Our commitment to quality is unparalleled in the compliance industry, and we are one of the few vendors in our market who are I.S EN ISO 9001:2000 certified (certificate number 5005). 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: 2000 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.










