Quality and Compliance Management Solutions
for the Life Sciences Industry

Life sciences

Life sciences companies face many unique challenges.  In an age of enhanced consumer awareness and FDA initiatives surrounding pharmaceutical quality, it is critical that companies focus on product quality throughout the product lifecycle to reduce operational and reputational impacts and costly product recalls.  In addition, regulatory, revenue, channel and competitive pressures make it increasingly more important for these companies to foster quality resources for profitable growth.

In August, 2002, the U.S. Food and Drug Administration (FDA) launched the first major overhaul of pharmaceutical current Good Manufacturing Practices (cGMPs) in a quarter-century. The new directive, entitled “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach”, outlined the agency’s vision for a new approach to manufacturing and compliance based on risk analysis, improved process understanding and quality system methodologies.  It encourages modern approaches to manufacturing, monitoring, and control to enhance process predictability and efficiency. Although the introduction of another key initiative, Process Analytical Technology (PAT), takes a different approach to quality assurance (process controls and in-process data versus single laboratory determinations to make batch acceptability decisions), the focus of the FDA initiatives continue to remain on enhancing product quality.

Life sciences firms are bound by regulatory requirements such as Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs), as well as 21 CFR Part 11 from the FDA and the Sarbanes-Oxley Act of 2002.   In addition, life science companies are subject to various health & safety and environmental regulations.   Over the last several decades, companies managed their quality, health & safety, and environmental, financial and other compliance requirements through traditional hardcopy means or via a collection of disparate systems (point solutions).   Even with the deployment of globalized ERP solutions, the specific compliance areas are still often managed in silos, divided along organizational or domain lines.  In addition, the management of risk and corporate governance within organizations have often been managed separately from the traditional compliance areas.  Without a comprehensive , integrated, and strategic approach to quality and compliance, financial impacts can be compounded due to inefficient processes, lack of collaboration, and incomplete compliance indicators.

Amadeus offers a software solution, eQCM^®, for successfully meeting these requirements while lowering the associated compliance? costs that can otherwise be substantial. Achieving sustained compliance with current regulations means that companies must have the agility within their compliance systems infrastructure to change processes as their organizations and regulations change.   This means that eQCM can help companies manage product quality through the product lifecycle and value chain, ensure resource quality through the management of competencies and training, and use a flexible process approach to communicate and perform the most critical activities in the organization at the right time. 

Amadeus automates life sciences processes to improve efficiency. Here are a few processes:

• Deviations
• Out-of-Spec, Exceptions/investigation Tracking
• Incident Management
• Customer complaints
• Internal and External Audits
• Supplier Audits
• Corrective and Preventive Actions
• SOP policies and procedures
• Document Management & Changes
• Change Control/Change Management
• Training and Learning Management
• Internal control management
• IT governance