Qualityze Inc attends ISO 9001 and Audits World Conference, gains valuable insights on quality management and auditing!
Tampa, FL USA, 23rd March 2023: Qualityze is pleased to announce our recent participation in the ISO 9001 and Audits World Conference. The event took place on March 13-14, 2023 and brought together professionals around the globe to discuss quality management and auditing. The ISO 9001 and Audits World Conference is a premier event in […]
Change Management: – Embrace the Challenge of Managing Change
“The only constant is change,” is a quote credited to Heraclitus. While this Greek philosopher knew nothing about our modern-day quality management systems, more than 2,000 years later we recognize the wisdom of his words in the way we manage quality.
Over those thousands of years we have witnessed an acceleration in the rate at which we communicate. Society has advanced from smoke signals, carrier pigeons and the Pony Express to the telegraph, fax machines, email, social media platforms, and mobile communications. All of these advances have resulted in the speed-up of change. Indeed, in today’s digital age we are surrounded by more frequent and rapid changes beyond just communications. Consider the rapid rate at which we developed vaccines for COVID-19 in months versus years as well as the stunning speed at which consumers are taking charge of their own health via mobile medical apps (MMAs). Regulatory bodies have had to respond to these technological advances to keep up with societal change.
Given these new digital realities and advances in regulatory oversight, progressive organizations are upgrading their Change Management systems. Paper-based approaches and disparate systems connected with complex integrations are ill-equipped to handle the myriad changes bombarding the enterprise today. Our – Change Management solution capture, analyze, and implement change(s), and confirm their effectiveness, to ensure you are complying with regulatory standards and guidelines.
As organizations seek to maintain compliance with current rules and standards while also keeping up with the continuous emergence of new regulations, they are struggling to manage change on a day-to-day basis. Qualityze Change Management delivers standard processes to help you record, review, approve, and implement new change requirements in an integrated manner. In this way, you can minimize the change cycle time and its impact on your everyday operations.
Qualityze Change Management standardizes the process to:
- Initiating and Documenting Change
- Reviewing and Approving Change
- Notification of Change to Impacted Users
- Reducing Cycle Time of Change Implementation
- Automatic Archiving of Old Revisions
- Ensure Regulatory Compliance
Change Management Overview
Whether it is a document change, product change, process change, or any other changes in the business systems and facilities, you need a standardized change management processes to address your business growing requirements. Qualityze Change Management Software is specifically designed to prepare organizations for all the change-related challenges and make every change a smooth transition. With Qualityze Change Management, you can effectively and efficiently:
- Create Change Template
- Initiate Change Request
- Manage Document Versions
- Manage Product Change
- Create New Product/Document
- Manage Pre/Post-Change Approvals
- Implement Change
- Validate with Digital Signature
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Initiating and Documenting Change
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 Qualityze Change Control Management System module. The Initiation step of a change request allows you to capture key information such as:
- Change request type, title, & description,
- Change request scope & justification
- Priority (High, Medium, or Low). Urgent change management plans may require specific deadlines.
- Change requester, Change Owner & others
- Date of change request
Once the change request is created with the required information, a unique number will be assigned to you for tracking the process success till it gets completed.
Reviewing and Approving Change
Anyone in the organization can initiate a Change request. However, it needs to be appropriately reviewed and confirmed for the validity of the request.
In Qualityze’s Resolution step, you have an option to start the review and approval process. If you feel that the change request is not valid, you can close out the request.
If further processing is required, you can start the change workflow to complete the request.
Reviewing and approving change requests often ensure that all the changes are carefully evaluated for their impacts and processed for implementation.
Notification of Change to Impacted Users
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 and stay prepared.
Qualityze 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.
Sending change notifications encourages smooth communication and engagement among your team, increasing their productivity. Most importantly, you are less likely to face resistance from your quality teams when you help them understand the value of change within time.
Reducing Cycle Time of Change Implementation
It is necessary to implement the change in timely manner by reducing the cycle time. The timeliness of change implementation is critical to its success as well as being compliant.
In Qualityze 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.
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.
Qualityze Change Management Software don’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.
Ensure Regulatory Compliance
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.
Qualityze’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.
Why Change Management Is Important?
Change management is a necessary process that needs to be woven into various functions (e.g., document management, risk management, design control, new product development). This approach to change management allows the organization to efficiently grow and develop. Indeed, it encourages any organization to:
- Have a better understanding of evolving customer needs
- Establish best practices for the long-term based on its objectives and goals
- Define and harmonize its operational workflows and regulations
- Pursue excellence in business performance
How does Qualityze Change Management Help Businesses?
Any regulations required by FDA, ISO, or EU Annex 11 make change control critical to your operations. Qualityze Change Management helps you create a standard process to record, review, approve and implement change. As alluded to earlier, documents, design control and myriad other organizational changes can be better managed with Qualityze while mitigating operational and compliance risks.
With Qualityze Change Management, you can:
- Document Organization-Wide Change Requirements/Requests
- Analyze and Notify the Change Impact
- Effectively and Efficiently Implement Change
- Integrate with Existing Business Systems
- Improved Decision Making
- Gain Visibility of Changes
- Controlled Change Records and Data
Document Organization-Wide Change Requirements/Requests
Qualityze Change Management comes with user-friendly forms to record organization-wide change requests. These forms include details like Date of Change Request, Change Request Type, Title, and Description, Change Request Scope and Justification, Priority (High, Medium, or Low), Change Requested By, Change Owner, and much more. The configurable workflows allow you to capture change requests consistently and efficiently. You can configure business specific forms and generate unique reference numbers that enable you to track your change requests’ progress and status.
