Regulatory oversight of the medical device industry is growing as the FDA and global regulators work to improve patient safety by minimizing the risk of device-related injuries and adverse events. The industry as a whole is shifting from a reactive to proactive approach across all aspects of medical device operations – from research and development (R&D) all the way through to distribution. Medical device manufacturers are being required to submit more data on their processes and products than ever before, and in many cases, do so in an electronic manner.
Medical device manufacturers are relying more heavily on regulatory affairs (RA) and RA professionals’ roles are expanding. With regulators scrutinizing everything from the environmental impact of device design to imported components, RA professionals must have global visibility and access to accurate, reliable and timely data to remain compliant and reduce risk for their organizations.
How Sparta Systems Can Help:
Sparta Systems enterprise quality management software (EQMS) for regulatory affairs provides a centralized workflow management solution to manage and track global product portfolios, providing both worldwide and local views into product information. Sparta Systems software delivers an efficient, cost-effective, global solution for capturing and tracking all required regulatory submission information, commitments, and tasks pertaining to new products and product lifecycle management.
Benefits of Sparta Systems’ Regulatory Affairs Solution:
- Improves accuracy of registration information
- Tracks and manages all phases of the regulatory process, product lifecycle and submission process
- Facilitates global compliance by reporting on registration status by country, product type, indication, dosage or any other classification
- Integrates with document and change management, SOP tracking and regulatory auditing
- Manages and tracks correspondences with health authorities as well as resulting commitments and tasks
- Manages and tracks regulatory notifications or approvals as a result of change controls initiated by other parts of the organization
- Manages and tracks regulatory reporting processes including product safety update reports (PSURs), with links to original submissions