Change Control Software as a Part of an Integrated QMS Solution

Manage changes with precision: A digital, collaborative, and secure change control software for flawless change management
Change Control Software as a Part of an Integrated QMS Solution

What is Change Control Software?

Change control software offers a well-structured approach to mitigate the potential impacts of process modifications or alterations on product quality and regulatory compliance. It enables quality teams to easily document, evaluate, and approve changes before they are implemented.

Effective change control process is a crucial component of quality management. It helps regulated industries mitigate risks, improve traceability, and safeguard the integrity of their products.

Why Choose BizPortals QMS’s Change Control Software?

BizPortals document management and control features, including version control, track changes, and metadata integration, not only help users to effectively store, manage, and access key documents but also support compliance and audit readiness.
Robust Document Control
Utilize a unified platform for all your change-related activities. From initiating change to implementing CAPA and conducting audits, BizPortals change management offers an integrated approach for flawless data transfer, process consistency, and collaboration.
Cross-Module Integration
BizPortals change control solution empowers users to create customizable forms and processes with custom field creation, pre-built templates, multi-stage approvals, permission management, and more to efficiently handle complex changes while maintaining strict regulatory adherence.
Fully Configurable Processes and Forms
Streamlined approval workflow coupled with automated email notifications and alert features ensures clear communication, speeds up the review and approval processes, and facilitates better and more timely decision-making.
Automated Notification and Alerts
BizPortals change control software features a dedicated log with customizable metadata columns, including associated documents, descriptions, departments, status, and more, offering enhanced visibility into stages and progress tracking.
Dedicated Change Control Log
Define and manage access levels based on users’ roles for granular control over the change control process. Easily customize permissions for stakeholders, such as viewing, editing, or approving documents, to minimize risks and avoid unauthorized changes.
Role Management
Facilitate your remote teams to approve and implement changes digitally with the e-signature feature. Use digital signatures to approve change requests, risk assessment reports, and supporting documents to simplify approvals, strengthen compliance, and improve workflow efficiency.
E-Signature for Enhanced Efficiency

BizPortals document management and control features, including version control, track changes, and metadata integration, not only help users to effectively store, manage, and access key documents but also support compliance and audit readiness.

Robust Document Control

Utilize a unified platform for all your change-related activities. From initiating change to implementing CAPA and conducting audits, BizPortals change management offers an integrated approach for flawless data transfer, process consistency, and collaboration.

Cross-Module Integration

BizPortals change control solution empowers users to create customizable forms and processes with custom field creation, pre-built templates, multi-stage approvals, permission management, and more to efficiently handle complex changes while maintaining strict regulatory adherence.

Fully Configurable Processes and Forms

Streamlined approval workflow coupled with automated email notifications and alert features ensures clear communication, speeds up the review and approval processes, and facilitates traceability as required by compliance standards like ISO 13485:2016.

Automated Notification and Alerts

Align your change control software with 21 CFR Part 211 that mandates a detailed change control log. With customizable metadata columns, like associated documents, descriptions, departments, status, and more, it offers enhanced visibility into stages and progress tracking.

Dedicated Change Control Log

Define and manage access levels based on users’ roles for granular control over the change control process. Easily customize permissions for stakeholders, such as viewing, editing, or approving documents, to minimize risks and avoid unauthorized changes.

Role Management

Facilitate your remote teams to approve and implement changes digitally with the e-signature feature. Use digital signatures to approve change requests, risk assessment reports, and supporting documents to simplify approvals, strengthen compliance, and improve workflow efficiency.

E-Signature for Enhanced Efficiency
Explore the Power Behind the Features
Get a live look at how integrated change control works inside BizPortals QMS.

Key Benefits of a Digital Change Control Solution in Quality Management

Enhancing Compliance

Enhancing Compliance

A well-structured and documented change control process helps organizations avoid non-compliance penalties by ensuring that the modifications align with regulatory requirements imposed by industry-specific regulators.

Facilitating Collaboration

Facilitating Collaboration

Cross-functional collaboration is the key to effective change management. A robust change control system offers a unified platform that brings all the stakeholders, documentation, and statistics together for enhanced efficiency and better decision-making.

Risk Management

Risk Management

Modifications in the ongoing process can introduce risks that compromise the quality and safety of the product or service. However, robust change control software lets users proactively identify and mitigate risks, minimizing unintended consequences.

Consistency and Scalability

Consistency and Scalability

Having a digitized process for managing and documenting changes helps promote consistency and scalability within the organization. Users can standardize how modifications are proposed, evaluated, and executed, reducing the chances of errors and variations.

Documentation and Traceability

Documentation and Traceability

Right from detecting issues to executing corrective and preventive actions, each stage is documented and records stakeholders’ actions, providing a clear audit trail for inspections.

Documentation and Traceability

Right from detecting issues to executing corrective and preventive actions, each stage is documented and records stakeholders’ actions, providing a clear audit trail for inspections.

Simplifying Change Control Processes with BizPortals QMS Software

Initiating Change Request

Initiating Change Request

Process changes can stem from factors like new market demands, quality improvements, or addressing existing quality issues. The quality team initiates the process when a need for change is identified. The change control system offers dedicated forms with customizable fields to initiate the change request. Users can add relevant details like proposed changes, description, priority, and department, and add attachments to record complete and accurate change requests.

impact Assessmen

Impact Assessment

The next crucial step is assessing the impact of the proposed changes. BizPortals change control software features a multi-stage change control form that includes a dedicated stage for thorough impact assessment. The initiator can add justifications, impact assessment findings, concerned department, etc., and request further review by the designated authority.

