StartUs Insights Recognizes Qualityze Inspection Management Solution Among Top 5 Inspection Solutions for Process Industries

StartUs Insights recognized Qualityze Inspection Management Solution as the best tool to standardize, streamline, and automate the production operations to eliminate product quality and supplier risks in the initial stages. It is our commitment to quality and excellence that drives us to deliver more competent and innovative solutions. As a result, we enable organizations to […]

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 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, Inspection 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

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 11 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 Software for BiotechnologyNonconformance 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 Software for BiotechnologyCAPA 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 Management Software for BiotechnologyDocument 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.

Chnage Management Software for BiotechnologyChange 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.

Ausit Management Software for BiotechnologyAudit 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 Software for BiotechnologyTraining 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 Software for BiotechnologySupplier 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 Software for BiotechnologyComplaints 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 Software for BiotechnologyCalibration 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 Software for BiotechnologyMaintenance 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.

Inspection Management Software for Biotechnology IndustryInspection Management

In the Biotech industry, the inspections are mainly product-specific. It checks for the factors that can harm the protein or antibody stability. However, the stability of the biotechnology products is also sensitive to external conditions. It can be addressed with a thorough inspection process. And Qualityze Inspection Management is the best solution for such comprehensive inspection needs. It helps streamline, standardize, and simplify all the inspection-related processes to ensure the successful formulation of proteins. You can define the acceptable quality limits, sampling plans, inspection standards for a variety of products without any consistency issues. Qualityze Inspection Management can make your inspection processes smarter and efficient than before.

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 Nonconformance Management, CAPA Management, Document Management, Change Management, Training Management, Audit Management, Inspection Management, Supplier Quality Management, Customer Complaints Management, Calibration Management and Maintenance Management.