Life & Health Sciences

The Life and Health Sciences industry is constantly striving to launch new products in the market while meeting stringent compliance requirements of the US FDA, Joint Commission, Good Clinical Practices, HIPAA, and ISO. Intense competition in the industry calls for better measures to meet these demands. Life and Health Science companies must address a broad range of regulatory issues in addition to governance, risk, and compliance. However, regulatory compliance forms the core of any Life Science company or Healthcare Center and it ensures a competitive supply chain, higher customer confidence, and reduction in negative inspection outcomes. Since these industries are constantly being challenged to comply with rigorous standards, it is critical to use a robust Quality Management System that evolves with the needs of the industry and integrates with the existing manual processes.

Proquis solutions are designed to enable the Life Science organizations and Healthcare Centers to take an integrated approach towards compliance and quality management through a web-based and modular system.

Some modules of the Proquis Solution vital to Life and Health Science industries are:

• Document Control: Ensures that the policies, procedures, processes, and work instructions are documented, controlled, and available to users.
• Issues and Actions / CAPA: Ensures the recording and managing of non-conformances and their corrections (short-term and long-term).
• Audit: Allows demonstration that the organization is reviewing its effectiveness and compliance with all applicable regulations.
• Personnel and Training: Ensures that relevant staff is qualified to complete the tasks covered by the applicable regulations.
• Effective Reporting: Allows special customized analysis/summary reports to be run for Management review and monitoring that can save the company considerable time every month.
• Process Improvement: Ensures all critical processes are mapped, analyzed, and recorded for continuous improvement and enhanced business performance.

If you need an integrated solution that is modular and can be expanded as your needs grow, please contact us to see how our Proquis solutions can take your company to the next level.

Additional Resources:

Case Study: Smith & Nephew boosts BIRMINGHAM HIP Resurfacing

Case Study: Is your Document Control out of Control?