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
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
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.
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 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:
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
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.