Orthoplastics: Meeting US and European regulatory requirements

Introduction

Orthoplastics is a UK-based manufacturer specializing in medical-grade UHMW-PE material for the orthopedic implant market. As the industry faced growing regulatory demands, Orthoplastics needed a solution that could help manage and streamline their Quality and Environmental Management Systems (QEMS) while ensuring compliance with stringent US and European regulations.

The challenge

Before implementing Ideagen, Orthoplastics faced several critical challenges:

• Fragmented document management hindered efficiency and increased the risk of errors. 
• Compliance with multiple regulatory standards, including ISO and FDA, was difficult to manage. 
• Limited visibility into corrective and preventive actions (CAPAs) and audit processes reduced control over compliance activities.

Finding the right solution

Orthoplastics selected Ideagen for its ability to: 

• Centralize document management, making all QEMS documents easily accessible and reducing manual processes. 
• Integrate auditing and CAPA activities, providing greater visibility and control over compliance tasks. 
• Ensure role-based access to sensitive information, enhancing security and compliance with regulatory standards.

Implementation and impact

The adoption of Ideagen at Orthoplastics marked a significant shift from fragmented and labor-intensive processes to a streamlined, centralized system that enhanced compliance and efficiency.

The ability to manage all aspects of their Quality and Environmental Management Systems in one place not only improved operational performance but also ensured that Orthoplastics could meet the stringent demands of regulators and customers alike.

Overall, the implementation at Orthoplastics resulted in:

• Centralized document management, improving accessibility and reducing manual processes. 
• Enhanced compliance activities, with integrated auditing and CAPA functions providing greater visibility and control.
•  Improved security, with role-based access ensuring only relevant documents are accessible to appropriate staff.