QUMAS has over 15 years experience in highly regulated industries, providing world class compliance solutions to over 250 customer deployments (some with 120,000+ users), including seven of the top 10 pharmaceuticals, four of the top ten biotechs, and five of the top ten medical device companies, as well as leading financial services firms.
The company's R&D headquarters are located in Cork, Ireland, with European sales offices in Dublin and Geneva. The company also has a US headquarters in New Jersey and USA sales offices in New York and Boston.

QUMAS Solutions Overview

The QUMAS Compliance Solution consolidates and standardises regulatory compliance into a comprehensive framework that eliminates the cost of managing disparate and isolated applications. The three main elements of all QUMAS Solutions are:

• QUMAS DocCompliance - regulatory content management for electronic control of all documentation throughout the product lifecycle from R&D and trials, to manufacturing and sales & marketing
• QUMAS ProcessCompliance - workflow and process management for Deviations, CAPA, Change Control, Audit and so on
• MyQUMAS - web-based single point of access for monitoring and responding to all compliance activities

QUMAS also offers a number of pre-defined Packaged Solutions. 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. Packaged Solutions, such as the QUMAS Quality Assurance Documents Package, QUMAS R&D Submission Documents Package or QUMAS Change Control Process Package, are scalable solutions that grow as the company grows, ensuring successful on-boarding while maintaining document control and regulatory compliance.

Benefits of QUMAS Packaged Solutions

Qumas Packaged Solutions,enable companies to get up and running with working solutions quickly and without long consulting engagements or expensive customisations. With a minimal upfront cost, every organisation, no matter how small, can have access to world class solutions.

• are ready to use out of the box and can be implemented, validated, and trained for go live all within 30 days. All of the configurations, materials, wizards and documentation required are supplied with the system.
• are pre-defined and pretested and are backed with 15+ years of experience in delivering compliance solutions to small and large pharmaceutical, biotechnology, and medical device companies
• meet GAMP 5 Category 3 definitions, making them significantly easier to validate and deploy

QUMAS has an active user community (QUCOMM), chaired by Dr. Joerg Stueben of Boehringer Ingelheim, and client satisfaction is clearly expressed in the following client quotes:
Janssen (J&J): "We chose QUMAS because its comprehensive compliance suite uniquely allowed us to install a single solution that we would previously have sourced from two or more vendors. The QUMAS Compliance Suite provides the company with a scalable compliance framework that can be rapidly rolled out across multiple divisions."

• NAPP Pharmaceuticals: "In addition to being the right solution that best met our user and technical requirements, QUMAS was the clear leader in terms of quality."
• HGSI: "We were under budget with this project and currently have over 700 employees under secure and controlled access using the system. We've achieved 100 percent better efficiency."
• OSI Pharmaceuticals: "With QUMAS, approval processes that might previously have taken weeks as a paper document circulated among multiple executives are now done in a day."
• Siena Biotech: "We were in the market for a flexible and up-to-date system for document management and found QUMAS Solutions to be the ideal fit for our organization, allowing the system to grow with the portfolio of the company."
• Chiesi Farmaceutici: "QUMAS was able to deliver an off-the-shelf compliance content management solution that is configurable to meet all our requirements. The QUMAS solution enables us to improve our time to market and to provide the regulators with better quality submissions, ensuring timely approvals."

Qumas sells directly to end-users as well as indirectly through resellers in the U.S., Germany, the Nordic regions and Italy. For more information visit www.qumas.com