Review and Approval

Review and Approval

The change control process involves multiple reviews and approvals by department heads, regulatory specialists, quality managers, and other stakeholders. However, BizPortals change management enables users to add approval workflows at different stages, track responses, and set notifications and alerts for better decision-making.

Execution & Monitoring

Execution & Monitoring

Once approved, the change control process is ready to implement and may involve updating SOP documents, processes, and products. Creating checklists, setting deadlines, assigning responsibilities, and tracking progress helps quality teams ensure the changes are executed effectively and are compliant with the required quality standards.

Documentation and Closure Business Contract Agreement

Documentation and Closure

Documenting the change control process is essential to improving traceability, ensuring regulatory compliance, and fostering accountability. From initiating to validation and final sign-off, BizPortals change control software helps users record forms and documents at each stage. Furthermore, it offers a dedicated repository to organize change control documents for faster access and future reference.

Simplifying Change Control Processes with BizPortals QMS Software

1 Initiating Change Request
2 Impact Assessment
3 Review and Approval
4 Execution & Monitoring
5 Documentation and Closure

Initiating Change Request

Process changes can stem from factors like new market demands, quality improvements, or addressing existing quality issues. The quality team initiates the process when a need for change is identified. The change control system offers dedicated forms with customizable fields to initiate the change request. Users can add relevant details like proposed changes, description, priority, and department, and add attachments to record complete and accurate change requests.

Impact Assessment

The next crucial step is assessing the impact of the proposed changes. BizPortals change control software features a multi-stage change control form that includes a dedicated stage for thorough impact assessment. The initiator can add justifications, impact assessment findings, concerned department, etc., and request further review by the designated authority.

Review and Approval

The change control process involves multiple reviews and approvals by department heads, regulatory specialists, quality managers, and other stakeholders. However, BizPortals change management enables users to add approval workflows at different stages, track responses, and set notifications and alerts for better decision-making.

Execution & Monitoring

Once approved, the change control process is ready to implement and may involve updating SOP documents, processes, and products. Creating checklists, setting deadlines, assigning responsibilities, and tracking progress helps quality teams ensure the changes are executed effectively and are compliant with the required quality standards.

Documentation and Closure

Documenting the change control process is essential to improving traceability, ensuring regulatory compliance, and fostering accountability. From initiating to validation and final sign-off, BizPortals change control software helps users record forms and documents at each stage. Furthermore, it offers a dedicated repository to organize change control documents for faster access and future reference.

From Change to Compliance—We Cover It All
Explore how our QMS empowers every aspect of quality, not just change control.

How Change Control Solutions Help Industries Manage Compliance and Change

Change control software is applied differently across industries based on their unique processes and compliance requirements. In this use case, we walk through how the automotive industry implements a structured change control workflow using BizPortals QMS.

Inside the Change Management Process – Example from Automotive Industry

Whether in automotive, pharma, or electronics, a SharePoint-based QMS ensures that change is well-controlled, collaborative, and fully traceable—from request to resolution.

Change Control Software vs. Manual Process: Side-by-Side Comparison

See how BizPortals QMS transforms change control—enabling faster approvals, stronger compliance, and full visibility across every stage of the process.
Key Capability Manual Change Control Process BizPortals QMS (Change Control Software)
Change Request Handling
Disparate emails or paper forms; prone to mismanagement
Centralized platform with customizable forms and role-based access
Workflow Configuration
Static, manual steps with inconsistent follow-up
Fully configurable workflows with multi-level approvals and notifications
Audit & Traceability
Limited traceability; hard-to-track records
Built-in audit trails, version control, and e-signatures
Cross-Module Integration
Isolated tracking with no cross-functional alignment
Links changes to CAPA, audit, training, and document control modules
Visibility & Monitoring
Manual updates; limited visibility into change status
Real-time dashboards for status tracking and progress monitoring
Compliance Support
Increased risk of non-compliance and delays
Regulatory-ready templates and digital documentation
Change Doesn’t Have to Be Hard
See how BizPortals QMS makes managing change simple, smart, and stress-free.

FAQs

What is change control, and why is it important to quality management?
Change control is a structured process that ensures all modifications to documents, processes, or systems are reviewed, approved, and documented to maintain quality and compliance. Its key objective is to ensure that all the changes are documented and implemented in a controlled environment.
Organizations operating in regulated industries, such as manufacturing and automotive, require change control software to effectively manage changes to processes, documents, or systems. It is used by quality teams to ensure changes are tracked, approved, and implemented without compromising the compliance requirements and product quality.
BizPortals change control software is part of a comprehensive quality management system, designed to work seamlessly with similar modules, such as CAPA, audit, training, and document control.
A robust change control solution helps identify, evaluate, and document potential risks before any change is approved or implemented. While BizPortals QMS offers cross-module integration, it becomes easy for quality teams to evaluate the consequences of changes and link them with CAPA, audit, and compliance actions—ensuring decisions are informed, traceable, and aligned with regulatory standards.
BizPortals QMS’s change control solution helps automate workflows, configure multi-stage approvals, and assign roles to streamline review and sign-offs. Users can create custom forms, filter requests by type or department, and track them throughout the entire process. Automated alerts notify stakeholders of pending actions, while reports and logs can be easily exported to Excel or PDF for audits or analysis.
BizPortals QMS’s change control solution ensures audit readiness by maintaining detailed records of approvals, change history, and document versions. It supports multi-level approvals, electronic signatures, and automated audit trails to preserve data integrity. With every change logged and traceable, you can easily ensure compliance, maintain audit-ready records, and prepare for regulatory inspections.
In BizPortals QMS, change requests follow a structured, configurable workflow including initiation, impact assessment, review, approval, and implementation. The process can be tailored to meet your industry-specific needs, with customizable stages, roles, and notifications to ensure compliance, traceability, and audit readiness.

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