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Quality Management System for Biotechnology Industry

For every biotechnology company, it is critical to attaining quality assurance throughout the manufacturing process. From managing SOPs to work instructions and specifications, nonconformances to CAPAs, audits to change controls, and customer complaints, there is a need for Quality Management Solution for the streamlined and effective production process. Also, a QMS must ensure meeting compliance standards while analyzing critical information for continuous improvement with the time.

Qualityze is the next-generation quality management software designed on Salesforce.com platform to give biotechnology companies a competitive edge with flexibility, scalability, and ease of use. This compliance enabled quality management solution to mitigate quality risks while maintaining consistent product quality. It also enables you to form a closed-loop EQMS system to meet internal and external regulatory standards including ICH and ISO.

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

Advantages of a Quality Management Software for Biotechnology

Quality Management System for Biotechnology

Biotechnology companies have witnessed a trend of evolution especially in the manufacturing requirements, which can be effectively managed with the implementation of a comprehensive quality management system.

Here’s an overview of all the benefits that you can leverage with the integration of an end-to-end quality management software for biotechnology companies:

  • Improved Business Processes
  • Improved Customer Satisfaction
  • Better Decision-Making Process
  • Culture of Continuous Improvement
  • Increased Employee Engagement
  • Improved Supplier Relationships

Improved Integration of Processes

With the successful integration of a quality management system, you will be able to do process integrations in an improved way. This will enable you to identify much more improvements in terms of productivity and cost-effectiveness. Once the processes will be maintained without lack of efficiency, you will be able to reduce the amount of wastage especially the ones arise as a result of process handoff. The improved process implies lesser rework and errors that pumps up the cost savings.

Culture of Continual Improvement

Having an ISO certified quality management solution itself implies that your biotechnology company has adopted the culture of continuous improvements for all the processes and the end product quality. The process of improvement starts with the inclusion of systematic process flow that mitigates the overall impact of the problem while helping in the speedy recovery of the problem/issues/deviations already occurred. Maintaining the continuity of improvements will result in the continuity of the benefits.

Improved Customer Satisfaction

One of the most prominent advantages of implementing a powerful quality management solution is improved customer satisfaction since you can improve the planning process. If you strive to meet customer requirements, you will have more repeated customers as keeping your customers happy and satisfied is key to maintain a loyal customer base. Also, happy customers tend to recommend your brand more often. Hence, focus on customer satisfaction for improved revenue and brand recognition.

Increased Employee Engagement

Keeping your employees involved in the process improvements especially the ones they are part of is a key to keep them happier and engaged. In fact, no one can help you improve than the people who are already working on those processes as they know the areas that need improvement. They can also help in testing and implementing those improvements. Increased engagement of employees is directly proportional to their productivity, which will improve organizational effectiveness. The involvement of employees will be a positive move as they will understand that process quality depends on them.

Better Decision-Making Process

Another great benefit of implementing a robust quality management solution is improved analysis of the business-critical information that helps you make improved decisions for every business process. You cannot expect the “Guesswork” as a successful strategy for making a critical decision. You need to process real-time data analytics to make a fact and evidence-based approach for the informed decision-making. Quality of the decisions you make for your business can make or break your business success.

Improved Supplier Relationships

Improving relationships with the suppliers is the most overlooked concept that actually requires utmost attention since it’s the foundation for a quality product. Once you implement a quality management system that streamlines all your processes including supplier quality management in a closed-loop, you can maintain good supplier relationships while monitoring their performance and material quality on a regular basis. Your feedback may help them improve material(s)/component(s) quality, which as a result will benefit you.

How Does Qualityze Works for Biotechnology Companies?

Qualityze is a powerful and secure QMS software for Biotech firms that helps to build a standardized process for quality management while mitigating compliance and quality issues. It enables you to follow best practices in order to meet customer and compliance requirements. A suite of 8 different products, Qualityze enables biotechnology companies to maintain quality quotient in a simplified manner. Let’s have a look at how each module functions for the biotechnology companies:

Nonconformance Management

With the expansion of biotechnology companies on a global stage, public credibility has become as important as regulatory standards in regard to the internal processes and operations. Maintaining credibility is only possible when you keep a check on nonconformances/deviations/quality issues, which is particularly challenging in the ever-changing environment of such highly regulated industries. Qualityze Nonconformance Management System Solution is designed keeping all such complexities and criticalities in consideration. It is equipped with advanced features that you need to meet regulatory standards while attaining product quality.

