QUMAS - Regulatory Compliance Solutions for the Pharmaceutical, Biotechnology and Medical Device Industries White Papers

ProcessCompliance Datasheet QUMAS ProcessCompliance™ enables organizations to standardize and automate their business processes that manage the collection, tracking, and analysis of information and the resolution of related issues. ProcessCompliance includes web-based, configurable processes, workflows and forms that can be tailored to meet the needs of the organization. ProcessCompliance integrates with QUMAS DocComplianceTM to provide access to controlled documentation during all phases of process management and with QUMAS ComplianceUnityTM for sophisticated reporting of their business performance. Organizations not only benefit from an increase in efficiency and accuracy of business processes and activities, but also proactively improve their business performance.
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DocCompliance Datasheet QUMAS DocComplianceTM is the cornerstone of the QUMAS Compliance PlatformTM. As an off-the-shelf web-based regulatory content management system, DocCompliance ensures enterprise-wide consistency and compliance. The solution enables organizations to create, manage, and securely store documents, using built in password policies to protect against unauthorized access. It contains full support for Electronic Signatures as per FDA 21 CFR Part 11 requirements. Best practice document management workflows ensure that the correct content is created, reviewed, approved, consumed, distributed and retired. It encourages optimum content management through built in best practices. Flexible configuration enables you to easily mirror your existing organizational structures and practices, and the intuitive user-interface ensures ease-of-use for all end users. DocCompliance can be used in conjunction with MyQUMASTM, which provides access to the full capabilities of the QUMAS Compliance platform including flexible business process management, learning management, business intelligence and content collaboration.
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MyQUMAS 2011 MyQUMAS is a user friendly solution that provides access to all QUMAS Compliance Platform capabilities in one view. It allows people to easily connect and collaborate on compliance content, processes, tasks, training and reporting from one central location.
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Total Cost of Ownership Truths to Consider When Deploying an Enterprise Compliance Management System Life sciences companies, as one of the most heavily regulated industries, are faced with the need to accurately manage, track, and trend a vast number of quality (GxP) and regulatory compliance issues.
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Sound Document Management Lays the Groundwork for Life Sciences Regulatory Publishing When publishing a dossier, life sciences companies typically struggle with efficiently compiling supporting documentation. Usually, this is the result of dealing with paper and electronic documents, legacy versions and incomplete or inaccurate data due to human error. This does not need to be the case. To prevent documentation from becoming a costly issue, companies can take steps (on the front end and throughout the entire document lifecycle) to enable a smooth submission process.
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Streamlining and Accelerating Change Control In today’s highly regulated life sciences environment, organizations face a myriad of regulations and regulators, affecting all aspects of the enterprise. One area coming under increased regulatory scrutiny is change control: the ability to manage deviations to established policies and procedures in a way that is efficient, timely and compliant.
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