Since 1994 QUMAS has been delivering proven regulatory,quality and compliance solutions to pharmaceutical, biotechnology and medical device companies, enabling them to successfully address global regulatory challenges across the lifecycle of product research, development, manufacturing and corporate compliance.
QUMAS is the recognized leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 280 global customer deployments and domain expertise focused on regulatory compliance.
QUMAS was acquired in December 2013 by Accelrys Inc., who was in turn acquired by Dassault Systèmes in April 2014. Combined, Accelrys and QUMAS are now BIOVIA from Dassault Systèmes, providing a scientific collaborative environment for advanced biological, chemical and materials experiences.
QUMAS Awards, Certifications and Recognitions
- Microsoft Gold Certification for Content Management 2011, 2012 and 2013
- Deloitte and Touche ‘Best Managed Company’ 2010 and 2011
- it@cork Leaders Award for Research & Innovation 2014
- Irish Software Association ‘Collaboration of the Year’ Award 2008 and 2010
- CEO Kevin O’Leary short-listed as ‘Entrepreneur of the Year’ by Ernst and Young in 2009
- Successfully passed 100+ audits by clients
- 15 years of ISO certification, currently ISO 9001:2008
- Member of ISPE GAMP
QUMAS Quality Statement
Our commitment to quality is unparalleled in the compliance industry, and we are one of the few vendors in our market who are ISO 9001:2008 certified. Evidence of our commitment to quality, our voluntary certification through ISO also means that we have developed a quality management system that can be used for internal and external software development initiatives. QUMAS compliance with ISO 9001:2008 ensures that we take a process-oriented approach during the development, implementation, and continuous improvement of the quality management systems we use to meet our customers' exact requirements.
Serving clients in regulated environments necessitates adherence to the strictest quality standards. The QUMAS quality initiative begins with an enterprise-wide quality framework designed to align our software development and service delivery to ensure quality results. Our approach to software quality removes quality assurance testing from the end of the software development life-cycle and integrates an iterative test process throughout the software development life-cycle (SDLC).
At QUMAS, we use our own software product, DocCompliance, to manage the day-to-day running of our quality management system. Our quality management practices incorporate a comprehensive set of Standard Operating Procedures (SOPs), guidance documents, and traceability matrices to ensure quality.
We strongly recommend and support the supplier audit process by offering on-site inspections upon request. We have been audited by independent organizations such as the Parenteral Drug Association (PDA) and many of our leading clients, including; Merck, Roche, C.R. Bard, and others. 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.