QUMAS lead in Compliance and Quality Management Software Solutions with more than 260 global customers and 20 years’ experience within Life Sciences. We provides a closed-loop Compliance Platform integrating the common elements of compliance, content, processes, people and systems across the organization. QUMAS Solutions for document, quality and incident management, submission management and regulatory approval, enable organizations to accelerate time to market, reduce compliance risks, improve operational efficiencies and reduce quality costs. We are a Gold Microsoft Partner, providing the QUMAS Compliance Platform on SharePoint 2010, Documentum, Oracle or SQL.
The QUMAS Compliance Platform
• Provides a closed-loop compliance & quality management solution, combining all elements of a comprehensive regulatory compliance program, on one platform
• Delivers full capabilities around document & process management
• Is accessed through a unified compliance user interface
• Provides just-in-time learning management
• Presents consolidated reporting & dashboards
Core Capabilities include:
• 21 CFR Part 11 compliance for electronic signatures and audit trail
• Full document lifecycle state management
• Controlled content creation based on configurable document templates with workflow automation, auto-naming and metadata support
• Full traceability and accountability – including who viewed, reviewed and approved documents, key decision points and sign-off on compliance processes
• Electronic forms for automation and processing of regulatory events such as CAPAs, Deviations, Change Control etc.
QUMAS offers proven regulatory compliance software solutions that help our Life Sciences customers to comply with global regulatory requirements. By choosing the QUMAS Compliance Platform our customers reduce the number of point solutions that need to be implemented and maintained, reducing costs and ultimately delivering enhanced business performance. The QUMAS Platform is easy to implement, easy to validate and easy to use.
QUMAS also offers a number of Packaged Solutions providing pre-defined and pre-tested configurations of Document content management or Process management for specific,common industry problems. Each Package is designed to address a specific business function and includes all required software, implementation services, training, and documentation to support that business function. Packages may be combined and built upon over time as company requirements grow.
QUMAS is ISO 9001: 2008 certified and has an extensive install-base of referencable clients. We have been audited by independent organizations such as the Parental Drug Association (PDA) and many of our leading clients. Customers frequently audit our systems against strict quality standards and guidelines, and we welcome the opportunity for independent audits by our clients. QUMAS has been successful in all customer audits to-date. Our quality assurance processes and software development methodology are based on the highest standards in the industry.
Microsoft Gold Partner, ISO 9001:2008
• Technology • Software • Life Sciences • Compliance, Legal & Regulatory • Bio Pharmaceutical • Research & Development
• Boehringer Ingelheim • GlaxoSmithKline • MedImmune
• Takeda Pharmaceuticals • Actavis • Chiesi • EirGen
• Millennium Pharmaceuticals • Vertex Pharmaceuticals
• Purdue • Vistakon • Aspen Pharma • Samsung Biologics
• Hollister • Shire Pharmaceuticals • Janssen • Basilea
• Sigma Aldrich • Regeneron • Lantheus Medical Imaging
United States of America, Europe, South Africa, Asia
• Microsoft • Oracle • Lexis Nexis • Cegedim • EXTEDO
• Focused Consulting • US DataManagement • epistaIT
• CTCLS • Adlib Software
Cleve Business Park
Last updated on : 1/4/2012
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