With the emergence of the new regulations and increasing complexity of the existing regulations, the effort to minimize the loss of quality while managing ongoing changes has become challenging than ever.
Keeping the track of all different types of changes to SOPs, work instructions, design specs, training plans, procedures, formulation, etc., without a change management solution tends to become the headache of all companies – be it big or small.
To relieve companies from the pain of change management, Amzur leveraged the latest cloud technologies in its Change Control Management system that will complement your company’s change management processes by:
Amzur Change Control Management system can be easily integrated with the other solutions to create a closed loop Enterprise Quality Management System.
Amzur comprises powerful analytics and reporting features to perform trend analysis and spot recurring problems quickly and easily. The interactive executive dashboards of Amzur’s change management and control software provide meaningful change statistics to enable your c-level management to make informed decisions that drive continuous quality improvement and meet regulatory compliance needs.
As a result of the new or updated regulations, the introduction of the new products and services, the software system, impacted procedures, work instructions and step guides need to be updated quickly and released to be compliant. All the information related to the change request must be documented clearly and concisely.
And, all this can be easily done by creating the change request in Amzur Change Control Management system module. The Initiation step of a change request allows you to capture key information such as:
Once the change request is created with the required information, a unique number will be assigned to you for tracking the process success until it gets completed.
Once the issue has been identified and recorded, the next step calls for the evaluation and review of the issue to determine the investigation progress regarding the nonconforming material(s).
Exactly what do the Amzur’s nonconformance resolution steps allow you to do? This step gives the NC owner the option to utilize a Risk Assessment for a thorough review and identification of the next steps in the process. If you find that the issue reported is not a valid nonconformance after evaluation and review, you can simply close the record stating the reason. However, you could continue with the NC process by creating a new CAPA or link it to an existing CAPA issue that has been previously identified as a valid nonconformance.
We understand that every nonconformance requires a different level of an investigation depending upon the material-type, component(s) and product(s) involved along with the complexity, suspected or confirmed impact on the product’s performance or intended use.
The Amzur’s Nonconformance Management system software comes with a user-friendly, intuitive interface that allows you to select/de-select the tasks, define task owners and due dates that are necessary for each nonconformance record.
Once the change request is verified and approved. The document owner and the relevant users get notification about the upcoming change. This early notification will help them to plan things accordingly.
Amzur built-in capability provides real-time notification to impacted users and owners. Even if the change request is opened, the change owner, the document owner(s) and the task owner get notified about that change request.
It is necessary to implement the change in a timely manner by reducing the cycle time. The timeliness of change implementation is critical to its success as well as being compliant.
In Amzur change workflow, every change task is generated with a due date. The built-in notification and dashboard capability allow you to monitor the request progress. In addition, the escalation rule helps to auto escalate the pending and delayed activities to appropriate users while reducing the cycle time.
Archiving of the 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.
Amzur Change Management System doesn’t allow reopening or altering the change request, once it is closed out. Every change request will contain the revision of the document that got impacted by the change. Similarly, every document that was altered as 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 relevant historical data.
The ever-changing regulatory environment makes it difficult for any organization to follow the compliances. In most 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 the compliance.
Amzur’s feature-packed module has streamlined and standardized the change request process than before. Its built-in workflow, notifications, escalations and monitoring capability makes it easy for you to track the process and take required action. With all of these out-of-the-box features, Qualityze change control management software strives to help your organization to remain compliant with industry regulatory standards.
Amzur Change Management System works for different industries with the same effectiveness and efficiency. From General Manufacturing to Life Sciences, Pharmaceuticals to Healthcare, Biotech to Metal Manufacturing, Heavy Machinery to Food and Dairy, Automotive to Aviation or Aerospace, Defence to Medical devices, Logistics to Nutraceuticals, our solution makes it easy for your workforce to adopt new changes and maintain topmost quality standards with
Designed on a cloud-based platform, Amzur’s change management software solution is a configurable solution that helps the organization to cope up with the changes in the way more relatable to their ongoing processes. Our solution is flexible enough to adapt to changing organizational needs.
Amzur change management system has in-built check-list templates as defined by the Food and Drug Administration (FDA) – 21 CFR Part 820, International Organization for Standardization (ISO) – ISO 9001, ISO 13485, Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), China Food and Drug Administration (CFDA), etc to serve the specific requirements every industry has.
Having a user-friendly interface, Amzur change management system is easy to operate and manage for the people who are not technically sound. The well-organized structure of our solution makes it easy for users to find out the desired tools and functions.
Change management is an imperative process that needs serious involvement of the workforce in order to adapt the progressive changes at every level that may lead to organizational growth and development. It encourages any organization to:
The Change Management Module from Amzur is designed to meet the ever-changing and continuously growing demands of business operations. Our solution will make your organization change-ready by strengthening the adaptability mechanisms and making it competent for unforeseen situations.
With our new-age software, you can drive organizational excellence by enhancing your workforce understanding of changing customer needs. Amzur helps you keep your workforce informed to ensure every employee is contributing towards the defined business goals and objectives, meeting the demands and expectations of the end-user in a balanced proportion.
Wish to boost your organizational productivity while ensuring the customer needs are met? Amzur Change Management Software is the right solution for you. You can clear all your doubts about the product’s functionality and features by simply requesting a thorough demonstration of our product. You can also get in touch with us on our contact page and we will get back to you at earliest.