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 Software for Biologics Industry

For the biologics industry to evolve, the change will not be efficient. They would have to re-engineer their manufacturing processes wherein the FDA will have a major role to play. The main reason for modifying the product life cycle to eliminate inflexibility from the current processes that require preapprovals at different stages. Such a long and time-consuming process was keeping biologic companies from reopening and reviewing the product approvals. The companies didn’t realize the potential and need for implementing changes to keep the quality of products high. It’s high time that they upgrade to an advanced quality management solution that can help fill the gap while maintaining the quality and compliance standards high.

Qualityze EQMS is the next-generation QMS designed on the Salesforce.com platform that enables the Biologics companies to improve their process approach through real-time information analysis and regular audits. It helps organizations to ensure standardization throughout the organization to avoid any gaps even if the quality teams are at distant locations. This cloud-driven quality management solution ensures consistent service quality by allowing Biologics to follow the industry best practices defined as quality requirements under URS Certification that includes MHRA, AARP, BPCIA, and FDA Challenges USP Reference Standards for 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, 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 8 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 8 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

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

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 ManagementDocument 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

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

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

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

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

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

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 Non-Conformance Management, CAPA Management, Document Management, Change Management, Training Management, Supplier Quality Management, Customer Complaints Management, Calibration Management and Maintenance Management./p>