Medical Device 21 CFR Part 11 and HIPAA Compliant MS Sharepoint

21 CFR Part 11 Compliant Microsoft SharePoint and SharePoint Online Implementations

Medical Device and Pharmaceutical manufacturers shopping for an Electronic Document Management System are often greeted by high initial and renewal prices for software. Often these costs can be prohibitively high and businesses will put off implementation for years.

This scenario is complicated by a desire to store existing and past records in an easily searchable, indexed system even if these records are no longer actively undergoing revisions.

Fortunately, thanks to modern plugin development and market-available solutions, Microsoft SharePoint, and SharePoint Online, can now fill the role of an EDMS system with revision tracking, audit trails, and two-part authentication, while also serving as a system for securely storing old documents with excellent indexing and access tracking.

Sundial can provide a history of successful SharePoint solutions that perform well in an EDMS environment while complying with the crucial 21 CFR Part 11 standard.

21 CFR Part 11-compliant, customizable solutions are available for both the local, server-based install of SharePoint, and Microsoft’s excellent SharePoint Online. These solutions transform Microsoft’s classic document management system into a great platform for medical device companies.

SharePoint comes with many advantages over a standalone EDMS – chiefly its ease of integration into existing systems. Current network server file shares can be quickly converted into SharePoint repositories and SharePoint login/password structures can be integrated into Microsoft Active Directory (your current server system for processing login and passwords) or can be synced to the cloud through Microsoft’s Directory Sync. Both solutions should allow users to keep a current login and password when accessing SharePoint. SharePoint Online, and Office 365 in general, both support two-factor authentication through SMS passcodes to satisfy 21 CFR Part 11 requirements.

SharePoint uses a robust database system to track file versions, revisions, access history, outside access, and more. It is the industry standard system for version control that most aftermarket document systems are trying to mimic. SharePoint uses file repositories that can expand to a scale large enough for almost any document type (typically SOPs, BOMs, etc are each in their own repository).

One of SharePoint’s strongest advantages is Microsoft’s implementation of SharePoint Online through Office 365. Office 365 is Microsoft’s fastest selling, quickest-adopted enterprise product ever. Nearly all Office 365 subscription plans that include some downloadable version of the Office software include SharePoint Online. This means user access to the platform is already accounted for an integrated into your current monthly costs.

Like all EDMS systems, ROI comes through effective planning and quick implementation. A med device company, and its consultants, must work through expectations and requirements for the EDMS in a timely manner, and then move-on to customization, testing, implementation, and training.

21 CFR Part 11 modules for SharePoint include doc control systems for most standard medical industry doc types: SOPS, WIs, BOMs, CAPAs, FMEAs, NCRs, WOs, TRs, TPs, and more. Additional doc types can be added or removed as necessary. Most modules also include systems for tracking and running employee training, equipment management and more.

Cost is typically very affordable compared to stand-alone EDMS systems.

  Typical Implementation Schedule:
 Assess readiness to implement an 21 CFR Part 11 Compliant Microsoft SharePoint solution.
 Review current, market available SharePoint solutions for Med Device.
 Meet with Quality, Regulatory, Engineering, and Manufacturing departments about expectations of EDMS implementation.
 Determine if SharePoint or SharePoint Online is appropriate.
 Setup and configure SharePoint tenant.
 Work with departments to customize modules in test database.
 Pre-validate and validate functionality in test database.
 Copy to live SharePoint and rollout to users.


Does SharePoint run in the cloud?

SharePoint Online runs in the cloud, and is an excellent way to go to a cloud-based EDMS at low cost compared to standalone systems.

Can SharePoint accommodate any number of documents?

SharePoint will eventually run into limits on repository sizes. As long as your different doc types each live in their own repository it is hard to reach this limit.