-based solution
- Microsoft SharePoint can be configured to meet 21 CFR Part 11 requirements and a variety of other FDA and ISO regulatory directives and compliance standards
- How features such as workflow design, detailed auditing & reports, digital signatures, parallel review capabilities and PDF rendering are all available in a SharePoint-based solution
- You can effectively manage all of your publishing needs (legacy, paper, eCTD, CTD, medical device, and non-CTD regions) by integrating your SharePoint compliance solution with a submission management solution
CLICK HERE TO DOWNLOAD WEBINAR RECORDED on October 28, 2009
Ken Lownie, Vice President of Life Sciences, NextDocs
Presenters
Jeff Steward, Solution Architect, NextDocs
Warren Perry, Director of eRegulatory Strategies, EXTEDO
