QUMAS Introduces First Closed-Loop Compliance Solution for Life Sciences Industry
FLORHAM PARK, NJ — (MARKET WIRE) — November 07, 2006 — QUMAS, a leading provider of quality management and regulatory affairs solutions, today announced the life sciences industry’s only end-to-end closed-loop compliance solution. The QUMAS Compliance Closed-Loop Process™ automates the tracking and management of compliance, business or quality issues enterprise-wide, integrating them with other processes critical to regulatory compliance such as change control, audit, and customer complaints. Rather than treating compliance as a series of silos that vary with department and/or stage in the product lifecycle, life sciences companies, for the first time, can treat compliance as a single process. The result is a sustainable, repeatable and cost-effective compliance system that assures consistent quality output across the organization.
“Effective closed-loop systems are becoming critical to the success of life science companies,” said Chris Connor, senior research analyst at Health Industry Insights, an IDC company. “The ability to conduct adaptive trials or develop a scalable safety system depends on the availability of high quality data from multiple systems. However, without the capability to insure process integrity and unambiguously demonstrate regulatory compliance, the true benefits of a closed-loop system are lost. Today, life science companies are faced with the challenge of deploying automated solutions that can track and manage their company’s compliance obligations. Products such as the QUMAS Compliance Closed-Loop Process provide a framework for life science companies to deliver a complete and sustainable compliance solution that can span the entire enterprise.”
Closed-Loop Process automates content and process management
QUMAS now makes it possible for life sciences companies to automate compliance-related business processes across the enterprise and monitor internal processes, procedures and workflows from one centralized location. The QUMAS Compliance Closed-Loop Process comprises the following critical steps to ensure ongoing compliance with a wide range of regulations and initiatives, all of which are performed in a pre-designed complaint manner:
-- Track and interpret regulations -- Document policies and procedures -- Monitor conformance with policies and procedures -- Communicate, train and educate -- Capture planned and unplanned exceptions and deviations -- Audit and investigate -- Manage exceptions and deviations end to end (including impacts onto other enterprise applications e.g., ERP or processes) -- Measure, assess and implement change
The QUMAS approach automates the generation of internal or external complaints, product non-conformances, deviations, audits, investigations and all other actions. From initiation to closure, QUMAS captures, records, routes and verifies completion and approvals while auditing each step in the quality management process. By using a single, integrated solution to address compliance and quality management, life sciences organizations realize the following benefits:
-- Reduced validation costs -- Reduced operational and training costs -- Avoidance of costly duplication of resources and compliance technologies -- Assurance of a consistent and standardized approach to compliance implementation across the enterprise -- Ability to respond quickly to new regulations and constantly evolving legislative demands without having to rethink an entire approach to compliance management -- Assurance of consistent quality output across manufacturing facilities -- Focus on product safety and the introduction of high quality products -- Enterprise-wide reporting and monitoring capabilities -- Facilitation of regulatory audits
Robust auditing and reporting capabilities
“QUMAS enables us to comply with FDA regulations more efficiently,” said Steve Heilman, system administrator at Regeneron. “The FDA requires companies to quickly address deviations in the drug manufacturing process and to close them out as soon as possible. QUMAS automatically tracks deviations and sends a report to the appropriate person for corrective action. It makes the entire process much more proactive and allows us to identify and fix problems before they can turn into bigger issues and drain resources.”
QUMAS ProcessCompliance a key component
One of the powerful technology engines behind the closed-loop process is the recently released QUMAS ProcessCompliance.™ Other products include the QUMAS flagship offering, DocCompliance, as well as the QUMAS CompliancePortal.™ Entirely Web-based, QUMAS ProcessCompliance delivers pre-configured, built-in best practices for the management of a wide range of processes, including change control, corrective/preventive actions (CAPAs), planned and unplanned deviations, audits, validation, customer complaints, multi-site change control and enterprise system change control. QUMAS ProcessCompliance can also push any identified compliance issues to the appropriate individual or department for corrective action. In addition, it automatically creates a fully complaint audit trail and allows simplified reporting for all data managed in the system.
QUMAS ProcessCompliance eliminates disparate silos of information that can be created due to various stand-alone compliance solutions that address only one regulation. By automating compliance processes, companies can consistently enforce standards across multiple locations.
Fully configurable and scalable, QUMAS ProcessCompliance also provides alerts in the event that deviations from best practices occur and features:
-- Comprehensive issue tracking in a fully closed-loop system that drives issue resolution -- Extensive reporting capabilities through integration with Crystal Reports -- Seamless integration with all controlled documentation in QUMAS DocCompliance -- Secure Audit Trail, ensuring a constant state of 'audit-readiness' -- Built-in electronic signatures and compliance with predicated rule requirements for effective electronic records management -- Flexibility by adapting to existing structures and ensuring best practices are standardized enterprise-wide by means of configuration (rather than customization)
“With our closed-loop process, we are able to provide quality, manufacturing and regulatory affairs executives with information and reports in a format that is easily understandable by senior management,” said Ken Hayward, head of the QUMAS life sciences division. “Companies are able to make more informed strategic decisions quickly without having to wait for compliance teams to distill large amounts of information from across the enterprise into concise and relevant data points.”
About QUMAS Compliance Suite
The QUMAS Compliance Suite enables life science companies to effectively manage the creation, review, approval and revision of the content; efficiently interact with submission management systems; and ease the process for handling Process Change Control, Adverse Events and other data-centric requirements. The QUMAS Web-based application suite enables organizations to consolidate and manage their regulatory compliance requirements through a configurable enterprise software suite. Accessed through the CompliancePortal™, which provides a role-based point of access, the Compliance Suite includes two complete software applications — DocCompliance™ and ProcessCompliance™.
About QUMAS
QUMAS is a leading developer of enterprise compliance management solutions designed to help life sciences organizations meet industry and government standards for 21 CFR Part 11, cGxP, Quality, Regulatory Affairs and Clinical Operations. With over a decade of experience, QUMAS is helping companies accelerate business processes, reduce costs and improve quality. From content lifecycle management, business process and change management to reporting and analysis, QUMAS’ Compliance Suite is successfully enabling global life science organizations to proactively manage their regulated content and processes in a secure and compliant way.
For more information visit http://www.qumas.com.
