Qualityze Maintains the Tag of Innovation Leader with Three New Products Release

Qualityze Inc. ,The Innovation Leader in the World of Quality, launched three new products even in the challenging times of Pandemic. We believe “Every Challenge Opens the Door to New Opportunities.” And these tough times brought up the opportunity to extend our product range with three more products, namely, Calibration Management, Maintenance Management, and Inspection […]

Quality Management Software for Biologics Industry

Quality management in Biologics is quite challenging. It usually takes a lot of time and resources to deliver a batch of good quality products successfully. Even though the change appears crucial, the biologic companies are still hesitant to change their existing processes. A minor change in the existing processes can make a significant impact on overall productivity. It is mainly due to disintegrated processes, disconnected data, outdated technology, and a longer change implementation cycle. It would be best to have a powerful EQMS solution to streamline the business-critical data and processes. Qualityze EQMS is there to help you build a culture of quality and continual improvements. It will also foster better decision-making to implement changes more efficiently than ever.

Qualityze EQMS Suite is the next-generation EQMS for Biologics, designed on the Salesforce.com platform, to manage all quality and compliance-related challenges. It enables the Biologics companies to improve their process approach through real-time information analysis and regular audits. It helps them standardize their key processes to avoid gaps and maintain consistency even if the quality teams are at distant locations. With Qualityze intuitive interface, it becomes easier for Biologic companies to configure industry best practices workflows as defined under URS Certification, including MHRA, AARP, BPCIA, FDA, and USP Reference Standards Biologics.

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

Advantages of Quality Management Software for the Biologics Industry

Quality Management System for Biologics

Since quality management in biologics can be resource-extensive, using quality management software can be a perfect solution to manage functions of multiple areas of an organization including procedures update, supplier quality management, implementing advanced practices, and much more. The software also helps to align organizational processes with the regulatory standards to ensure operational and quality excellence. Here’s an overview of all the benefits that you can leverage with the integration of an end-to-end quality management software for the Biologics industry:

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

How Does Qualityze Works for the Biologics Industry?

Qualityze EQMS is a perfect solution for blood and biologics company to establish, manage, maintain an effective quality management system. It helps organizations to achieve excellence with compliance. It creates a closed-loop environment to drive continuous improvements. Built on the most powerful and secure platform Salesforce, the Qualityze EQMS suite encompasses 11 feature-packed modules to offer the Biologics industry unparalleled flexibility and scalability to expand and improve the quality quotient of their services in a simplified manner. Let’s have a look at how each module functions for the Biologics sector:

EQMS software for Biologics Industry

How Does Qualityze Works for the Biologics Industry?

Qualityze EQMS is a perfect solution for blood and biologics company to establish, manage, maintain an effective quality management system. It helps organizations to achieve excellence with compliance. It creates a closed-loop environment to drive continuous improvements. Built on the most powerful and secure platform Salesforce, the Qualityze EQMS suite encompasses 11 feature-packed modules to offer the Biologics industry unparalleled flexibility and scalability to expand and improve the quality quotient of their services in a simplified manner. Let’s have a look at how each module functions for the Biologics sector:

Nonconformance Management Software for Biologics IndustryNonconformance Management

Since FDA has mandated the documentation of the nonconformances to ensure every action plan made is justified and performed strategically, Qualityze Nonconformance Management Software is the solution that blood and biologic companies need. It leverages configurable workflows to capture information in a standardized format that everyone in the organization can understand and use accordingly. It also helps to perform an initial-level investigation of nonconformances identified to check if they require detailed investigation and CAPA.

CAPA Management Software for Biologics IndustryCAPA Management

CAPA process is one of the key operations in quality management since it helps to eliminate the root cause of the problems to prevent their recurrence in the future. Qualityze CAPA Management Software is designed to offer the biologics company a comprehensive solution to address the root cause of the problem by making a proactive approach. Qualityze corrective and preventive action software enables companies to use industry best practices and tools for root cause investigation so that they can implement appropriate action plans to resolve the problem permanently.

Document Management Software for Biologics IndustryDocument Management

Disconnected systems and paper-based documentation systems were literally killing the productivity of biologics. Qualityze Document Management Software is designed to give them added flexibility to improve their productivity. With the Qualityze solution, they can do more than just storing. Modifying, and sharing the critical documents; they can also collaborate and communicate with their quality teams regardless of their location to discuss the improvements required and make the important decisions together.

Change Management Software for Biologics IndustryChange Management

Change is the only constant – we all know that, but still, feel afraid of changes. This goes true for biologics as well. Managing quality is already a resource-intensive process for blood and biologics companies. And implementing changes to quality processes, policies, and procedures to meet industry and compliance standards is no less than a challenge for them. Qualityze Change Management Solution enables them to manage all such critical changes to the controlled documents easily while keeping every team member informed.

Audit Management Software for Biologics IndustryAudit Management

Audits are an excellent means of driving continuous improvements if conducted regularly. Qualityze Audit Management Software enables organizations to keep audit regularity maintained by allowing them to schedule audits in advance. It also comprises pre-defined audit checklists based on the compliance requirements that can be customized as per individual company needs. In addition to audits, you can also schedule their follow up in advance to keep a track of progress. It reduces audit cycle time while improving the process and product quality.

Training Management Software for Biologics IndustryTraining Management

Improving day-to-day productivity in biologics requires your employees to have an in-depth understanding of the biologic’s regulations, which comes from relevant training programs. Qualityze Training Management Software helps you create training programs and course profiles based on the roles and responsibilities that improve productivity as well as the competency of your employees. This cloud-driven training management solution enhances the visibility and traceability of employee training records to identify and eliminate the roadblocks. Qualityze training management solution is a perfect solution to match the flexibility that every modern employee and organization needs.

Supplier Quality Management Software for Biologics IndustrySupplier Quality Management

All the regulatory agencies for biologics assess the SQM program that helps them with supplier selection, raw materials quality checks, standard policies, and much more to ensure the highest quality and safety. Qualityze Supplier Quality Management Solution helps biologics companies to establish a standardized process for all the supplier activities from selection to quality check and switching to a new supplier for improved quality. It also enables organizations to strengthen supplier relationships by helping them improve their quality processes with regular feedback through supplier scorecards.

Complaints Management Software for Biologics IndustryComplaints Management

Managing the customer complaints mailbox and all related activities for biologic companies can become convenient with Qualityze Complaints Management Software. It helps you to follow a streamlined procedure that meets regulatory standards to achieve the goal of business excellence with continuous improvements. Every complaint received is a potential opportunity for any organization to attain customer satisfaction and trust with a timely response. And, Qualityze helps to gain that opportunity

Calibration Management Software for Biologics IndustryCalibration Management

Qualityze Calibration Management Solution for Biologics is designed to simplify periodic equipment calibrations. It helps you to create an asset library, set calibration schedules, manage standardized documentation, and perform validation through E-Signature to attain compliance with regulatory standards. It sends alerts and notifications to the calibration managers for out of tolerance reporting. It seamlessly integrates with non-conformance management and tracking software to report the equipment that cannot be calibrated and needs to be disposed of quickly to avoid any production delays. It improves traceability by keeping all the records on a centralized platform and fosters better decision-making.

Maintenance Management Software for Biologics IndustryMaintenance Management

The best practices for product consistency and compliance in biologics revolves around air quality, cleaning protocols, environmental controls, and data management. Qualityze Maintenance Management Solution helps biologic companies to manage all the mentioned aspects through effective maintenance of facilities and best-in-class reporting tool. It ensures that all the facilities are operating in compliance with the applicable regulatory standards, making maintenance a cost-effective option for asset management. Ours is a next-generation solution that helps biologics maintain quality outcomes and manage new challenges to attain sustained success.

Inspection Management Software for Biologics IndustryInspection Management

In the biologics industry, it is critical to have well-documented and streamlined procedures for investigating the product samples. It helps your quality teams to detect toxic contaminants in the products and minimize inconsistencies. Qualityze Inspection Management makes the biological products inspection simple. It enables organizations to customize their sampling plans and inspection standards in adherence to compliance requirements. You can generate nonconformance reports, evaluate the need for reinspection, and perform detailed investigations for the products or components that fail to meet the specification. In addition to streamlining the inspection processes, QIS automatically records the inspection-related data for analysis and informed decision-making.

Why Choose Qualityze Enterprise Quality Management Solution for Biologics Industry?

Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Biologics 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, Supplier Quality Management, Customer Complaints Management, Calibration Management, Maintenance Management and Inspection Management.