Cetec ERP released versions 4.19 and 4.20 designed with new capabilities to support the day-to-day compliance and quality needs of medical device and life science companies. The updates deliver greater control over regulated processes, quality tracking, and supplier oversight — all within a single integrated ERP system.

One of the new features is a customizable Device History Record (DHR) document that is automatically generated and tied to the order, work order, and invoice. This consolidated record captures the complete manufacturing history for each device, making it easier for manufacturers to prepare for audits and meet documentation expectations under FDA Quality System Regulation and ISO 13485.

A new “Require Validation” option in workflow stages prompts password reentry before an object can advance. For companies operating in regulated environments, this adds an important safeguard for electronic authorizations and supports secure sign-off requirements often associated with FDA 21 CFR Part 11.

The Corrective Action Report (CAR) module now supports user-defined fields, allowing quality teams to capture additional details during investigations and follow-up. This added flexibility strengthens Corrective and Preventive Action (CAPA) programs by making it easier to track, analyze, and retain the information that matters most for compliance and quality improvement.

New home page dashboard widgets give real-time visibility into inspection results. A pie chart displays inspection failure codes while an “Inspected vs. Rejected” widget shows quantity metrics, yield percentages, and PPM. These tools help quality managers identify trends and address issues before they escalate.

•    Vendor Performance with Custom Metrics – Expanded tracking options for supplier performance, supporting more comprehensive supplier quality management programs.

•    Work Instructions on Order Splits – When orders are split, completed work instructions now carry over to the new line, preserving the continuity of production records for audit purposes.

“For manufacturers in regulated industries, compliance and quality are constant priorities,” said Taylor Wagen, COO at Cetec ERP. “These updates are about giving teams more control and clarity over their processes, so compliance isn’t a separate burden — it’s simply part of how they run their business in Cetec ERP.”

Cetec ERP
www.cetecerp.com