Change Management Software

Change Management within the Enterprise Quality Management System (QMS) refers to the structured approach of transitioning individuals, teams, and organizations from a current state to a desired future state. It is a critical aspect of QMS because it ensures that changes to processes, products, or systems are implemented in a controlled and systematic manner, thereby maintaining the integrity of the quality management process. This approach minimizes risks and maximizes the benefits of change, ensuring continuous improvement and compliance with regulatory requirements. Several standards emphasize the importance of managing change as part of ensuring quality, safety, environmental management, and information security.

Change Management Software is compliant with the following standards:

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
ISO 27001:2013
ISO 13485:2016
ASPICE

Omnex Systems has successfully completed the SOC 2 Certification, reinforcing our commitment to maintaining the highest standards of data security and privacy for our clients.

View All certifications

Request Demo

Webinars

Strategy and Evolution of Enterprise Quality and Integrated Management Systems Software

Watch Webinar

Challenges of Implementing APQP

Watch Webinar

Whitepapers

Digitalization of New Product Development

Enterprise Digitalization of APQP 3rd Edition & Control Plans V.1

Case Studies

Shift-Left – Integrating Product Risks in New Product Development Using FMEA

Digital Transformation of Enterprise Quality Management Solution for a Leading Tier-1 Automotive Supplier

Features and Benefits (Change Management Software)

Change Management

Manage critical changes across the product lifecycle with a seamless, structured change management process that eliminates disconnects and ensures full traceability.

Automated Workflows

Automate the approval, implementation, and review processes for changes, helping teams execute each step consistently and on time.

Stakeholder Communication

Facilitate clear, ongoing communication with all stakeholders throughout the change lifecycle to keep everyone aligned and informed.

Document Control

Integrate change management with Document Pro to ensure documents linked to change requests are properly controlled and integrated, so users always access the most current approved versions.

Risk Assessment Tools

Leverage built-in risk evaluation tools to assess the potential impact of changes, enabling better-informed and safer decisions.

Integration

Seamlessly connect with other QMS components, including non-conformance reporting, CAPA, inspections, New Product Development (NPD/APQP), and supplier deviation requests.

Configurable Change Form

Classify different types of changes and create custom change management forms to match your organization's structure and workflow needs.

User Validation Form

Include a validation step requiring users to review and confirm all key information in the change request before proceeding. This ensures accuracy, completeness, and accountability early in the change process.

Feasibility Form and Change Notification

Conduct feasibility assessments during initial evaluation and automatically notify relevant stakeholders about upcoming changes. This helps ensure alignment, readiness, and proactive action.

Built for Your Industry

Omnex Change Management Software is designed to adapt to the unique needs of your industry — whether you're building complex products, working under strict regulations, or managing high-volume operations. From design to delivery, it ensures every change is tracked, approved, and implemented without disruption.

Automotive Handle Engineering Change Requests (ECRs) across the product lifecycle. Seamlessly link changes to APQP, DFMEA, PFMEA, and supplier management to meet IATF 16949 and ASPICE requirements.
Medical Devices Support design and process changes with full traceability. Maintain compliance with ISO 13485 and FDA regulations while streamlining approvals, documentation, and risk analysis.
Aerospace & Defense Enable strict control over design, production, and supplier changes. Ensure full auditability and compliance with AS9100 standards and defense sector expectations.

Electronics & High-Tech Manage frequent software and hardware revisions. Keep global teams aligned with real-time updates, automated approvals, and robust version control.
General Manufacturing Simplify change control across shop floors, production lines, and engineering. Reduce downtime and errors by integrating with CAPA, inspections, and document control systems.

With You at Every Step

Implementing change management doesn’t have to be hard — and with Omnex, it isn’t. From the first demo to long after you go live, our team works with you to ensure a smooth rollout, effective training, and long-term success. Whether you're starting from scratch or replacing a legacy system, we help you get it right the first time.

Guided Setup

We tailor the system to your organization’s structure, workflows, and compliance needs. Our experts work directly with your team to configure forms, approval steps, and user roles.

Personalized Training

We don’t believe in one-size-fits-all. You get role-based training for admins, users, and stakeholders — delivered via live sessions, video tutorials, and easy-to-follow guides.

Seamless Integration

Need to connect with existing tools like ERP, PLM, or document management systems? We provide integration support so your data stays connected and consistent.

Ongoing Support

After launch, we stay with you. Our support team is available for technical help, feature updates, and process optimization — because continuous improvement doesn’t stop at implementation.

FAQ

Is this software cloud-based or on-premise?

We offer both options to suit your IT and security needs. Many of our customers choose the cloud version for easier deployment and remote access, while others prefer on-premise installations for tighter internal control. Either way, our team handles setup and support.

Can we customize the change approval process?

Yes — flexibility is a core feature. You can define custom approval workflows, add department-specific stages, and include role-based conditions. The change forms, fields, and routing logic can all be configured to mirror your internal processes without complex development.

Will this help with regulatory compliance?

Absolutely. Our system supports compliance with ISO 9001, ISO 13485, IATF 16949, ASPICE, FDA 21 CFR Part 11, and more. Change records, audit trails, digital signatures, and document control are built in, helping you stay audit-ready at all times.

Does it integrate with our current systems?

Yes — we support integration with ERP, PLM, document control, and other QMS modules. Our team assists in mapping the data flow and ensuring your systems talk to each other, so change data is consistent, synchronized, and easily accessible across departments.

How long does implementation usually take?

Implementation time depends on the size of your organization and complexity of your workflows, but most customers are up and running within 6 to 12 weeks. We provide full project planning, configuration, testing, and training to make your go-live smooth and successful.

What kind of support do we get after launch?

Post-launch, you’ll receive ongoing support from our customer success team. This includes technical help, process optimization reviews, and access to training updates. As your business evolves, we assist with scaling or adjusting the system — because your needs won’t stay static.

Who We Work With

100,000+ globally has embraced Digitalization of Quality

Want to learn more?

Check out our related webinar recordings, Case studies, White papers, & Articles

Digitalization of FMEA, Control Plan, and other APQP/PPAP documents using EwQIMS - Enterprise FMEA Solution

A global leader in the development and production of high-precision bearings for aerospace, defense, medical, dental, and high-tech...

White Paper: Best Auditing Practices using Software

Enterprise today is juggling many standards. An audit tells an organization whether it is adhering to statutory and regulatory requirements and established objectives.

Focus on APQP/PPAP Documentation

The global growth objectives of the customer were hampered by the spreadsheets and silo-based client-server applications that lacked standardization as it is with 75% of the automotive supply base.

Enterprise Quality Management System Software

Digital Transformation of Enterprise Quality

This Automotive Tier-1 wiring harness company was established in 1941 and is one of the world’s leading independent
automotive component manufacturers.

Digitalization of PPAP Documentation Solution Case Study

A global Aerospace organization with several plants in product and process development had challenges with centrally managing all design/process artifacts that were created

The New AIAG-VDA FMEA First Edition White Paper

The AIAG-VDA FMEA Handbook, released in June 2019 has begun to gain popularity in the Automotive Industry globally. Both US and European OEMs have started to require the use

Virtual Supplier Quality Management Solution powered by AI

Managing suppliers virtually with an Enterprise supplier quality solution is a requirement in today’s environment. A “new normal” is emerging where the ability

Change Management in Enterprise Quality Management System