Medical Device Industry
In today's highly competitive marketplace, more stringent quality control and higher product reliability requirements have become vital for the medical device industry. Strict FDA regulations such as 21 CFR Parts 820 and 11, GMP, ISO standards such as 13485 and 9000, shorter product lifecycles, failures cited in warning letters, product delays, and periodic audits are among the challenges these companies are facing in order to stay in business. The medical device public companies are also facing the requirements stemming from the Sarbanes-Oxley Act.
Amadeus offers peace of mind for the medical device industry with its solution for enterprise quality and compliance management (eQCM). The secret to successfully meeting these challenges lies in implementing a quality and compliance management system that will help with the control and automation of processes. Through Amadeus’ unique process workflow engine, medical device organizations can build and manage effective controlled processes for each stage of the design process to ensure that all relevant design documentation and process information is easily captured, managed, routed to the appropriate individuals and up-to-date in accordance with current regulations. The fully web-based solution enables medical device companies to take an integrated, risk-based approach to ensure product safety through compliance processes responding to industry best practices, regulatory requirements, and internal mandates (SOPs). eQCM’s Processes-In-Control windows provide powerful performance metrics, warning indicators, and unrivaled search capabilities that allow a company to stay in control of its compliance and quality processes.
Amadeus’ 21 CFR Part 11 compliant solutions help medical device companies:
- Take a risk-based approach to managing nonconformances, deviations and change management
- Reduce the cost of compliance, while fully meeting FDA requirements
- Provide the top-down enforcement of SOPs, Quality System Regulations (QSR) and ISO 13485/14971 requirements and best practices
- Improve profitability by reducing variability, eliminating waste, adhering to schedules and commitments and reducing cycle times
- Enables organizations to comply with 21 CFR parts 11 & 820, GMP, ISO 13485, ISO 9000, Sarbanes-Oxley, and other industry standards to name only a few.
- Reduces the cost of compliance by the integration of information between processes enabling the flow of information to be seamless and delivering a more realistic process approach.
- Allows organizations to easily update and change their processes as the organization and regulations change. Empowering users to create and perform changes to a process without the intervention of IT or Amadeus team.
- Delivers a risk-based approach to managing nonconformances, deviations and changement management.
- Provides advanced reporting and dashboards for all critical business processes delivering timely information that you can act upon to ensure sustainable compliance.
- Ensures sustainable compliance and improvement over product safety requirements by enhancing visibility to critical quality data and process cycle times.
- 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 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 efficient workflow management by allowing integrated process workflows. For example, an organization can create a product nonconformance process to automatically start a particular corrective action workflow based on severity or other items. Parent and their related children workflows can be monitored. The workflow integration enables the flow of information to be seamless and delivers a more realistic process approach.
Amadeus automates medical device processes to improve efficiency and speed time to market. Here are a few processes:
- Document management
- Change control
- Nonconformance management
- Corrective and preventive actions
- Complaint Management
- External and Internal Audit
- Out of Spec and Deviation handling
- Procurement processes
- Calibration
- External regulatory library
- Competency management
- SOX compliance
