Change Control Software: Qualityze

Introduction

In highly regulated industries, controlling change is critical for maintaining product quality, compliance, and operational efficiency. Uncontrolled changes can lead to compliance risks, process inefficiencies, and costly product recalls. To prevent these challenges, organizations need a structured and reliable system to manage changes effectively. Qualityze Change Control Software provides a cloud-based, scalable, and compliant solution that ensures every change is evaluated, approved, and implemented systematically.

What Is Qualityze Change Control Software?

Qualityze Change Control Software is designed to help organizations manage planned and unplanned changes in processes, documents, systems, and products. Built on the Salesforce platform, it offers a secure and centralized solution for documenting, tracking, and approving changes while ensuring regulatory compliance and complete audit readiness.

This solution is widely used in industries like:

• Pharmaceuticals & Life Sciences
• Medical Devices
• Aerospace & Defense
• Manufacturing
• Healthcare & Biotechnology

Key Features of Qualityze Change Control Software

1. Change Request Management
2. Capture and document change requests with all relevant details for review.
3. Impact Analysis & Risk Assessment
4. Evaluate how changes will affect processes, compliance, quality, and costs.
5. Standardized Workflows
6. Automate review, approval, and implementation workflows to eliminate delays.
7. Role-Based Access Control
8. Ensure only authorized personnel can initiate, review, or approve changes.
9. Integration with Other Qualityze Modules
10. Connect with Document Management, CAPA, Training, and Audit Management modules for seamless change traceability.
11. Regulatory Compliance
12. Stay aligned with global quality standards like ISO 9001, FDA 21 CFR Part 11, and cGMP.
13. Audit Trail & Reporting
14. Maintain complete visibility of change activities for inspections and audits.

Benefits of Using Qualityze Change Control Software

• Improved Compliance: Meet stringent industry regulations with confidence.
• Enhanced Traceability: Track every stage of a change request for accountability.
• Faster Approvals: Eliminate manual delays with automated workflows.
• Risk Reduction: Assess and mitigate risks before implementing changes.
• Continuous Improvement: Enable organizations to adopt changes smoothly for operational excellence.

Why Choose Qualityze Change Control Software?

Unlike traditional spreadsheets or paper-based systems, Qualityze provides a cloud-driven, enterprise-ready platform for managing change efficiently. With advanced automation, seamless integration, and compliance-focused features, it helps organizations control changes across departments, reduce risks, and improve productivity.

Conclusion

Change is inevitable, but uncontrolled change can be costly. With Qualityze Change Control Software, organizations can implement a structured, compliant, and efficient approach to managing change. Whether it’s updating processes, modifying documents, or improving systems, Qualityze EQMS Suite ensures every change is well-documented, risk-assessed, and audit-ready.