Analyze and Notify the Change Impact
With Qualityze Change Management, you can analyze the impact of every change request impacting document, products, processes, or operations across your organization. You can effectively communicate the change requirements and their impact on the parties involved so that changes can be approved and implemented smoothly. A detailed analysis will help you formulate action plans required for each change request.
Effectively and Efficiently Implement Change
Qualityze Change Management helps you efficiently manage all the processes associated with different change requests. You can create consistent and repeatable change workflows for every change, ensuring that each request follows a standardized process. This generally includes initiating a change request, analyzing its impact, communicating with impacted users, performing timely reviews and approvals, documenting each step, and managing the change implementation. Each change can be thoroughly reviewed and approved to increase the likelihood of a compliant change process.
With Qualityze Change Management, you can collaborate with your quality teams regarding change requests, reviews, approvals, effectiveness checks, and other critical decisions. With our centralized, integrated change management system and parallel workflows, we can help you reduce the change implementation cycle time.
Integrate with Existing Business Systems
Qualityze Change Management can integrate with your existing business systems and third-party applications to process changes related to defects, documents, audit findings, customer complaints, and other issues, by creating a consistent and compliant workflow. The alerts and notification features allow you to alert your teams about upcoming changes that need their attention.
Improved Decision Making
Qualityze Change Management includes reports and dashboards that conform with your business-specific requirements. You can quickly configure reports to analyze data using advanced reporting tools and to retrieve real-time information to make business critical decisions. Fact-based decisions made on real-time data help to accelerate your business growth.
Gain Visibility of Changes
With Qualityze Change Management, you can gain improved visibility by monitoring your change requests and their status. Our auto-generated reference numbers give you the flexibility to track the progress of change requests, especially those with high priority. Our color-coded icons help you to quickly understand “WHERE AM I” in the managed workflow process.
Visibility is enhanced with our Chatter functionality which provides a real-time, collaborative platform for posting and commenting. The number and length of multiple email chains can be reduced, saving time and minimizing frustration.
Controlled Change Records and Data
Qualityze Change Management standardizes the change process cycle, keeping all your quality data and records securely stored on a centralized cloud platform. You can ensure more security for your change control records with role-based Security Controls, Password Authentication, and Audit Trail. Documenting and maintaining change records makes it easier to comply with regulatory standards, including FDA 21 CFR Part 11 and EU Annex 11. It also helps to demonstrate that best practices are followed in your organization to drive continuous improvement.
Qualityze Change Management – Standardizing Your Change Control Processes
Qualityze Change Management works for every industry — including Manufacturing, Life Sciences, Pharmaceuticals, Medical Devices, Cannabis/Hemp/CBD, Nutraceuticals, Biologics/Biotech, Food and Beverages, Automotive, Aerospace, Defense and Logistics — to manage organization-wide changes effectively while ensuring compliance with applicable regulatory standards.
Qualityze Change Management Solution comes with a(n):
- Centralized Change Database
- Audit Trail
- Configurable Workflow and Fields
- Reports and Dashboards
- Alerts and Notifications
- E-Signature Validation
- Seamless Integration
- Chatter
Qualityze EQMS – The Enterprise Quality & Compliance Management Platform to Manage, Control, and Track Critical Changes
Change control management improves product quality and safety while aiding with compliance to regulated environments. Our Qualityze Change Management Process streamlines and standardizes the change management process, from initiating a change request to implementation and closure. Our solutions support validation services, making software upgrades cost-effective. The configurable workflows make it easy for you to align each change with required steps, eliminating unnecessary activities from the workflow, and ensuring timely change implementation. These consistent workflows and embedded best-practices support a culture of quality, safety, and compliance.
Qualityze EQMS Suite helps enterprises align their quality processes with their business objectives while mitigating operational challenges. Built on the most powerful and secure cloud platform, Salesforce.com, Qualityze provides unparalleled benefits to manage your organizational changes. We empower you to optimize your quality processes by giving you the control and confidence in managing your change requirements, allowing you to focus on business growth opportunities.
Qualityze prepares you to succeed with a next-generation approach to implement organizational changes quickly and effectively while lowering the impact of changes on operational excellence and productivity.
Experience Qualityze Difference to Optimize Quality
Qualityze EQMS Suite enables you to maintain high quality standards while experiencing difference with:
Configurable Cloud-Based Platform
Designed on a cloud-based platform, Qualityze’s Change Management Software Solution is a configurable solution that help the organization to cope up with the changes in the way more relatable to their ongoing processes. Our solution is flexible enough to adapt the changing organizational needs.
Adherence to Compliance Standards
Qualityze 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.
User-Friendly Interface
Having a user-friendly interface, Qualityze 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 the users to find out the desired tools and functions.
Establishing Organizational Best Practices for Changing Needs to Retain Leadership in Market
The Change Control Management Software from Qualityze 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 towards changing customer needs. Qualityze eQMS Software 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? Qualityze 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.
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