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.

Quality Management System for Medical Devices

For the medical devices industry wherein quality and highly regulated environment are a must, you cannot rely on the traditional quality management systems. Since most of those QMS is merely a combination of some general-purpose tools and paper-based processes, bonded together by a group of people more like a loosely held system. The lack of accountability and traceability are the key factors that make such medical device QMS ineffective. Hence, there is a need for powerful QMS for medical devices industry that can manage all the quality processes within a closed-loop system.

Qualityze, the next generation quality management software for medical device industry is built on the Salesforce.com platform. A cutting-edge enterprise cloud platform with flexibility, ease of use, risk mitigation and compliance enabled. The QMS for medical devices companies provides you with a closed loop EQMS system that enables you to be compliant with internal and external regulations. Qualityze enables you to comply with ISO 13485 standards US FDA (21 CFR part 11, 21 CFR part 820), Therapeutic Goods Administration (TGA), and Pharmaceuticals and Medical Devices Agency (PMDA).

The Qualityze EQMS software for medical devices is a closed-loop quality system which includes Document Management, Change Management, Nonconformance Management, CAPA Management, Audit Management, Training Management, Complaints Management, Supplier Quality Management, Calibration Management, Maintenance Management with exciting features like Audit Trail, Electronic Signature, Validations, Dashboards, Reports, and Analytics.

Advantages of a Quality Management Software for Medical Devices Companies

Quality Management Software for Medical Devices

The precision of design and manufacturing is a must in the medical devices industry as they can be of huge impact on lives for the good or worse. Quality standards are critical to reaching high levels of product reliability in production.

You must adhere to ISO 13485 in order to meet all the quality management system standards for medical devices. Here’s an overview of all the benefits that you can leverage with the integration of an end-to-end quality management software for medical devices:

  • Effective and Faster Cycles of Execution
  • Increased Customer Satisfaction
  • Elevated Market Value
  • Reduced Amount of Waste
  • Streamlined Process Improvements
  • Improved Supplier Relationships

How Does Qualityze Works for Medical Devices Industry?

Qualityze is a fully configurable QMS Software for medical devices industry that helps to standardize the processes and workflows to meet the quality specification highlighted by the regulatory compliances, ensuring customer satisfaction. With 8 different modules, Qualityze is an EQMS suite that deals with complex medical devices quality instructions in a simplified manner. Let’s have a look at how each module functions for the medical device industry:

EQMS software for Medical Devices Industry

How Does Qualityze Works for Medical Devices Industry?

Qualityze is a fully configurable QMS Software for medical devices industry that helps to standardize the processes and workflows to meet the quality specification highlighted by the regulatory compliances, ensuring customer satisfaction. With 8 different modules, Qualityze is an EQMS suite that deals with complex medical devices quality instructions in a simplified manner. Let’s have a look at how each module functions for the medical device industry:

Nonconformance Management

Having Qualityze Nonconformance Management Software for medical device companies is a perfect solution to identify and document the nonconformances in a well-organized and structured manner. Since it’s still a challenge for the organizations dealing in medical devices and drugs industry, our solution is equipped with all the features that you may need for quick documentation as well as the search of a non-conformance record. Qualityze enables you to do a detailed evaluation of product quality while complying up with the regulatory standards and company standards for tracing every single nonconformance. This cloud-based solution also helps you to specify the desired action plan for a nonconformance based on its risk severity issue to classify the ones to be processed under CAPA.

CAPA Management

Qualityze CAPA Management Software for medical devices comes with configurable workflows so that you can implement the best root cause investigation tools to identify the actual cause of the problems already occurred. You can also identify the potential causes that can result in quality issues to make a proactive approach with our advanced CAPA management software. The user-friendly interface of the software eases managing the entire CAPA cycle for you from root cause identification to implement action plans and check their effectiveness. Moreover, ours is an integration-enabled solution for improved decision making.

Document ManagementDocument Management

Medical device industry, unlike any other industry, has much more complex documentation to handle including design instructions, SOPs, specifications, manuals, and much more to ensure all the regulatory guidelines are followed. Qualityze document management solution for medical devices is designed to help you with the creation, categorization, review, version control, approvals, release, safety, collaboration, and many more document control and management functions for such complex documents. Ours is an intuitive ISO 13485 QMS software to help manage all the critical documents in a centralized repository without extensive technical training.

Change Management

With Qualityze Change management software for medical devices, your organization will have a smoother transition through the changes implemented due to ever-growing customer requirements and ever-changing regulatory standards. Our solution helps you to keep your workforce informed about new changes so that they can implement best practices for introducing change without facing any resistance. Our solution can help you with every aspect of change management from initiation, verification and validation, review, approval, execution, till final closure. Moreover, you can integrate this with other quality systems for the finest flow of changes.

Audit Management

Keeping medical devices companies compliant with the complicated regulatory standards becomes easy with Qualityze Medical Devices Audit Management System. It is a cloud-driven solution that offers unmatched flexibility and scalability for different types of audits including internal, external, operational, suppliers, IT, and quality audits. The main objective is to ensure quality processes, products, and services. It’s quite efficient to help you manage the end-to-end audit lifecycle – planning and scheduling audits, defining the regulatory standards to prepare checklists, conducting and analyzing audits, tracking and analyzing the final audit results.

Training Management

Keeping organizational productivity and efficiency to the maximum is only possible when the employees are competent and trained enough to perform the designated responsibilities. Considering the criticality involved in medical devices, Qualityze Training Management Software is designed to implement effective training sessions for your workforce. From creating course and employee profile till course completion and certification, you can track the complete progress of your employees. Serving training needs for your employees will keep them motivated and engaged in business goals achievement.

Supplier Quality Management

Built on cloud platform i.e. Salesforce.com, Qualityze supplier quality management software is the best solution to manage all your supplier related tasks from creating supplier records to monitor their performance on a regular basis. The ease, convenience, and accuracy that Qualityze offers are incomparable. Most importantly, our supplier quality management software complies with different internal and external regulatory standards in order to ensure quality supply chain processes. Moreover, you can leverage a centralized platform to improve collaboration and communication with all your suppliers.

Complaints Management

Transforming customer complaints into improvement opportunities is a need for every industry especially the medical device industry. Qualityze Complaint Management System helps you do exactly what you need to maintain a healthy relationship with your loyal customers. It allows you to track and manage every customer complaint/feedback in a systematic order so that you can deal with them effectively and limit their recurrence especially the issues that qualify for CAPA investigation. It is the most effective system to manage entire complaint lifecycle including documentation, initiation, investigation, reporting, and closure.

Why Choose Qualityze Enterprise Quality Management Solution for Medical Devices industry?

Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Medical Devices industry because it has

Still Thinking?

Qualityze EQMS has a lot of value to offer to any organization with its customizable cloud-based software for Nonconformance Management, CAPA Management, Document Management, Change Management, Training Management, Supplier Quality Management, Complaints Management, Calibration Management and Maintenance Management..