Founded in 1994, QUMAS is an established leader in enterprise compliance management with proven success in deploying regulatory compliance solutions to over 250 global pharmaceutical, biotechnology and medical device companies.
QUMAS provides a closed-loop compliance platform that enables you to integrate the common elements of compliance across your organizations, including content, processes, people and systems.
QUMAS solutions for document and quality management, submission management and regulatory approval enable you to accelerate your time to market, decrease compliance risks, improve operational efficiencies and reduce overall quality costs.
The QUMAS compliance platform
The QUMAS Compliance Platform is a closed-loop compliance solution that combines all of the elements of a cohesive and comprehensive regulatory solution on one platform. It delivers traditional capabilities around document and quality management, but also encompasses these with a unified user compliance interface, with learning management, and with consolidated reporting and dashboarding, all ultimately delivering better business performance.
Regulatory compliance solutions for life sciences - core capabilities
The Core Capabilities of the QUMAS Platform offer unique best practice compliance configurations, to provide a seamless combination of best practices across all of your compliance initiatives. These configurations include, but are not limited to:
- Quality & manufacturing documents
- SOP documents
- CAPA
- Deviation management
- Change control
- Customer complaints management
- Audit management
- R&D submission documents
- Corporate compliance
- Sales and marketing collateral
- Contract management
- ISO Management
- IT governance
QUMAS incorporates the controls, audit trails, permissions and structures that provide certainty on the following:
- That each piece of information is delivered to the right people
- Is reviewed or investigated on a timely basis
- Approved and signed off by the relevant managers
- Marked "read and understood" & is reflective of the intended meaning
- And is ultimately defensible against ongoing scrutiny, both internal and external
FDA 21 CFR Part 11 compliance
The QUMAS Compliance Platform provides a comprehensive framework to achieve sustainable compliance supporting the most stringent requirements such as: FDA 21 CFR Part 11; 210; 820; 600, ISO Standards (9000; 1400), GxP Practices.
Contact Details
QUMAS USA
66 York Street
Jersey City
NJ 07302
USA
Phone: 973 805 8600
Sales: 800 577 1545
Fax: 973 377 8687
Email: info@qumas.com
Web: www.qumas.com
QUMAS Europe
Cleve Business Park
Monahan Road
Cork
Ireland
Phone: +353 (0)21 4915100
Fax: +353 (0)21 432 0394
Email: info@qumas.com
Web: www.qumas.com
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