Complete Document & Quality Management Solution for Life Sciences on SharePoint 2010 & 2013
QUMAS ComplianceSP on SharePoint 2010 & 2013 is an innovative document and quality management solution, combining the power of SharePoint with the proven regulatory domain expertise of QUMAS. Collaboration is a core element of electronic document management and QUMAS extends this key SharePoint capability to ensure full compliance with FDA's 21 CFR Part 11 regulatory requirement. Combined with pre-configured solutions for managing documents, processes, people and tasks, ComplianceSP on SharePoint delivers a unique and verifiable solution to all of your regulatory requirements on the latest technologies.
QUMAS ComplianceSP is fully web-based, ensuring anytime/anywhere access to your critical compliance activities, all secured by role and permission based access. It integrates seamlessly and leverages the wider Microsoft environment, including including Word, Excel, Outlook, etc.
QUMAS ComplianceSP Modules
ComplianceSP delivers unique and verifiable solutions that provide pre-configured software for managing documents (SOPs), processes (CAPA, Deviation, Change Control, Complaints) and tasks on SharePoint. ComplianceSP is fully web-based, ensuring anytime/anywhere access to your critical compliance activities, all secured by role and permission based access. It integrates seamlessly with the wider Microsoft environment, including Word, Excel, Outlook, etc.
QUMAS ComplianceSP adds the following Compliance capabilities to SharePoint2010/2013:
ComplianceSP Core Capabilities cover:
- Full Enterprise Content Management including document check-in/check-out, version control, enterprise-level security, integrated Active Directory, rich metadata and document tagging, advanced search capabilities and more
- Rich Collaboration environment for exchanging documents and data and supporting co-authoring, document approval and distribution
- Comprehensive Document Lifecycle Workflows providing configurable control of documents throughout their lifecycle of create, review, edit, approve, release and distribute
- 21 CFR Part 11 Support including Electronic Signatures (Figure 2), extensive Audit Trail, Controlled Tasks, Read &
- Understood with user verification providing Irrefutable Accountability
- Extended Audit Trail to provide full traceability and accountability – including who reviewed and approved documents, key decision points and sign-off on compliance processes
- PDF Renditions, including watermarking and overlays, providing permission-based access to relevant formats of content for viewing and printing
- Electronic Forms for automation & processing of regulatory events such as CAPAs, Deviations, Complaint Handling and Change Control
- Configurable Segregation of Duties to ensure that only the appropriate users can access certain information and be selected to carry out particular compliance tasks
- ‘Compliance Center’ (Figure 3) that contains and displays all relevant compliance information for instant decision making
- Controlled content creation using configurable document templates with workflow automation, auto-naming and metadata support
- Tight integration with both SharePoint 2010 & 2013, leveraging and extending the default user experience
- Integration to leading Submission Management publishing tools for Regulatory Affairs, with built in templates
- Automated Notifications, Reminders & Escalations via e-mail, to ensure critical tasks are addressed
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For more information and demonstrations of QUMAS ComplianceSP on SharePoint 2010/2013, download the following webinars: