As the new regulation emerges and existing regulations become more stringent, the effort to minimize the loss of quality and managing ongoing changes is very challenging.
Having to keep track of all different types of changes to SOPs, work instructions, design specs, training plans, procedures, formulation etc., without a change management solution is ever growing headache of all companies, big or small.
Qualityze Change Control Management Software system leverages latest cloud technologies to complement your established change management process by
- Initiating and documenting Change
- Reviewing & Approving Change
- Notification of change of impacted users
- Reducing cycle time of change implementation
- Automatic archiving of old revisions
- Ensure regulatory compliance
Qualityze Change Control Management system is integrated with other solutions to create a closed loop Enterprise Quality Management System.
Qualityze powerful analytics and reporting capability helps to perform trend analysis and spot recurring problems quickly and easily. The interactive executive dashboards of Qualityze’s change management and control software provide meaningful change statistics to your c-level management to make an informed decisions to drive continuous quality improvement and meet regulatory compliance needs.
Initiating and documenting Change
As a result of the new or updated regulations, the introduction of new products and services, a software system is updated, impacted procedures, work instructions and step guides needs to be changed quickly and released to be compliant. All the information related to the change request must be documented clearly and concisely.
With Qualityze’s Change Control Management system module, this can be achieved first by creating a change request. Within the Initiation step of a change request, you can capture key information such as:
- Date of change request
- Change request type, title, and description,
- Change request scope and justification
- Priority (High, Medium, or Low). Urgent change management plans may require specific deadlines.
- Change requester, Change Owner and others
Once the change request is created with the necessary information, a unique number will be assigned to help you track throughout the process.
Reviewing and Approving change
A Change request can be initiated by anyone in the organization. However, it needs to be properly reviewed and confirmed for the validity of the request.
In Qualityze’s Resolution step, you have an option to start the approval process to complete this step. If you feel that the change request is not valid you can close out the request. If further processing is necessary you can start the change workflow to complete the request.
Notification of change of impacted users
Once the change request is verified and approved. The appropriate document owner and the users are notified with the change. This early notification will help them to plan the upcoming change.
In Qualityze, once the change request is opened, a change owner, document owner(s) and task owner are notified of the change request. This built in capability provides a real time notification to impacted users and owners.
Reducing cycle time of change implementation
It is absolutely necessary to implement the change on timely manner by reducing the cycle time. The timeliness of change implementation is critical to its success as well as being compliant.
In Qualityze, once the change workflow is started, change task is generated with a due date. The built-in notification and dashboard capability allows you to monitor the progress. In addition, the escalation rule helps to auto escalate the pending and delayed activities to appropriate users to reduce cycle time.
Automatic archiving of old revisions
Archiving of old change request is necessary and required as a part of the change management process. The archived record is your window to the past for changes that were implemented or rejected.
In Qualityze, once the change request is closed out, it cannot be reopened or altered. Every change request will contain the revision of a document that was impacted by the change. Similarly, every document that was changed per the change request(s), will also have the reference back to the change request. This built-in, auto reference feature allows you to easily manage and maintain the historical data related to change request.
Ensure regulatory compliance
It is always a challenge trying to remain complaint in this every changing regulatory environment. In the majority of the organizations, a standard template is used to standardize the change management process. The standardization of the process helps the organization to strive for compliance.
In Qualityze, a change request process has been streamlined and standardized. With built-in workflow, notification, escalations and monitoring capability, it is easy for you to track and take appropriate action. With all these out of the box features, Qualityze change control management software strives to help your organization to remain compliant.
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