SOLABS QM and Sharepoint ; e-QMS software integrated to SharePoint

Context

SOLABS QM & SharePoint

The Microsoft SharePoint collaboration platform has gained more and more attention over the years and will continue to grow in enterprises.

If your company is already using SharePoint or plans on implementing the platform and you are in the following situation:

You work in a Gxp environment
You are regulated and may be audited by FDA and/or other regulatory bodies
You wish to circulate and control documents and forms in an electronic fashion
You must achieve 21 CFR part 11 compliance

Then your organization will need to consider and address some of the key elements that are not present in an out-of-the-box SharePoint implementation:

Compliancy to FDA 21 CFR part 11 regulations
Maintainance of a compliant audit trail (vs a standard version history)
Implementation of complex workflows such as CAPAs, Change Controls, Deviations, etc.
Validation effort according to GAMP guidelines
Training record management

And how can you address these key elements that are not out-of-the-box with SharePoint?

You may:

Customize, configure and program in SharePoint
Configurate and customize via add-ons
Integrate with an e-QMS system such as SOLABS QM

Option 3 offers a painless SOLABS QM/ SharePoint integration while allowing you to focus energy on corporate-wide deployment of SharePoint, as opposed to a strictly GxP deployment.

The following is an overview of how the functions are segregated between SOLABS QM and SharePoint:

Segregation of roles between Solabs QM and Sharepoint