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8D Management

Turning Issues into Opportunities, 8D Style

To deliver high-quality products organizations employ various methodologies and tools to identify and rectify issues effectively. 8D stands for 8 Disciplines, and it is a problem-solving approach that involves eight key steps: Defining the Problem (D1), Establishing a Team (D2), Identifying Root Causes (D3), Implementing Containment Actions (D4), Implementing Corrective Actions (D5), Implementing Preventive Actions (D6), Monitoring Progress (D7) and Documenting Solutions (D8)

8d Management Software

Elevates Product Quality: Qualityze 8D Management Software

The Qualityze 8D Management Software offers a holistic solution to businesses looking to enhance their product quality, streamline processes, and ensure customer satisfaction. With Qualityze, you're not just getting software; you're embracing a powerful methodology that has proven its effectiveness in addressing quality issues across industries.

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Comprehensive Problem-Solving

Qualityze 8D Management enables you to define problems comprehensively, ensuring that no aspect is overlooked. This approach goes beyond surface-level solutions, digging deep to identify root causes. Qualityze provides a structured and systematic approach to problem-solving and corrective actions. By utilizing the 8D methodology Qualityze with AI infused feature like cross-functional collaboration, real time progress tracking, analysis, coherent notification and alerts, reports and trends, ensures that quality issues are effectively addressed. With its ability to streamline and automate these processes, Qualityze 8D management software enhances efficiency, reduces errors, and promotes continuous improvement, leading to higher product quality and customer satisfaction.

Streamline Approvals with Easy Routing of Any Discipline Task

Qualityze offers a user-friendly solution for efficiently routing and managing tasks assignment and approvals across various disciplines. With Qualityze intuitive interface you can effortlessly assign tasks to the appropriate stakeholders, ensuring accountability and clarity in the approval process. With the Qualityze ability to track the progress in real-time and configurable escalation process, ensures visibility and transparency. This real-time monitoring ensures that approvals are obtained promptly, preventing delays, and maintaining the momentum of your critical processes. Additionally, with cross-functional collaboration capability, you can reduce delays and eliminate bottlenecks optimizing the entire process, making it efficient and hassle-free.

Identify Root Causes and Potential Solutions Using Powerful Investigation Tools

Qualityze8D is a robust solution that empowers organizations to efficiently identify and address the root causes of quality issues. With a suite of powerful investigation tools, Qualityze equips you with the means to delve deep into problems, uncover underlying causes, and chart a path towards effective solutions. Qualityze offers a range of investigation tools, including 5Whys, 5Hows, 5Ws, and 3x5Whys. These tools serve as structured methodologies to dissect issues and understand their core origins helping to unravel complex problems by peeling back the layers to reveal the root causes. By utilizing investigation tools offered by Qualityze, you gain valuable insights into the factors contributing to quality issues enabling you to make well-grounded decisions and devise targeted strategies for improvement. Qualityze 8D Management Software helps you to bridge the gap between identifying problems and implementing effective solutions, ensuring that your actions are precise and impactful.

Evaluate The Effectiveness of Implemented Disciplines for Improvement

Qualityze provides a streamlined solution for evaluating the efficiency of applied disciplines, promoting continuous improvement. Our user-friendly software facilitates seamless assessment of the influence of your actions on quality results. With Qualityze you can easily gauge the effectiveness of disciplines like containment actions, corrective actions, and preventive actions using a range of comprehensive metrics and performance indicators. Qualityze capability to provide real-time insights and a systematic approach to evaluating disciplines, helps you not only meet but exceed quality expectations, enhancing customer satisfaction and competitive advantage. With Qualityze next generation reports and trends, you have access to valuable insights into the outcomes of improvement endeavors at your fingertips, pinpoint opportunities for further enhancement, and make informed choices based on data-driven analysis.

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COQ

We help you save on cost of quality!

Qualityze CAPA Management helps you save on the Cost of Quality. By streamlining and automating your corrective and preventive action processes, it reduces the time and effort spent on issue resolution. Effective root cause analysis, accurate corrective actions, and preventive measures lead to improved product quality, regulatory compliance, and customer satisfaction, resulting in significant cost savings.

Qualityze CAPA Management allows you to save on the Cost of Quality by:

  • Streamlining corrective and preventive actions, reducing manual efforts and administrative costs.
  • Identifying root causes and implementing effective preventive measures to avoid recurring issues.
  • Enhancing collaboration and accountability through streamlined workflows and automated notifications.
  • Improving product quality, regulatory compliance, and customer satisfaction, reducing the costs associated with defects and non-compliance.
  • Providing real-time data tracking and insights to make informed decisions and optimize resource allocation.

Client Testimonials

Qualityze EQMS - Excellent Partnership

We are a Biomed Mems consulting company working with customers who are developing technologies for medical implantable devices. We are a current user of Qualityze EQMS and have recommended and helped two of our customers implement their own Qualit...

Managing Director – Grynova Consulting Group

GreenLight Biosciences (GLB) - Qualityze EQMS Document and Training Management Implementation

Several groups within our organization needed to move out of another vendor’s document and training management program. Qualityze was chosen as a competitive alternative. The Qualityze team was patient with our transition delays and the time...

Jake Criss

Qualityze our incredible partner in QMS

For over a year now, we've embraced Qualityze as our QMS to elevate our quality processes. The team at Qualityze has been exceptionally supportive in addressing our needs and configuring the solutions on the fly. Their innovative and highly adapta...

Tony Yap

Our experience with Qualityze EQMS

From the moment we partnered with Qualityze Inc. for our Quality Management System needs, we knew we made the right choice. The system itself has transformed our quality management practices, providing us with the tools and insights we need to mai...

Daniel Boo

QUALITYZE 8D CORRECTIVE ACTION SYSTEM

Upon searching for Quality software development companies building applications on Salesforce.com, we narrowed the universe of possibilities to three organizations. After spending time with each, Qualityze was the unanimous choice of all Coherent ...

Jack Hunt

Qualityze EQMS Implementation

CavinKare was in search of an EQMS company to create a centralized repository for our technical documents, allowing controlled access to our global factories. During our search, we came across the Qualityze team, who provided us with a comprehensi...

Kalaichelvan Anbazagan

Qualityze EQMS Implementation Experience

My team and I were looking for an audit management system to accommodate a unique audit workflow. Working very closely with the Qualityze technical team, I can honestly say that they were always patient and provided me with clear guidance on how t...

SVP, Advisory Consulting COMPLY

Qualityze - Enterprise Quality Management Solution (EQMS)

Our organization selected Qualityze as our new eQMS system as our previous eQMS process includes the use of multiple systems across the business and associated costs for each. Qualityze provided us with a solution as a system that is highly c...

ZimVie Quality Director

Qualityze EQMS implementation experience and features!!!

Our experience working with the Qualityze implementation and support team was extremely positive. They made sure we understood their base product and the best ways to fit the product to our business processes through configurations to enable ...

Global Quality Assurance Manager

Qualityze eQMS. Excellent Partner for your Quality Journey!!!

The corporation selected Qualityze eQMS system for our Global applications. We started our Qualityze journey in July of 2022 with an aggressive timeline, to implement ten (10) modules over the course of a year. The Qualityze team was great in...

ZimVie Sr. Manager, Doc Control / Training

Qualityze eQMS with Incredible Customer Service!

Our business was faced with tight timelines to go live in a new electronic Quality Management System, and the Qualityze team made it happen! Our business has numerous complexities related to different sites operating under d...

Associate Supplier Quality Manager at ZimVie Spine

Exceeded Our Strategic Goals in an Exceptionally Efficient Manner. All QMS processes in one system!!

We currently have multiple solutions that resulted in us having disparate quality systems to manage with multiple operational challenges. We were looking for a solution that could consolidate all our quality systems into one centralize repository....

Quality Assurance Coordinator, Scholls Wellness

Amazing Cloud EQMS Software!!!!

After looking, viewing demos from several Quality Management Solutions, Qualityze checked off all the boxes of being cloud-based, user-friendly, and totally customizable. The Qualityze team has been very supportive and helped us every step of the ...

Sr. Manager Quality, Care/Of

Thank you Qualityze!

Qualityze has tremendously helped our business fit its complicated model into an electronic quality management system. It has wonderful reporting and dashboard capabilities, as well as being totally customizable to fit our business’s needs. ...

Quality Control Associate, Care/Of

Qualityze, Great Customer Service & Partnership!!!

It has been over a year since implementing Qualityze as a document control system to help streamline, manage and improve our documentation processes, flows and efficiencies. Our implementation team from Qualityze was very helpful and listened to o...

R&D Documentation Specialist, Care/Of

Incredible Value, Incredible Partner

Qualityze drives value through innovation and they are quite dedicated to this. The differentiator for Qualityze is
their outstanding commitment to customer service and innovation. We could not ask for a better partner and it doesn’t hurt...

Director, Quality Assurance & Regulatory Affairs, Kenco Group

Qualityze Helps Bridge the Silo Gap Between Departments and Sites

Qualityze has helped reinforce better relations by bridging the “silo” gap between departments by involving everyone in the process. Qualityze has demonstrated that they are a true business ally for improving quality. Implementation ha...

Network QA Manager, Kenco Group

Qualityze for all your Quality Documentation Needs

We have been using Qualityze at our sites (approximately 60 so far) for about 2 years. We use the system for corporate documents/records and for site level documents/records. One of the best features is the ease of use for the average user. We hav...

Corp Quality Assurance Manager, Kenco Group

Qualityze Drives Innovation and Continuous Improvement with Strategic Partnership

We have a Strategic Partnership with Qualityze. They have been an incredible partner in the configuration and
implementation of the eQMS software. I have participated in several system implementations across multiple platforms and Qualityze is ...

Corporate Quality Assurance Manager, Kenco Group

We chose Qualityze for its simplicity!

Qualityze is an out-of-the-box, ready-to-use, Quality Management System. Since it runs as an independent, Cloud-based application, which is much nicer than trying to expand an expensive ERP system, muddied with a bunch of unwanted ERP features; th...

Quality Coordinator Master Tag Montague, MI

Excellent support shifting audits to Salesforce

I-CAR is a training organization with hundreds of instructors around the country. We regularly evaluate our instructors to provide quality and relevant education to our students. Due to rapid growth over a few years, our home-built system became i...

Manager, Quality Engineering

Excellent Customer Service!!

In our search for Quality Management Solutions, Qualityze stood out from other vendors.  Being built on a Salesforce
platform meant we could integrate our existing data, the screen designs were extremely intuitive and Qualityze provided the fle...

Sr. Technical Specialist, Quality Assurance

Excellent software for document management and QA tasks

In the past, our medical device company struggled to efficiently manage Quality processes such as document management, non-conformances, audits, employee trainings, customer complaints and CAPAs. After a systematic search and assessing multiple QM...

Quality Director, Garreco Dental

Excellent Quality Management System

Qualityze has made our processes much more organized. Everything is in one place, and it is easy to search and run
reports. The Qualityze team has also been extremely helpful as we implement new modules and help find ways to improve processes t...

QA Analyst, Omron Healthcare, Inc

Excellent Quality Management Solution

I manage training and document control. An effective document control system is among the most critical tools for
compliance in highly regulated industries like ours. Document control is essential in QA/RA environments because it
touches all...

Omron Healthcare, Inc

Highly Recommend

Our company has been growing rapidly & we absolutely needed an eQMS solution immediately. Qualityze’s capabilities surpassed our wish list & the modules met our requirements. Implementation has been an ideal transition with guided as...

Chief Regulatory Office, Ortho8

Awesome eQMS for Medical Device Co.

With all the eQMS applications available today, we found that Qualityze was the perfect fit. It wasn’t too stringent
that could potentially bog down our processes, and it wasn’t too simple where it wouldn’t provide value to th...

