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BizPortals Change Control Software

Manage changes with precision: A digital, collaborative, and secure change control software for flawless change management
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Change Control Software

What is Change Control in Quality Management?

Change control in quality management refers to a well-structured approach to mitigate the potential impacts of process modifications or alterations on product quality and regulatory compliance. It involves documenting, evaluating, and approving changes before they are implemented.
Effective change control is a crucial component of the quality management process. It helps regulated industries to mitigate risks, improve traceability, and safeguard the integrity of products.

Change Control Features in BizPortals QMS

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.

BizPortals 365 Intranet

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.

BizPortals 365 Intranet

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.

BizPortals 365 Intranet

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.

BizPortals 365 Intranet

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.

BizPortals 365 Intranet

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.

BizPortals 365 Intranet

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.

BizPortals 365 Intranet
  • Robust Document Control
    -->

    A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.

    Read More
  • Cross-Module Integration
    -->

    A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.

    Read More
  • Fully Configurable Processes and Forms
    -->

    A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.

    Read More
  • Automated Notification and Alerts
    -->

    A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.

    Read More
  • Dedicated Change Control Log
    -->

    A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.

    Read More
  • Role Management
    -->

    A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.

    Read More
  • E-Signature for Enhanced Efficiency
    -->

    A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.

    Read More

Change Control Process Flow: From Initiating Change to Final Sign-off

1

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. Change control software 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.

2

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.

3

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.

4

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.

5

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.

Change Control Process Flow: From Initiating Change to Final Sign-off

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. Change control software 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.

1

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.

2

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.

3

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.

4

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.

5

Importance of Change Control Software in Quality Management Process

Customized Dashboard

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.

Permission-Based Access

Risk Management

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

easy-check-incheck-out

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.

versioning

Documentation and Traceability

Documenting each stage of the change control process ensures that every change, such as approvals, impact assessment, and stakeholder engagement, is captured in detail, promoting traceability and audit preparedness.

versioning

Facilitating Collaboration

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

Zip Doc

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.
Schedule a Demo

Take control of your changes with BizPortals change control software for enhanced compliance, risk management, and operational efficiency.

Other Dedicated Modules Offered by BizPortals QMS

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CAPA Management

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