Qualityze Achieves ISO 9001:2015

Tampa, FL – January 30, 2020 – Qualityze, Inc. has been certified as ISO 9001:2015 – compliant after an in-depth audit of the company’s internal operations.

Change Management : Embrace the Challenge of Managing Change

“Change is the Only Constant,” even in the way we manage quality. As email, social media platforms, and mobile communications have become standard communication methods its driving new norms for communicating with each other in our personal and professional relationships, an easy example today is nobody writes letters anymore. In this age of digital revolution, we are surrounded by more efficient means of doing business.

It is time you consider upgrading your Change Management system. Our next-generation Change Management solution will capture, analyze, and implement change(s), confirm their effectiveness, to ensure you are meeting compliance with regulatory standards.

The continuous emergence of new regulations and maintaining compliancy with existing rules and standards has increased the challenge to manage change on a day to day basis.

Qualityze Change Management delivers standard process to record, review, approve, and implement new change requirements. You minimize the change cycle time and its impact on your everyday operations.

Qualityze Change Management standardizes the process to:

  • Initiate and Document Change Request
  • Review and Approve Change Request
  • Notify the Change to Impacted Users
  • Reduce Change Implementation Time
  • Ensure Compliance with Regulatory Standards

Change Management Overview

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 Solution leverages latest cloud technologies to complement your established change management process by

  • Initiating and Documenting
  • Change Reviewing & Approving
  • Automatic archiving of old revisions
  • Notification of Change to Impacted Users
  • Reducing cycle time of change implementation
  • Digital Signature
  • Audit Trail
  • Notification & Alerts
  • Ensure regulatory compliance

Change Control Management and Tracking Software Systems

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.

Change Management System Software

Reviewing and Approving Change

Change Management Software Systems

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.

change control software

Reducing Cycle Time of Change Implementation

cloud based change management software

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.

Change Control Management solution

Ensure Regulatory Compliance

Change Control Management Software

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 serious involvement of the workforce to adapt the progressive changes at every level that may lead to organizational growth and development. It encourages any organization to:

  • Have Better Understanding of Changing Customer Needs
  • Establish Best Practices for Long-Term Based on Objectives and Goals
  • Define the Operational Workflows and Regulations
  • Attain Excellence in Business Performance

How does Qualityze Change Management Help Businesses?

Any regulations required by ISO, EU Annex 11 or FDA makes change control a very critical to your operations. Qualityze Change Management helps you create a standard process to record, review, approve and implement change.

So, make a confident move to manage documents, processes, and all types of organizational changes 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

Enterprise Change Management

Qualityze Change Management comes with user-friendly forms to record organization-wide change requests. They 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 consistently and efficiently capture change requests. You can configure business specific forms and generate unique reference numbers that enables 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, regarding documents, products, and processes, on other operations across the organization.

You can effectively communicate the change requirements and their impact on the involved parties so that changes can be approved and implemented smoothly.

A detailed analysis will help you formulate action plans required for each change request.

Change Management & Implementation software

Effectively and Efficiently Implement Change

Change management software solution

Qualityze Change Management helps you efficiently manage all the processes associated with different change requests. You can create consistent and repeatable change workflow for every change, ensuring that each request follows a standardized process.

It generally includes initiating a change request, analyzing impacts, communicating with impacted users, performing timely reviews and approvals, documenting every step, and managing the change implementation. Each change thoroughly reviewed and approved ensures 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. It further reduces 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 notifications capability allow you to alert your teams about upcoming changes that need attention.

Document Change Control Software

Improved Decision Making

Change Control Tracking Systems

Qualityze Change Management has reports and dashboards to conform to your business-specific requirements. You can quickly configure reports to analyze data using advanced reporting tools to retrieve real-time information to make business critical decisions.

The fact-based decisions made on real-time data accelerate your business growth.

Gain Visibility of Changes

With Qualityze Change Management, you can gain improved visibility through monitoring your change requests and their statuses’.

Our auto-generated reference numbers give you the flexibility to track the progress of change requests, especially those with high priority.

View our color-coded icons to quickly understand “WHERE AM I” in the managed workflow process.

Change Control Software Systems

Controlled Change Records and Data

change management process

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 helps meet compliance with regulatory standards, including FDA 21 CFR Part 11 and EU Annex 11, It also helps demonstrate best practices followed in your organization to drive continuous improvements.

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

  • Centralized Change Database
  • Audit Trail
  • Configurable Workflow and Fields
  • Reports and Dashboard
  • Alerts and Notifications
  • E-Signature Validation
  • Seamless Integration
  • Chatter, and more.

Qualityze EQMS – The Enterprise Quality & Compliance Management Platform to Manage, Control, and Track Critical Changes 

Change control management improves product quality and safety while ensuring compliance in regulated environments. Qualityze Change Management Process streamlines and standardizes the change management process, from initiating a change request till implementation and closure. Our solutions support validation services, making software upgrade 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. Such consistent best-practices helps to create 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 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.