There are many advantages. A qualified SharePoint environment is an excellent platform for storing and managing GxP critical documentation and processes within a familiar and intuitive Microsoft interface. It also provides significant Quality Management capabilities. Submission-ready pdf versions securely stored in a separate and dedicated repository; full audit trail; an eQMS with interlinked processes and procedures; tracking of document training… These are just some of the things that can be achieved on SharePoint.
The challenge: Relying on SharePoint for GxP critical content requires a qualified and compliant platform to support the business application layer. Do you know how to ensure the platform is qualified and ‘in control’ – and stays that way?
Epista can help. We’ve developed a proven methodology to qualify SharePoint environments and SharePoint cloud solutions for use in the regulated Life Science industry.
Ask us about our services:
- 21 CFR Part 11 compliance (from electronic signatures to audit trails)
- Understand and manage the requirements of Validation and System Lifecycle Management
- Regulatory, Quality and Compliance Management on SharePoint
- Leverage technology to extend the compliance capabilities of SharePoint using applications like ComplianceSP, X-Docs, and similar
- Compliant lifecycle management of controlled content
- Incident management including deviations and CAPAs
- Controlled Task Management
Get in touch. We enjoy sharing our knowledge and are happy to discuss advancing regulatory compliance in your company: