A Modern Solution for Managing Changes with Accuracy and Compliance

Change is inevitable in every industry—whether it involves updating processes, modifying products, upgrading equipment, or revising documentation. But unmanaged or poorly tracked changes often lead to compliance issues, operational delays, customer complaints, and increased risks. This is why organizations today rely on digital solutions like Qualityze Change Control Software to ensure every change is controlled, documented, and executed efficiently.

What Is Qualityze Change Control Software?

Qualityze Change Control Software is a cloud-based, enterprise-grade solution designed to help organizations manage changes in a systematic, controlled, and compliant manner. Built on the Salesforce platform, it supports complex workflows, risk assessments, digital approvals, and complete traceability—making it ideal for regulated industries such as manufacturing, pharmaceuticals, medical devices, and food & beverages.

It ensures that every proposed change is evaluated, approved, implemented, and verified in line with industry standards and regulatory requirements.

Why Change Control Is Important

Without proper change control, organizations risk:

• Non-compliance with ISO, FDA, GMP, and other standards
• Production errors and product nonconformance
• Miscommunication between departments
• Audit observations or penalties
• Inefficient workflows and rework
• Safety and quality failures

A structured change control process ensures transparency, accountability, and accuracy—especially when multiple teams and departments are involved.

Key Features of Qualityze Change Control Software

1. Configurable Change Request Workflow

Organizations can define a standardized change lifecycle, including initiation, review, approval, implementation, and closure.

2. Digital Risk and Impact Assessment

Users can evaluate how a change will affect processes, equipment, documentation, training, product quality, or regulatory status.

3. Automated Routing and Approvals

The software automatically routes change requests to the right stakeholders, ensuring no delays and complete accountability.

4. Task and Action Management

Implementation tasks are clearly assigned with deadlines, responsible owners, and status tracking.

5. Full Traceability and Audit Trail

Every action—from submission to closure—is recorded with timestamps and digital signatures for audit readiness.

6. Electronic Signatures & Version Control

Compliant with FDA 21 CFR Part 11, ensuring secure authentication and integrity of change records.

7. Seamless Integration with Other Qualityze Modules

Works cohesively with Document Management, CAPA, Training, Supplier Quality, and more.

8. Cloud-Based, Secure, and Accessible Anywhere

Built on Salesforce, it offers high security, scalability, and mobile accessibility.

Benefits of Using Qualityze Change Control Software

✔ Ensures Regulatory Compliance

Supports key standards including:

• ISO 9001, ISO 13485
• FDA 21 CFR Part 11
• GMP, GLP, GxP

✔ Eliminates Manual Documentation Errors

Replaces spreadsheets and paper-based change tracking with automated workflows.

✔ Improves Visibility Across Departments

Real-time dashboards show pending approvals, bottlenecks, and progress.

✔ Minimizes Risks

Impact assessment prevents unintended consequences before changes are implemented.

✔ Accelerates Change Implementation

Automation reduces turnaround time and improves efficiency.

✔ Strengthens Collaboration

Teams across departments can review, comment, approve, and track changes seamlessly.

How Qualityze Streamlines the Change Control Process

Step 1: Change Request Submission

Employees submit a change request with details like reason, type of change, required documents, risks, and attachments.

Step 2: Impact Assessment

Evaluators analyze the effect on processes, products, documents, training, equipment, and compliance requirements.

Step 3: Review & Approval Cycle

Reviewers digitally approve or reject requests based on established criteria.

Step 4: Implementation

Task owners execute the approved change with clear instructions and deadlines.

Step 5: Verification & Effectiveness Check

Quality teams verify whether the change produced the desired outcome.

Step 6: Closure & Record Archival

All change records are locked securely with electronic signatures and stored for audits.

Why Organizations Prefer Qualityze Change Control Software

• Easy to configure and scale
• Simple and intuitive user interface
• Real-time monitoring and alerts
• Strong integration with other quality systems
• SaaS-based, reducing IT overhead and maintenance
• Faster adoption and training

Conclusion

Effective change control is essential for operational stability, regulatory compliance, and continuous improvement. Qualityze Change Control Software provides organizations with the tools they need to manage changes with precision, speed, and accuracy. Its automated workflows, thorough impact assessments, and complete traceability make it a powerful solution for modern businesses that cannot risk uncontrolled changes.

With Qualityze EQMS Suite, companies can ensure that every change is properly analyzed, approved, implemented, and verified—leading to better quality outcomes and sustainable growth.