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Change Management in Enterprise Quality Management System

  • Change Management in Enterprise Quality Management System

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
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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.

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Strategy and Evolution of Enterprise Quality and Integrated Management Systems Software
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Challenges of Implementing APQP
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Digitalization of New Product Development
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Enterprise Digitalization of APQP 3rd Edition & Control Plans V.1
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Shift-Left – Integrating Product Risks in New Product Development Using FMEA
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Digital Transformation of Enterprise Quality Management Solution for a Leading Tier-1 Automotive Supplier
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Features and Benefits (Change Management Software)

Change Management

  • Manage critical changes across the Product Life Cycle with a seamless, structured change management process that eliminates disconnects and ensures full traceability.

Automated Workflows

  • Automate the approval, implementation, and review process 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 Revision Control

  • Integrate change management with Document Pro to ensure document revisions are properly controlled and that users always access the most current 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

  • Introduce a user validation form step that requires validation of all key information in the change request before proceeding. This ensures accuracy, completeness, and accountability early in the change process.
Change Management Software

Why Customers Trust Change Management as Their Change Request Management Software

Omnex Change Management is a complete change request management system trusted by organizations worldwide. Our customers switch to Omnex because they’re frustrated with manual processes, fragmented tools, and the risk of lost or incomplete change records. They choose us because we help them automate workflows, maintain compliance, and ensure every change is implemented accurately and on time.

Move Beyond Manual Processes with Automated Workflows: Omnex Change Management automates approval, implementation, and review steps to eliminate manual handoffs and ensure full traceability.

Ensure Compliance and Audit Readiness: Aligns change processes with ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, ISO 13485:2016, and ASPICE standards—maintaining audit-ready records at every stage.
Scalable Integration Across QMS Modules: Seamlessly connects with non-conformance reporting, CAPA, inspections, NPD/APQP, and document control systems for an enterprise-wide view of quality and change.
Expert Support and Ongoing Assistance: Backed by Omnex’s dedicated support team, customers receive personalized training, implementation guidance, and continuous technical and process-optimization help.

Use Cases

  • Engineering Change Requests: Use Omnex Change Management to handle engineering change requests across design, development, and production—ensuring full traceability from request submission through approval and implementation.
  • Supplier Deviation Management: Track, review, and approve supplier deviation requests in real time, maintaining clear communication and compliance with IATF, AS9100, ISO, and ASPICE requirements.
  • Document Revision Control: Automate the revision of SOPs, work instructions, and technical documents with structured workflows and version history—eliminating manual errors and ensuring everyone works from the latest approved files.
  • Mobile & Offline Change Approvals: Empower stakeholders to review, approve, and receive notifications on change requests from any device, even without an internet connection—so critical changes never wait.

  • Regulatory Compliance Management: Align your change processes with standards such as ISO 9001, ISO 13485, ISO 14001, ISO 27001, and ASPICE, while preserving audit-ready records for both internal reviews and external audits.
  • Impact Analysis & Continuous Improvement: Leverage built-in analytics to evaluate the effects of changes on processes, quality metrics, and productivity—driving ongoing improvements and proactive risk mitigation.

What Success Looks Like with Omnex’s Change Management Software

With the right change request management software, success isn’t just measurable, it’s transformative. Experience smoother product lifecycles, faster time-to-market, and greater regulatory confidence by managing every change in a single, intuitive platform. Omnex Change Management turns ad-hoc updates into a predictable, scalable process that drives continuous improvement.

Complete Control Over Your Change Calendar

  • Take command of your change pipeline with end-to-end automation. Omnex Change Management’s scheduling and alert engine keeps every Engineering Change Request (ECR) on track—from initial submission through approval, implementation, and review—so nothing slips through the cracks.

Custom Change Forms, Tailored to Your Process

  • Whether you’re handling design updates, supplier deviations, or document revisions, create and manage change forms that match your exact workflows. Build once, deploy everywhere, and ensure every request captures the right data at the right time.

Mobile-Friendly Change Approvals

  • Stakeholders can review, comment, and approve change requests from any device—even offline. The Omnex mobile app empowers engineers, quality managers, and suppliers to keep changes moving forward, regardless of location or connectivity.

Centralized Change Logs & Instant Reports

  • Say goodbye to siloed spreadsheets and version confusion. Omnex Change Management consolidates every change record, related documents, and approval history in one place. Generate audit-ready reports in seconds to demonstrate traceability and compliance.

Live Dashboards for Total Visibility

  • Monitor open requests, overdue approvals, risk assessments, and implementation progress in real time. Omnex’s dashboards provide actionable insights so you can allocate resources, prioritize critical changes, and prevent bottlenecks.

Built-In Controls for Compliance Readiness

  • From configurable risk assessments to enforced digital signatures and escalation workflows, every element of Omnex Change Management is designed to meet ISO, ASPICE, and industry-specific requirements—so you’re always audit-ready.

Expert Support That Speaks Your Language

  • Our team is more than installers and technicians; they’re quality and change management professionals who understand your challenges. From guided setup to ongoing best-practice reviews, Omnex support ensures you get maximum value from day one.

FAQ

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.

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 needing complex development.

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 version control are built in, helping you stay audit-ready at all times.

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.

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.

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

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