Qualifying SharePoint for Use in Life Science Regulatory Environments

Content management solutions based on the Microsoft platform enable collaboration among global teams in a highly secure, compliant environment. Whether you choose to deploy within your enterprise, or within the Cloud, you can easily create, store, and find relevant documents in a central repository that meets FDA regulations and security requirements. This can increase the efficiency of the research process and help your company be more competitive. Learn more about the process of qualifying SharePoint 2010 and 2013 against Title 21 CFR Part 11 and Annex 11 to achieve those goals.

The discussion will include:

  • Overcoming perceived operational challenges of the SharePoint infrastructure in regulatory environments
  • Gaining control of the SharePoint platform
  • Understanding and managing the requirements of validation
  • Overcoming regulatory compliance challenges in SharePoint
  • How the DeltaPoint governance solution ensures consistency during operation and maintenance of the SharePoint farm and its application
  • Live Q & A session

Presented by USDM Life Sciences and epista IT:
USDM Life Sciences and epista IT have extensive experience qualifying SharePoint and Office 365. The two companies leveraged their knowledge of government regulations and industry best practices to develop SharePoint and Office 365 qualification packages that help life science companies save time and money on the compliance process. 

About the Presenter:
Klavs Esbjerg holds a degree in Chemical Engineering from the Technical University of Denmark as well as a management degree from Scandinavian International Management Institute. Since 1997, Klavs Esbjerg has gained substantial industry experience at various levels by working as a consultant, as responsible for validation, as a project manager, a sales director and even at the senior management level in large consulting and delivery organizations. Klavs Esbjerg has worked exclusively with deliveries of various IT systems to Life Science companies. In 2009, Klavs Esbjerg co-founded epista IT and is currently managing the company with full responsibility for sales, delivery, personnel and the company’s expansion.

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  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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