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 Lifesciences

Quality is at the heart of the highly regulated Lifesciences industry. Ever changing regulations and technology are improving the quality of life, though often increasing the complexity of managing business processes. The Quality System requirement for this industry is very stringent. To maintain a robust, flexible and compliant integrated quality management system for lifesciences, quality issues need to be tracked, managed proactively and resolved quickly.

Qualityze, the next generation quality management software for Lifesciences is built on the Salesforce.com platform. A cutting-edge enterprise cloud platform with flexibility, ease of use, risk mitigation and compliance enabled. The solution 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 US FDA (21 CFR part 11, 21 CFR part 820), ISO 13485 standards, Pharmaceuticals and Medical Devices Agency (PMDA), and Therapeutic Goods Administration (TGA).

The Qualityze EQMS software for lifesciences 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 and Maintenance Management with exciting features like Audit Trail, Electronic Signature, Validations, Dashboards, Reports, and Analytics.

Advantages of a Quality Management Software for Lifesciences

Quality Management Software for Lifesciences

The selection of the right life sciences quality management system (QMS) is essential to maintain your organization’s sustainability. It enables you to deliver quality products timely while complying with all the applicable regulatory standards.

The integration of an end-to-end quality management software for lifesciences helps to leverage numerous advantages including:

  • Better Control
  • Compliance with Industry Standards
  • Consistent Production
  • Improved Product Assessment
  • Improved Internal Communication
  • Supplier Management

Better Control

Highly regulated industries like lifesciences treat metrics as their success factors. Maintaining a balance of metrics is significantly important. In addition to that, there is a need to manage the operational risks, internal and external processes, and regulatory compliance while keeping quality a superiority. All these functions can be handled well through a lifesciences quality management software system, which is built to stand firm against the test of time and quality.

Improved Product Assessment

With the ever-growing customer expectations in terms of quality, there is a need of continuous improvement in the practices and processes followed by an organization to enhance product quality especially in the highly regulated industries like lifesciences wherein regulatory compliance like FDA makes an important factor in success evaluation. Only a configurable quality management system can serve the purpose while allowing organizations to configure the product assessment processes with the time.

Compliance with Industry Standards

To help organizations to cope up with the changing terms and conditions of regulatory authorities and attain the specified level of quality, there is a need of a well-structured Enterprise Quality Management System (EQMS) that brings together Quality, Collaboration, Compliance, as well as the Social capabilities. The best way that lifesciences can face the growing complexities of compliance and business models is through a quality management system that works for them.

Improved Internal Communication

A lifesciences quality management system boosts the internal communication in an organization by creating a centralized system to manage their processes. The automation of processes like scheduling a review, follow-up, corrective action etc. eliminates the loopholes of the traditional communication system wherein there are high chances of miscommunication, or delayed information that eventually affects the product quality delivered. It will not be wrong to say that a new generation quality management system can make the communication in an organization smooth and transparent.

Consistent Production

Once you have identified the right way of attaining product quality, it’s wise to stick to that. This helps reducing cost, time, efforts for redoing the things from scratch. You can automate the process once and put things on repetition, as specified under ISO guidelines as well. Consistency and repeatability go hand-in-hand. With automated quality management system, this becomes even more feasible while giving organizations enough flexibility to deal with the upcoming challenges on the way.

Supplier Management

Supplier quality is one of the most prominent yet overlooked aspects of a quality management process. Every organization dealing in lifesciences has an association with some vendors and suppliers to get the required material from. Managing the interaction with them while keeping a track of change or action requests made in a streamlined manner can be easily done with the help of an efficient and effective quality management system that can help to maintain a quality relationship with the supplier while keeping the process and product quality adheres to compliances.

How Does Qualityze Works for Lifesciences?

Qualityze is a fully configurable QMS Software for Lifesciences 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 Lifesciences quality instructions in a simplified manner. Let’s have a look at how each module functions for the Lifesciences:

EQMS software for Lifesciences Industry

How Does Qualityze Works for Lifesciences?

Qualityze is a fully configurable QMS Software for Lifesciences 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 Lifesciences quality instructions in a simplified manner. Let’s have a look at how each module functions for the Lifesciences:

Nonconformance Management

Qualityze Nonconformance Management Software for Lifesciences helps to identify the critical problems that may later evolve as bigger trouble to the organization as well as the customers. We understand that it’s a challenge for the organizations dealing in medical devices and drugs industry. Our solution evaluates the quality of products as per the new requirements specified by the regulatory compliances as well as the organizations to not to leave a single issue unattended. You can also document and evaluate the risks involved to get in the right direction.

CAPA Management

With the configurable Qualityze CAPA Management Software solution for Lifesciences , you can tweak out the root cause of the problems encountered as non-conformance by performing an in-depth analysis even it meant to be through different departments of the organization. The objective it serves is treating the root cause of the problem to avoid its reoccurrence in the near future. The user-friendly interface of our software makes it easy for a user to define action plans in a systematic order, handle review and approvals, implement the action plan, and verify the same. Ours is an integrable solution that you can link to other systems and processes for improved decision making and productivity.

Document ManagementDocument Management

With Qualityze Document management Software for Lifesciences, an organization can experience utmost ease with document management and control processes. Our solution helps with the creation, categorization, review, approvals, release, security, collaboration, and many more functions involved in the document control and management. Comprising a user-friendly interface, our document management solution makes it easy for every user to operate it without any extensive technical training. You can simply create a central repository that can be accessed by everyone from the desired location at the desired time.

Change Management

Qualityze Change management software for Lifesciences is designed to encourage organizations to follow the best practices and to keep the entire change lifecycle smooth and convenient for the workforce. Our solution supports every aspect of change management including initiation, review, approval, execution, verification and validation, and final closure. In addition to all this, Qualityze change management system is easy to integrate with the existing quality management processes and systems in an organization.

Audit Management

To enable businesses to remain compliant irrespective of the complexities especially for highly regulated Lifesciences, Qualityze Audit Management System is the best solution to opt. Our solution is flexible enough to support different types of the audits conducted in any organization to ensure quality processes, products, and services including internal, external, operational, suppliers, IT , and quality audits. Through this efficient system, you can easily manage the entire audit lifecycle from planning to scheduling, defining the standards to preparing checklists, conducting to analyzing audits, tracking the findings and risks to final reporting.

Training Management

Any organization’s effectiveness cannot be boosted without keeping their workforce trained and enabled for the processes and workflows followed in an organization. Qualityze training management system for Lifesciences is designed considering the need for effective training sessions in an organization. Our software helps the organization to manage the training sessions for different personnel with different job functions with the required courses and training documents. And, Qualityze TMS allows easy integration with the existing systems and processes too.

Supplier Quality Management

Qualityze supplier quality management software solution is designed on a cloud-based platform with an easy-to-comprehend interface to offer utmost ease, convenience, and accuracy in the supplier related processes to ensure quality right from the beginning. Our supplier quality management system complies well with different internal as well as external regulatory standards so that only quality products are supplied. Also, you can keep a track of entire supplier data while enhancing collaboration and communication with them.

Complaints Management

Qualityze Complaint Management System is designed to allow the organization to have a loyal customer base by listening and responding to their complaints. Our solution defines a systematic order to track and manage every customer’s feedback in order to ensure that those problems didn’t occur repeatedly especially if the issues identified requires corrective action. With this effective system, you can track every complaint’s lifecycle from documentation to initiation, investigation to reporting till its final closure to ensure that no further loopholes exist.

Why Choose Qualityze Enterprise Quality Management Solution for Lifesciences Industry?

Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Lifesciences 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.