Ortho8

Qualityze For Our eQMS

With every new product comes the anxiety of, “Will this work? Is it complicated? Will I have support, etc.?” but with
Qualityze and their team, they not only met our needs, but they also surpassed our expectations. Qualityze has pro...

Ortho8

Excellent QMS software

Republic is a manufacturing & engineering company that provides turn-key solutions for Industrial Vacuum Pumps, Blowers, Air Knives, and Custom Metal Fabrication. Due to the scale and complexity of our operations, Non-Conformances and CAPA&rsq...

Republic Mfg

Best Business Partner for QMS

Over the past year Rinchem has implemented several the Qualityze QMS modules to enhance our Quality department. Our Qualityze team has been excellent partners in development and customizations to meet our specific requirements. They have provided ...

QMS Document Control Coordinator, Rinchem Co. Inc.

Nonconformance management benefits to various operational functions

Every business function has unique expectations from a solution, find out what Qualityze can deliver from your functions perspective.

Quality Assurance

CAPA management is closely aligned with quality assurance functions. It enables the identification and resolution of quality issues, ensuring that products or services meet the required standards and specifications.

Risk Management

CAPA management plays a vital role in risk management. It helps identify and assess risks associated with quality issues, allowing organizations to prioritize and implement appropriate corrective and preventive actions.

Process Improvement

CAPA management is an essential tool for process improvement initiatives. It allows organizations to identify process inefficiencies, root causes of problems, and areas for improvement.

Supply Chain Management

CAPA management has a direct impact on supply chain management functions. It helps identify and resolve quality issues within the supply chain, ensuring the delivery of high-quality raw materials, components, or finished products.

Production Management

CAPA management significantly benefits operations and production management. It helps identify process deviations, equipment failures, and other operational issues affecting product quality.

Compliance and Regulatory Affairs

CAPA management supports compliance and regulatory affairs functions. It ensures that organizations meet regulatory requirements by addressing non-compliance issues and implementing preventive actions to prevent recurrence.

Experience Qualityze Difference in managing Quality

We empower organizations to uphold exceptional quality standards while providing the following advantages:

  • Configurable Cloud-Based Platform

    Our system is developed on the world's foremost cloud-based platform, Salesforce.com, which allows businesses to effortlessly personalize it to their exact requirements. It is an adaptable and scalable system that expands in tandem with the growth of your organization. Its wide-ranging configurability broadens the functional scope of an EQMS to an infinite array of creative applications, making it an extremely valuable solution for your organization.

  • Compliance Ready

    Our system adheres to compliance standards for every industry and follows the relevant regulations set by regulatory committees, such as 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), and others.

  • User-Friendly Interface

    Our system design makes it easy for users to accomplish their goals and complete tasks, while minimizing errors and confusion. It considers the needs of various user groups, and provides clear and helpful feedback throughout the user journey. Qualityze strives to create an emotional connection with the user, resulting in increased satisfaction, loyalty, and a positive brand image.

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Frequently asked questions

Answers to commonly asked questions

If you have more questions feel free to reachout to us.

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General

How Qualityze can help me in managing NonConformances?

Qualityze provides a comprehensive Nonconformance Management solution that helps you manage the entire nonconformance process efficiently. The solution streamlines the process of identifying and reporting nonconformance events, tracking the investigation process, and managing the corrective and preventive action (CAPA) plans to prevent similar issues from occurring in the future.

With Qualityze Nonconformance Management software, you can easily comply with industry-specific standards like ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR Part 820, AS9100, and IATF 16949, and ensure that best practices are followed. You can also configure workflows and approval processes to suit your organization's specific needs and get real-time insights into the status of all nonconformance events. This enables you to take prompt corrective actions, reduce the risk of noncompliance, and improve product quality while ensuring customer satisfaction.

How quickly Qualityze EQMS can be deployed in my organization?

Qualityze EQMS can be deployed in your organization in a matter of weeks, depending on the size and complexity of your organization's requirements. Our experienced implementation team follows a well-defined and proven process to ensure a smooth and seamless deployment of the system. We also provide comprehensive training and support to help your team get up to speed with the system quickly.

