SharePoint Online Compliance & 21 CFR Part 11 Validation Guide
Question details
The user needs to locate Microsoft documentation regarding SharePoint Online compliance, specifically GxP, SOC reports, and FDA 21 CFR Part 11 validation.
- Product
- SharePoint Online
- Device & OS
- not provided
- Scenario
- Searching for IQ, OQ, PQ validation documentation and SOC certificates for organizational regulatory compliance.
- Observed behavior
- The user needs to access restricted compliance documents and understand how Microsoft's audits apply to their FDA 21 CFR Part 11 obligations.
Ensure you have an active Microsoft 365 administrative or compliance role account, as accessing specific audit reports requires authentication in the Service Trust Portal.
Retrieve Compliance Documentation via the Service Trust Portal
Use the Microsoft Service Trust Portal to access and download SOC reports, GxP guidelines, and FDA 21 CFR Part 11 documentation.
Microsoft's enterprise cloud services undergo regular third-party audits for SOC 1 Type 2, SOC 2 Type 2, and ISO certifications. While these audits do not specifically focus on FDA compliance, they align with 21 CFR Part 11 objectives to ensure data security. Note that these reports describe Microsoft's controls and do not replace your organization's own IQ, OQ, PQ, or risk assessment procedures.
Open your web browser and navigate to the Microsoft Service Trust Portal (servicetrust.microsoft.com).
Click the 'Sign in' button at the top right and enter your Microsoft 365 administrator or compliance credentials.
Navigate to the 'Audit Reports' section from the main menu to search for and download SOC 1 Type 2 and SOC 2 Type 2 certificates.
Go to the 'Regulatory Compliance' or 'Healthcare and Life Sciences' categories to find specific whitepapers and blueprints regarding GxP and FDA CFR Title 21 Part 11.
Select the relevant documents and click the download icon to save them for your organization's independent validation and assessment procedures.
Try WPS Office for Your Documentation Needs
While managing compliance in SharePoint Online, you can use WPS Office to create, edit, and review your standard operating procedures (SOPs) and validation plans. It is a highly compatible, free alternative to Microsoft Office.
- 1. Visit the official site: Go to the official WPS Office website to access the free installer.
- 2. Download the software: Click the 'Download WPS Office Free' button to save the installation file to your device.
- 3. Install and launch: Run the setup wizard and open WPS Writer, Spreadsheet, or Presentation to start drafting your compliance documents.
Frequently Asked Questions
Does Microsoft provide IQ/OQ/PQ documentation for SharePoint Online?
No. Microsoft provides SOC reports and service control documentation, but they do not provide Installation Qualification (IQ), Operational Qualification (OQ), or Performance Qualification (PQ) documents. Organizations must perform their own validation based on their specific configurations.
Are Microsoft Cloud Services certified for FDA 21 CFR Part 11?
Microsoft does not offer a direct certification for FDA 21 CFR Part 11. However, their ISO, SOC 1, and SOC 2 audits share similar data security objectives, which support customers in achieving their own compliance.
Where can I find the SOC 1 Type 2 and SOC 2 Type 2 certificates?
You can download these certificates by logging into the Microsoft Service Trust Portal using your Microsoft 365 credentials and navigating to the 'Audit Reports' section.
