Medical Device Directory

Omnify Empower PLM

Available from Omnify Software

Omnify Software provides business-ready Product Lifecycle Management (PLM) solutions that help medical device and equipment manufacturers deliver innovative, safe and compliant products while eliminating costly redesign and shortening development cycles.

The Omnify Empower PLM solution provides a central, controlled environment to manage all product data, Bill of Materials (BOMs), documents, and vendor/supplier information. Leveraging the systems’ inherent engineering change/design control, Quality/CAPA, and Training Record Management capabilities ensure adherence to enterprise-wide compliant product development processes.

Omnify Software helps manufacturers meet and exceed formal audits, including FDA (21 CFR Part 11 and Part 820) and ISO, with out-of-the-box features such as:
-Automatic audit trails for any change/modification
-Dual password options for login and signoff
-Complete closed-loop Corrective and Preventive Action (CAPA) system
-Training records management
-Supplier management
-Device Master Record/Device History Record/Design History File reporting

The ease of use, fast implementation and cost-effective price of the Omnify Empower PLM solution make it ideal for small to mid-tier medical manufacturers yet it is scalable to meet the needs of larger enterprises.

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