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[WHITEPAPER] SharePoint Configuration Guidance for 21 CFR Part 11

By  Jim Kane Jim Kane  on 2013-09-23 09:00:00  |  Featured in  Life Sciences , SharePoint
Jim Kane
Posted By Jim Kane
in Life Sciences in SharePoint
on 2013-09-23 09:00:00

Microsoft SharePoint provides a number of beneficial features to its users – features that have been improved upon and added to in the new SharePoint 2013 software edition. One of the most notable features of this web application platform is the compliance support that has been integral to SharePoint since the 2007 edition. Complying with regulations, such as 21 CFR Part 11, can pose some challenges without proper updates to ensure compliance capabilities within an organization’s electronic records system. This section of the Code of Federal Regulations establishes the standards for reliable and trustworthy electronic records and signatures for industries that are regulated by the United States Food and Drug Administration, including biologics developers, biotech companies, CROs, drug manufacturers and medical device manufacturers.

The whitepaper, “SharePoint Configuration Guidance Rev. 1.0,” offers insights from Paragon’s SharePoint consulting experts and from members of the team at Microsoft into the regulations that affect electronic records for these industries, and how SharePoint configurations can help organizations ensure compliance as we continue into the digital age.

What to Expect in “SharePoint Configuration Guidance”

While reading “SharePoint Configuration Guidance Rev. 1.0,” you will encounter two discrete sections that provide helpful information about how to accomplish successful SharePoint migration to ensure compliance with regulations such as 21 CFR Part 11. First, readers find a section that details examples of SharePoint configuration, the architectures that a company must have in place to support compliant electronic signatures, how they must configure their systems to accomplish this, what this looks like for the end user and how the end user will interact with the electronic signature functions. This relates specifically to complying with 21 CFR Part 11, and includes detailed, step-by-step directions for configuring the SharePoint system to be compliant with electronic signature standards, including the compulsory registry settings and codes, when applicable. The next portion of the whitepaper explains the regulation itself, and why it is so essential to utilize the SharePoint functions and available configurations to enable complete compliance with all of the standards detailed in the regulation. By the end, readers should better understand the compliance issues surrounding electronic records and signature regulations for life sciences industries, and the role of SharePoint integration services in accomplishing these goals.

Important Notes to Remember about Regulatory Compliance

While SharePoint consulting services can be very helpful in achieving compliance with 21 CFR Part 11, the software or hardware that organizations use to store electronic records and obtain electronic signatures will never be compliant itself. Compliance depends on the actions of the organization using the system at the end of the day, and the processes it goes through when implementing the software or hardware system. With a knowledgeable SharePoint consultant and a well-developed and implemented configuration plan, however, it’s possible to better prepare an organization for all the issues related to its compliance with regulations such as 21 CFR Part 11. This whitepaper offers individual examples of use cases, with different structural needs and considerations, and explains the compliance issues related to their SharePoint systems. Since there are different types of architectural approaches, there are many different types of considerations depending on how each organization sets up its SharePoint system. The three main architectural approaches include the following:

  • Office 365 Online, including Microsoft SharePoint
  • Service virtual machine in an Azure Infrastructure
  • Traditional SharePoint setup with software used on-site

Depending on which approach your organization uses, what part of the life sciences industry you operate in and what your specific needs and goals are, the configurations you need to make to your SharePoint system will vary. With guidance, however, you are much more likely to make the changes that keep you compliant well into the future.

Interested in learning more about how Paragon Solutions can help you with your SharePoint 2013 Configuration? Contact a Paragon SharePoint expert today.

Microsoft SharePoint 2013: An Overview
Jim Kane

Jim Kane

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Jim Kane is the Director of Collaboration and Knowledge Management (KM) at Paragon Solutions. Jim leads the KM practice with a focus on knowledge management and SharePoint-based solutions that support day-to-day business optimization via virtual problem solving, communities of practice, knowledge repositories, role-based communication portals, partner collaboration, and information dashboards. He is co-author of a patent, “Methods of Knowledge Management,” and has over 15 years of experience teaching at the college level as an adjunct instructor. Jim has presented at numerous regional and national conferences on the topics of Knowledge Communities, Adoption Strategies for SharePoint, and Global SharePoint deployments.

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