How can I start using Qualityze EQMS?

To start using Qualityze EQMS, you can follow these steps:

  • Contact Qualityze: You can contact Qualityze through their website, email, or phone to get more information about their EQMS solutions and to schedule a demo.
  • Demo: Qualityze will provide you with a demo of their EQMS solutions, which will help you to understand how the system works and how it can be customized to meet your specific needs.
  • Requirement gathering: Once you have decided to move forward with Qualityze, you will work with their team to gather your requirements, including any specific standards you need to comply with.
  • Configuration: Qualityze will then configure the system to meet your specific requirements, including setting up workflows, forms, and reports.
  • User training: Qualityze will provide user training to ensure that your team is familiar with the system and knows how to use it effectively.
  • Go-live: Once the system is configured and your team is trained, you can go-live and start using Qualityze EQMS to manage your quality processes, including NonConformances.

Compliance

How Qualityze EQMS ensures compliance?

Qualityze EQMS ensures compliance by providing features that comply with industry-specific standards, such as ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR Part 820, AS9100, and IATF 16949. The solution is built on the Salesforce platform, which provides a secure and compliant cloud infrastructure. Qualityze EQMS allows businesses to maintain a complete audit trail of all quality data, ensuring regulatory compliance and reducing the risk of non-compliance.

The software also provides configurable workflows that allow businesses to enforce compliance with their own internal policies and procedures. The workflows can be customized to fit specific requirements and ensure that all processes are standardized and consistent across the organization. The solution provides real-time visibility and reporting, allowing businesses to quickly identify areas of non-compliance and take corrective action. Qualityze EQMS also provides automatic version control and document management features, ensuring that all documents are up-to-date and comply with relevant regulations.

How Qualityze can provide free life time updates? What does “free lifetime update" include?

As a cloud-based solution, Qualityze EQMS is continually updated with the latest features and functionalities to ensure compliance with changing regulations and industry standards. Qualityze provides free lifetime updates to its customers to keep them up-to-date with the latest technology advancements and features. These updates are automatically applied to the system without any additional cost or disruption to the user. Qualityze’s software as a service (SaaS) model allows for seamless integration of new features and bug fixes, which means that customers always have access to the latest version of the software. Qualityze’s dedicated team of developers and quality experts continuously work on enhancing the product to ensure that it meets the evolving needs of the customers and helps them stay ahead of the competition.

What does Qualityze's free lifetime update include?

Qualityze's free lifetime updates include bug fixes, security updates, feature enhancements, and new functionalities. These updates ensure that the Qualityze EQMS solution stays up-to-date and continues to meet the evolving needs of the industry and regulatory standards. The updates are provided without any additional cost to the customers and are automatically deployed to their systems. The Qualityze team ensures that the updates are thoroughly tested before being released to the customers to ensure their smooth integration and minimal disruption to their business operations. The free lifetime updates help customers to leverage the latest technological advancements and ensure that their quality management processes remain compliant and effective.

Security

How secured is Qualityze EQMS?

Qualityze EQMS provides a highly secure environment for managing quality data. It is built on the world’s leading cloud-based platform, Salesforce.com, which has a robust security framework with multiple layers of security features, including:

  • Data Encryption: Qualityze uses AES-256 encryption to secure data in transit and at rest, providing a high level of data security.
  • Role-Based Access Control: Qualityze provides access controls based on user roles, ensuring that users only have access to the data they need to do their job.
  • Two-Factor Authentication: Qualityze uses two-factor authentication to provide an additional layer of security when logging in to the system.
  • Regular Security Audits: Qualityze conducts regular security audits to identify and address any vulnerabilities in the system.
  • Compliance with Industry Standards: Qualityze complies with industry-specific standards such as ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR Part 820, AS9100, and IATF 16949, ensuring that the system meets the highest security standards.

Overall, Qualityze EQMS provides a secure environment for managing quality data, giving organizations peace of mind that their sensitive data is protected.

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