Although most software cannot be compliant by itself, the use of MOSS 2007 and other Microsoft technologies can be implemented as a component of a broader framework of policies, procedures, and other systems that are put in place by the implementing party.
 

Search Merit Solutions:

Microsoft Business Solutions
Business Intelligence
Data Management Solutions
SOA and Business Process

Home > Resources > White Papers > Guidance for 21 CFR Part 11 on SharePoint Server 2007

Guidance for 21 CFR Part 11 on SharePoint Server 2007

Compliance is a major focus area for Microsoft and the Office 2007 system. During design and development, specific attention was paid to features that enable regulated document management.

The following pages provide a table mapping of 21 CFR Part 11 sections to the Microsoft relevant technologies that can assist with compliance. This white paper will not only describe the regulation, but will also detail the specific features and configurations of SharePoint, Office 2007, Internet Information Server (IIS), Windows Server, Windows Rights Management Service, ASP.NET, and Active Directory, including actions to take along with example screenshots.

This white paper may also be helpful for validation purposes, including but not limited to: providing guidance in developing test plans, pointing out areas to test for proper configuration of the system, documentation of the steps taken when in an audit situation, and detailing the development methodology used in producing the Office 2007 system.

Fill out the form below for your white paper.
Your full name*:
E-mail address*:
Your telephone*:
Company name*:

* Required
Your message:
Pharma Nearing FDA Deadline
An integrated process for regulated content will help companies create, review, maintain and archive electronic submissions. Are companies ready?
The Key Competency for Growth
Optimizing information and collaboration will be the new key to winning or losing in Pharma.
Pharmaceutical Processing: Lots More Than Tracking!
Think that because you have strong controls for lot tracking and traceability you are fully compliant with FDA CFR 21 Part 11? Think again!
Manual vs Automated Compliance
YES, it’s time to take another look at compliance because the FDA’s swelling ranks give you new reason to do so.
Company    |    Products    |    Services    |    Industries    |    Resources    |    Contact Us

Merit Solutions, Inc.
1749 S Naperville Rd., Ste. 200, Wheaton, IL 60189
 info@meritsolutions.com (630) 614-7133
Follow Us Online:
Merit Matters Blog Merit Solutions on Twitter Merit Solutions on LinkedIn Merit Solutions in the Dynamics Community