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 CFR 21 Part 11 regulatory requirements. Combined with preconfigured solutions for managing document, 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 Office, Outlook and Silverlight.
QUMAS ComplianceSP Modules
Each QUMAS ComplianceSP module offers a unique set of best practice compliance configurations, and is fully integrated with the wider ComplianceSP offering, to provide a seamless combination of best practices across all of your compliance initiatives. These modules include:
- Quality & Manufacturing Documents
- SOP Documents
- CAPA & Deviation Management
- Change Control
- Customer Complaints Management
- R&D Submission Documents
- Corporate Compliance
- Sales & Marketing Collateral
- Contracts Management
- ISO Management
- IT governance
QUMAS ComplianceSP adds the following Compliance capabilities to SharePoint2010/2013:
ComplianceSP Core Capabilities cover:
- FDA 21 CFR Part 11 compliance for electronic signatures (native capability, not third party intergraded capability) and audit trail.
- Full lifecycle state management, controlling documents through their lifecycle of create, review, edits, approve, release and distribute.
- Controlled content creation based on configurable document templates with workflow automation, auto-naming and metadata support.
- Extended SharePoint 2010/2013 Audit Trail to provide full traceability and accountability – including who viewed, reviewed and approved documents, key decision points and sign-off on compliance processes.
- PDF renditions, including watermarking and overlays , providing permissions-based access to relevant formats of content for viewing and printing.
- Electronic forms for automation & processing of regulatory events such as CAPAs and Deviations.
- Configurable Segregation of Duties to ensure that only the appropriate users can access certain information and carry out particular compliance tasks.
- Compliance Process Visualizations ensure end-users can full leverage best-practice compliance configuration.
- A ‘Compliance Center’ that exposes all relevant compliance information for instant decision making.
- Fully integrated with the SharePoint 2010 & 2013 environment, leveraging and extending the default SharePoint user experience.
- Automated Notifications via Microsoft Outlook, as well as in the ComplianceSP Task List, to ensure critical tasks are addressed in real time.
- Purpose-built Compliance Map, allowing a compelling visualization and exploration of all data and relationships in your compliance universe.
- Architected and Designed for large-scale, enterprise-level usage.
Review this analyst coverage:
For more information and demonstrations of QUMAS ComplianceSP on SharePoint 2010, download the following webinars:
- Leveraging SharePoint as a QMS for Quality Documents & Quality Processes
- Combine Best Practice with SharePoint 2010 for Quality Management across SOPs, Deviations & CAPAs
- Qualifying SharePoint 2010 and Delivering a 21 CFR Part 11-Compliant Quality Management Solution
- Leverage SharePoint to Control Content & Collaboration across your Global Supply Chain