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Omnify for High Tech/Electronics Manufacturers

Today's fast pace of technology development, growing customer demands, complex products, and compliance mandates make it more and more difficult for Electronics manufacturers, Contract Manufacturers (CMs) and Electronic Manufacturing Services (EMS) companies to meet product goals on time and under budget.
Streamline the flow of information among your Engineering, Documentation Control, Quality/Test, Manufacturing, Management and Outsourcing Partners. Omnify Software helps High Tech Electronics manufacturers by providing a single environment for creating and changing product information, processing new part requests and Engineering Change/ECO notifications, conducting preliminary Bill of Material (BOM) reviews, managing AVLs/AMLs, executing Corrective and Preventive Actions (CAPAs), and more.

Key Benefits of Empower PLM for High Tech/Electronics Manufacturers

Reduction in the time it takes to create and release engineering changes
Elimination of scrap due to incorrect builds
Elimination of lost schedule time due to supply or BOM issues
Streamlined communication between OEM and manufacturing partners
Ensure adherence with environmental compliance requirements (RoHS, REACH, Conflict Minerals)
Improved product quality
Decrease operational costs

Omnify for Medical Device Manufacturers

Medical Device Manufacturers are faced with the exceptional challenge of delivering innovative, safe and compliant products to the market. Performing product design and development tasks in a manual fashion can cost time, money and possibly a failed audit.
Numerous medical device customers are using the Empower PLM solution to manage their product data in a controlled environment with automated Bill of Material (BOM), Product Documentation and Engineering Change Management to improve efficiencies and ensure data accuracy. Medical Device manufacturers also benefit from our Quality Management and Training Records Management capabilities to manage CAPAs, complaints and training records and tie this information directly to the product record. This also helps our customers eliminate the need to purchase separate Quality Management and Training Management systems.

Simplify Your ISO and FDA Audits

Omnify can help your organization meet your compliance requirements such as: 21 CFR Part 11, 21 CFR Part 820, ISO 13485, etc.

Design Controls

Design controls are not only a regulatory requirement, they lay the foundation for the proper design and development of medical devices and can provide device manufacturers with the opportunity to address and/or correct problems early in the design process. Omnify Software can help ensure compliant design controls, address design control challenges, simplify your audit process, and reduce the cost of compliance for your organization by supporting effective and efficient product development procedures.

Supplier Management

Manage Approved Vendor Lists (AVLS)/Approved Manufacturer Lists (AMLs), eliminate inventory issues, management reports and dashboards, up to date supplier data across the enterprise.

Corrective Actions/Preventive Actions (CAPA)

Our Quality Management module offers a closed-loop Corrective and Preventive Action (CAPA) system that captures and routes (for resolution) any product defects and issues. The Quality Management module is integrated with all product data stored in Omnify Empower, offering a unified location to manage both product and quality data.

Traceability

Critical for meeting compliance, the Empower PLM system provides full traceability on all actions made within the system for an electronic audit trail.

Validation

One of the benefits of the Empower PLM system is the option to choose a deployment strategy that best works with your validation requirements (on-premises or hosted). Our medical device customers have successfully validated their Empower PLM systems to meet compliance guidelines.

Reporting

Omnify Empower PLM provides the necessary reporting and analysis tools for medical device manufacturers including: custom reports, Device Master Record (DMR) reports, Design History File (DHF) reports, Device History Record (DHR) reports, and customizable dashboards.

Key Benefits of Empower PLM for Medical Device Manufacturers

Controlled environment to manage all of your product data (bill of materials, document control, change control, project management, CAPA/quality management, and training)
Password-protected signoffs and authorized signatures to manage user authentication and authorization
Complete history tracking for electronic audit trails
Easy reporting and analysis (custom reports, DMR/DHR/DHF reports, customizable dashboards)
Defined user roles to control accessibility
Compliance with Quality System regulations through our Closed-loop Corrective and Preventive Action (CAPA) system and Training Records management
Automate and unify processes across all product-related areas and eliminate need to purchase separate quality and training systems
Experience helping large and small Medical Device Manufacturers adopt compliant processes

Omnify for the Automotive Industry

It's all about speed. For automotive parts suppliers and OEMs, keeping up with fast development cycles is critical to meeting product targets and maintaining a competitive advantage. Constantly changing parts require efficient Engineering Change and Product Documentation processes.
Automotive parts suppliers and OEMs are using Omnify Empower PLM to manage Engineering Changes, Bill of Materials (BOMs) and product documentation to improve change and part control processes, ensure data accuracy across the enterprise and enhance product quality.

Key Benefits of Empower PLM for Automotive Manufacturers

Reduction in the time it takes to create and release engineering changes
Streamlined communication among internal and external teams
Full history trail on all changes
Reduction in costly rework
Adhere to quality system compliance guidelines
Improved product quality

Omnify for Aerospace and Defense Manufacturers

Aerospace and Defense manufacturers are often faced with complex configuration and document management challenges associated with managing this information via manual or paper-based processes. A system that delivers revision management for full traceability on all product configurations, streamlines communication with manufacturing partners and ties quality information to the product record is critical to not only address these issues but to adhere to certain standards such as the US aerospace and defense AS9100 quality management standard, ISO 9001:2008, ITAR, and FAA regulations.
Aerospace and Defense manufacturers are using the Empower PLM solution to automate configuration and document management processes in order to increase product revenue, decrease product cost, and reduce product development cycles.

Key Benefits of Empower PLM for Aerospace and Defense Manufacturers

Easily manage revisions and variances for Bill of Materials (BOMs) and documents
Automatically track changes to parts and assemblies (who, what, when, & why)
Securely communicate product and change information with manufacturing partners and colleagues
Improve part selection with the ability to share cost and lead-time information about components with engineering
Adhere to quality system compliance guidelines