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Union designed to improve operational efficiency, audit response times and maintain GxP, GCP and GMP compliance.
October 15, 2018
By: Business Wire
SOLABS, a software developer of the QM 10 EQMS solution, designed and optimized for Life Sciences companies, and Questionmark, global provider of assessment technologies, are partnering to provide SOLABS’ life sciences clients with new testing and assessment features that will enhance the journey to training compliance. “Questionmark is excited to partner with the SOLABS team to provide meaningful and trustworthy results where and when they really matter,” said Eric Shepherd, CEO of Questionmark. “Partnering and integrating with the SOLABS Enterprise Quality Management System helps our customers improve their operational efficiency, audit response times and maintain GxP, GCP and GMP compliance by automating quality operations with respect to FDA 21 CFR Part 11 and Annex 11.” SOLABS’ Life Sciences partners and clientele are faced with stringent regulatory scrutiny regarding the level of formality and type of training required by its employees. This new collaboration with Questionmark will greatly enhance the SOLABS QM 10 product and provide SOLABS clients with the opportunity to utilize the Questionmark assessment functionality to add further robustness to their internal training programs with the ease of a seamlessly integrated platform. The Questionmark training module will ensure valid and reliable assessments that provide defensible and trustworthy results. “At SOLABS, we truly are passionate about quality automation,” said Philippe Gaudreau, CEO of SOLABS. “This partnership with Questionmark will allow us to further improve quality levels for our clients by allowing them to gradually replace the current ‘read and understand’ practices with formal assessment of competencies. Assessment technologies are in a world of their own and we have chosen to partner with a best of breed vendor who offers a Cloud option. Questionmark is not new to SOLABS, we have had great success with building client specific interfaces with our previous generation platform and today we are extremely happy to offer this value-added option to all of our clients running QM10! It comes as a natural extension of QM10 and is fully transparent for the end-users.” SOLABS is dedicated to serving the needs of companies in the life sciences industry with SOLABS QM, its integrated Enterprise Quality Management System (EQMS) software that helps companies improve their operational efficiency and maintain GxP compliance by automating their quality operations with respect to FDA 21 CFR Part 11 and Annex 11. Its software allows companies to manage CAPA, complaints, controlled documents, change control, and audits, as well as employee training in a single user interface. SOLABS understands the specific challenges faced by each sector of this industry, including medical device, pharmaceutical ,anufacturing, biotech, clinical trials, and R&D. Questionmark assessment technologies are used by organizations worldwide to securely measure knowledge, skills and attitudes for certification, regulatory compliance, workforce learning, channel expertise and higher education. Questionmark’s assessment management system provides collaborative, secure authoring of questions and assessments; comprehensive item banking; multiple delivery options including mobile devices; powerful reporting and analytics to inform stakeholders; and trustworthy, defensible results. Questionmark is committed to the Health Insurance Portability and Accountability Act (HIPAA) which sets the standard for dealing with protected health information and ensures physical, network, process security measures and the appropriate business associate agreements are in place.
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