QUMAS

  • Website: http://www.qumas.com/
  • Size: 51-200 employees
  • Overview: QUMAS is the leader in Quality and Compliance Management Solutions for the Life Sciences sector with more than 270 global customer deployments and 20 years experience in regulatory compliance. QUMAS Solutions provide document, quality and incident management software that ensures compliance with global regulations. The QUMAS Compliance Platform is the only platform that provides access to all compliance initiatives across controlled content and processes through one user interface, reducing the number of point solutions needed to address regulatory mandates. The Platform also combines document migration, regulatory submissions, training and collaboration capabilities in one central location, simplifying task management and regulatory reporting. QUMAS solutions for Document & Quality Management provide Electronic Document Management (SOPs, QA documents), Process Management (CAPA, Deviation, Change Control, Audit), and GMP Compliance Management. QUMAS Regulatory Affairs solutions also provide Submission Management including eCTD authoring templates, scanning and automated importing of paper documents and the migration of documents from legacy systems, as well as collaborative review and full integration with leading publishing solutions. All QUMAS solutions include built-in electronic signatures, audit trail (FDA 21 CFR Part 11), role-based permissions and controlled access to all content and processes and are available on SharePoint 2010, Documentum, Oracle & SQL Server.

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