Title21 Change Management Solution is easy-to-use, web-based change control software designed for health sciences organizations to ensure change throughout the organization is properly assessed and executed while ensuring high quality operations and control.
Each change control form moves through a workflow including categorization, impact assessment, review, approval and implementation while electronically collecting and storing required documentation.
Each change control form collects the details of the impact assessment and enables electronic notification of all personnel.
All types of changes can be managed in the workflow including equipment, process, supplier, software, labeling, regulations and more.
Revision-controlled documents impacted by the change can be linked to the change control form, enabling the revised documents and the change to go through the approval workflow simultaneously or independently.
Electronic task assignments allow management to assign tasks such as requalification and validation, tracking all change-related operations on the change record.
Management is notified via email and on their dashboard of pending approvals of change control forms and apply their e-signature to approve or reject changes.
Automated workflows, notifications and reporting ensure proper coordination and notification across stakeholders.
Standardization of your change management processes ensure each change is implemented with full control, high visibility and minimal disruption to operations.
Built-in risk assessment tools ensure the risk associated with each change is properly assessed based upon your organization’s risk profile.
Streamlined change management processes and automated workflows reduce bottlenecks and accelerate successful change implementation.