Cetec ERP Streamlines Medical Device Manufacturing Quality Processes for Reliable Compliance Outcomes

Medical device manufacturing continues to evolve in ways that improve processes and support health outcomes in new ways. The fast-moving industry requires the maintenance of stringent quality control processes to ensure safe outcomes for users. To that end, companies face the challenge of achieving pre-determined specifications within their quality system and process controls to meet FDA inspection requirements.

Traditionally, the meticulous recording and organization of production and process controls was done through cumbersome paper files. However, with the advent of modern enterprise resource planning (ERP) systems, companies like Cetec are revolutionizing the way medical device manufacturers manage their quality processes.

Cetec ERP can help medical device companies in several ways:

Work instructions made easy

Work instructions play a crucial role in verifying that the manufacturing process aligns with quality requirements. In the past, these instructions had to be recorded and stored in physical files. Cetec ERP has transformed this cumbersome method by providing a digitized labor plan. This allows companies to manage and document work instructions in one reliable digital hub, ensuring compliance and easy accessibility.

Controlled equipment and instruments

The maintenance of equipment, tools, and instruments involves intricate checks, inspections, and validations. Cetec ERP simplifies this by offering an organized system where this information is defined and linked to the bill of materials (BOM) revision. With a check-in/check-out history on work orders, companies can easily track the usage of equipment, tools, and instruments, ensuring a streamlined and controlled process.

Device history record (DHR) accuracy

Work orders serve as a comprehensive source of information for the device history record (DHR). Cetec ERP captures every movement within a work order, from location changes to logged labor, with an electronic signature. This ensures that every lot and serial is meticulously documented, including raw data required for the DHR. This data is stored and easily accessible, facilitating audits, recalls, or any other necessary reference points.

In-process inspections and NCRs

Cetec ERP’s in-process inspections can be customized for unique tolerances and yields. When a failure occurs, it triggers an immediate non-conformance report (NCR) during the work order process. The ERP system pulls detailed information from the work order and generates accurate reports on these details. NCRs are then escalated and grouped into corrective action and preventive action (CAPA), creating a complete quality management system (QMS) with a seamless link back to the source inspection.

Efficient revision changes and controls

Engineering change orders (ECO) are seamlessly integrated into Cetec ERP. These orders facilitate revision changes through an approval and sign-off process, allowing collaboration across multiple departments. Active work orders can be ‘frozen’ until the ECO is completed, preventing any updates or movements during this time. This meticulous control guarantees that all data and documentation are updated in the system, providing a comprehensive audit trail and history for revision changes, which is critical for meeting compliance requirements.

Cetec ERP offers an effective digital transformation and repository of medical device manufacturing quality control processes. By integrating work instructions, equipment management, DHR accuracy, in-process inspections, and revision controls, Cetec ERP enhances compliance and saves valuable time and resources. In an industry where precision is paramount, embracing such advanced ERP systems is not just a choice but a necessity for sustained success in medical device manufacturing.

Learn more about the Cetec ERP system and how it can streamline your medical device manufacturing production control, supply chain, and traceability.