Pharmaceutical and Biotechnology Industries
Bringing new products to market faster represents an enormous pressure for pharmaceutical and biotechnology companies in today’s rapid pace market. These companies are continually searching for more efficient ways to deal with the integrated challenges of product development, regulatory compliance, and governance that impact their business operations.
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.
Due to several market and regulatory factors, most companies will have to develop strategies and systems to accomplish more efficient compliance management throughout the enterprise in order to maintain profitability and market share while reducing risk. Technology innovation and a merging of governance, risk, and compliance (GRC) regulatory philosophies now allow companies to achieve business improvement through the integration of all their GRC requirements throughout the enterprise.
Leading pharmaceutical and biotechnology companies across the globe deploy Amadeus solutions to drive increased productivity and efficiency to meet global regulatory requirements within an integrated solution. These companies are faced with GxP requirements, 21 CFR Parts 11, 210 and 211, ISO standards, and Sarbanes-Oxley requirements to name only a few. Pharma and biotech companies using the Amadeus software solution, eQCM, are building quality and compliance into their business processes to manage variability and eliminate regulatory risks before they start.
- Enables organizations to comply with ISO 9000 and 14001, FDA, EPA, Sarbanes-Oxley, 21 CFR Parts 11, 210 and 211, GxP, and other industry standards.
- Shares information between processes enabling the flow of information to be seamless and delivering a more realistic process approach.
- Allows organizations to be and stay in control of their compliance processes with the Process-In-Control capabilities which allow managers to pinpoint problematic areas and implement and track solutions.
- Ensures the integrity of electronic records and signature as required in 21 CFR Part 11.
- Fosters collaboration and allows manager to visualize and monitor all quality and compliance processes as a unified system by connecting departments and personnel with appropriate data and processes.
- Delivers a risk-based approach in to managing nonconformance, deviations and change.
- Allows companies to easily update the organizational model within the system and the changes are propagated through your business processes, hence, giving the users the agility to change processes as the organization and regulations change.
- Ensures process continuity through the integration with MS Outlook, delivering notifications, alerts, specified process information and access to the specific task within the e-mails.
- Provides advanced reporting and dashboards for all critical business processes and delivers timely information that you can act upon to ensure sustainable compliance and improve compliance business performance.
Amadeus automates pharma and biotech processes to improve efficiency.
Here are a few processes:
- Internal/external assessments
- Nonconformance management
- Customer complaints
- Document management and SOP enforcement
- Employee qualification and certification
- Supplier quality
- Equipment management
- Procurement Process
- Change control