CAPA Management

In a highly regulated environment like Biotechnology, you need a level of root cause investigation that can commensurate with the level of risks associated with a quality issue. In fact, your CAPA system should be effective enough to trigger product and process improvements for better products and processes respectively. Qualityze CAPA management solution enables you to establish a powerful CAPA system that can serve the intended purpose without any hassle, meeting the industry-specific regulatory standards. It also allows you to configure suitable investigation tools that match your business processes and objectives best.

Document ManagementDocument Management

Biotechnology companies need to maintain a wide range of documents including vaccinations use and suitability. And operating in such a highly regulated industry demands critical implications for quality and compliance to streamline the quality documents and SOPs across the organization, regardless of the geographical differences. Qualityze Document Management System supports all your quality management efforts by integrating document management solution with the existing processes, ensuring quick yet secure access to all the business-critical documents. Get Qualityze to manage all your critical documents on a centralized platform.

Change Management

Managing product and process changes are imperative for the biotechnology companies, but it requires well-defined evaluation criteria to deal with the upcoming changes. Only if you will take an integrated approach for change management, you tend to innovate at a faster pace while meeting regulatory and customer requirements. Qualityze Change Management Solution enables you to take that integrated approach. It allows you to define all the change management tasks, send notifications to your employees, and follow-up on the processes. This cloud-driven change management solution makes your organization adaptable to innovative changes.

Audit Management

Qualityze Audit Management System enables you to manage end-to-end audit lifecycle while offering enhanced visibility into your quality processes so that you can comply with the stringent quality standards. The heavily regulated industry like biotechnology needs powerful audit management software to get real-time visibility in their critical data, ensuring lesser risks of product failure. Qualityze Audit Management and Tracking Software allows you to plan, schedule, and prepare your audit checklist using the given templates to ease the entire audit processes without missing on any quality standards.

Training Management

If you want to create customized training courses that can make your workforce competent based on the regulatory standards, Qualityze Training Management Software is the perfect solution. It allows you to create relevant training programs and issue certificates on completion based on individual performance. You can also track the employees enrolled to send them alerts and notifications every time you need to announce something important related to their training sessions. Qualityze training management system enables you to keep your employees trained and focused.

Supplier Quality Management

As most of the processes depend upon the suppliers in almost all the industries, you must have a supplier quality management solution that enables you to streamline and optimize all the supplier-related tasks. Maintaining supplier relationships allows you to achieve excellence, especially in the vertical silos of your business. Qualityze Supplier Quality Management Solution ensures that you don’t miss on any good opportunities that a streamlined supply chain holds since it is more than sourcing and logistics nowadays. So, are you ready to manage quality right from the beginning?

Complaints Management

Managing customer complaints has become important more than ever for the leading biotech companies to centralize the complaints management system in order to lower the risks, comply with the industry best practices, and streamline the processes and operations. Qualityze Complaints Management Solutions enables you to document, manage, and keep a regular follow-up on the customer complaints, feedbacks, and queries. It also allows you to track the relevant actions. This cloud-driven solution allows seamless integration of complaints with other quality management processes and software including CRM and ERP.

Calibration Management

A biotech company needs to manage and record the equipment calibrations to achieve compliance. Qualityze Calibration Management Solution helps biotech companies to track the equipment inventory, schedule its calibration, and record all the performed calibrations. It supports E-signature for validation under 21CFR Part 11. Our solution help manages both internal and external calibrations efficiently so you can focus on other value-driving tasks. You can also control the calibration certificates and history records over a centrally accessible cloud platform, leveraging the flexibility and security it offers. Manage equipment calibrations with more conveniently than ever.

Maintenance Management

Qualityze Maintenance Management Software for biotech companies helps setting up compliant processes such as maintenance scheduling, spare parts management, inventory tracking, and more while meeting regulatory requirements. Our solution helps redefine documentation structure and configure workflows, based on your business requirements. In addition to efficient documentation and compliance, it helps you to track the inventory of spare parts. Every time the spare parts go below the threshold quantity, the process owners get notified. Most importantly, you can avoid production downtime by keeping the equipment well-maintained at regular intervals.

Why Choose Qualityze Enterprise Quality Management Solution for Biotechnology?

Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Biotechnology 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 Non-Conformance Management, CAPA Management, Document Management, Change Management, Training Management, Supplier Quality Management, Complaints Management, Calibration Management and Maintenance Management.