Quality Management Software for Biologics Industry

Qualityze Inc attends ISO 9001 and Audits World Conference, gains valuable insights on quality management and auditing!

Tampa, FL USA, 23rd March 2023: Qualityze is pleased to announce our recent participation in the ISO 9001 and Audits World Conference. The event took place on March 13-14, 2023 and brought together professionals around the globe to discuss quality management and auditing. The ISO 9001 and Audits World Conference is a premier event in […]

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 It is mainly due to disintegrated processes, disconnected data, outdated technology, and a longer change implementation cycle.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, Material Compliance Management, Forms Management, Permit Management, Training Management, Incident Management, EBR Management, Field Safety Action 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

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

Improved Business Processes

All the processes including complaints, nonconformances, audits, CAPA, supplier quality, and training get a little complicated in the blood and biologics companies due to intensive resources. And, most of these processes are managed at the department level, which increases the gap to quality. on the other hand, quality management software ensures that all the processes are standardized and managed at an organizational level, ensuring appropriate resource allocation and time management. A QMS eliminates the disparity to bring all the processes together in a closed-loop to improve the business processes continuously.

Culture of Continuous Improvement

Quality management software can improve visibility into business processes, enabling biologic companies to identify the areas of improvements at regular intervals. The same cannot be expected with a traditional quality management system. Maintaining the regularity in improvements can only be possible when your quality management system can be integrated with a powerful audit management system and CAPA process to keep a check on the consistency of product and process quality.

Improved Customer Satisfaction

Customer satisfaction is a very significant aspect of business success. In addition to the product quality, it is important to respond to your customer queries/feedback/complaints in a timely manner to ensure that they get what they expect. The manual processes and procedures may lack effectiveness and efficiency especially in the era of digitization where customers have multiple channels to express their dissatisfaction. Having a quality management system, however, ensures that you have regulated processes for handling and managing customer complaints in a professional and compliant manner while improving continually.

Increased Employee Engagement

The most common problem that every organization faces after implementing a change is resistance from the employees because they don’t get notified about it. They might feel the need for new training programs, tools, or systems that can make change implementation easier for them. Communicating with your team regularly, notifying them about change, introducing relevant training programs, are some of the activities can be streamlined and integrated using a robust quality management software.

Better Decision-Making Process

It is the quality of decisions that separated a good company from a great one. Relying on a paper-based document management system is not a sensible option in the world getting digital since data and information is growing enormously. A quality management software integrated with electronic document management systems, on the other hand, can help to store, analyze, and share data much more efficiently to improve the decision-making capabilities of the biologics companies. A quick analysis of available resources can help planning business operations, ensuring optimum utilization of the resources.

Enhanced Supplier Relationships

Maintaining a quality system in the blood and biologics companies require abundance of resources that may be supplied from different suppliers. It means supplier selection and supplier quality management are crucial for achieving product quality and customer satisfaction goals. A quality management software integrated with supplier quality management solution can help keep a track of supplier performance to ensure zero comprises of quality. when you help your suppliers to improve, you strengthen the business relationship and trust among each other.

How Does Qualityze Works for the Biologics Industry?

Qualityze EQMS is a perfect solution for blood and biologics company to establish, manage, and 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 16 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, and 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 16 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.

Permit Management Software for Biologics IndustryPermit Management

The person should have an approved and active license to export, import, and transport regulated materials such as biological products. However, keeping track of multiple licenses and their status can be challenging if you are doing business globally. Qualityze Permit Management for Biologics makes things simple and efficient. The software allows you to manage and track all licenses and permits renewals in one place. You can follow every detail from status to fees over a few clicks. Moreover, you can set the notification for renewal dates, so you get informed well in advance and do not miss the due date.

Material Compliance Management Software for Biologics IndustryMaterial Compliance Management

For the biologics industry to operate responsibly, suppliers must obtain materials from suppliers who do responsible sourcing from conflict-free mines in the DRC. In addition, the 3TG suppliers shall conduct adequate due diligence and verify the origin and origin of the raw materials used in the products. That is where Qualityze Material Compliance Management helps. In addition to sourcing from verified smelters and refiners that are conflict-free, it also helps them report their declarations on time. Using seamless integration, your suppliers can develop, implement, and document plans to deal with non-compliance in the supply chain on time. In addition, you can easily modify the pre-defined templates for CMRT forms and other regulatory declarations to meet changing business needs.

Forms Management Software for Biologics IndustryForms Management

The biologics industry captures more information than ever before, at a level and speed unlike any other. Despite the challenges associated with capturing and corralling data variance and complexity inherent to the industry, companies of all sizes face distinct challenges. Therefore, companies in the biologics sector can realize more significant benefits from applying technology solutions such as Qualityze Forms Management to manage these complex processes better and utilize the vast amounts of generated data. It provides a powerful, flexible, and adaptable solution for biologic companies for forms and data management, workflows, and computational analysis. You can easily configure forms as desired or create them from scratch because of the configurable workflows.

Field safety Management Software for Biologics IndustryField Safety Action Management

The FDA reviews recall information for biologics, advises the firm of the recall classification assigned, makes recommendations for changes in its recall strategy, and informs the firm that its recall will appear in the weekly FDA Enforcement Report. The company need not hold off on removing or correcting its products while this review is underway. It should instead streamline all the post-market surveillance and recall management activities. The simplest way out is using the Qualityze Field Safety Action Management solution. The software enables enterprises to analyze collected data and make intelligent decisions to prevent recalls. It is delivered on the most powerful and secure cloud platform, i.e. Salesforce.com. As a result, you can leverage greater flexibility, security, traceability, and reliability required to manage recall and FSCA details. It also has advanced in-built capabilities, including reporting, dashboards, audit trails, digital signature, and much more.

Incident Management Software for Biologics IndustryIncident Management

Biological medicines (biologics) require robust process and facility design, rigorous regulatory compliance, and well-trained personnel. Manufacturing biologic medicines include complex attributes and sensitivity to production and handling conditions that could result in incidents. And such incidents require immediate attention. Biologics manufacturers must have effective tools and policies in place to mitigate the cause of safety incidents to prevent their recurrence in the future. It is no longer feasible and efficient to use aging technology systems. An incident management system like Qualityze can ensure workplace safety and compliance while helping maintain workplace safety. Integrated with incident reporting, risk assessment, investigation, and root cause analysis, it provides businesses with every aspect of incident management. This intuitive software comes with centralized database to keep your incident records secure on cloud. See more about the product in the video.

EBR Management Software for Biologics IndustryEBR Management

Performing batch record reviews is essential to biologic operations since regulatory requirements and quality efforts demand this practice. Therefore, it would be best to document your firm’s production efforts. SOPs, process controls, and deviations all fall under batch control. The best way to avoid problems is to ensure you are clear, concise, and repeatable in your efforts. You can expect a litany of sanctions, recalls, and costly delays if your batch control documents are hard to read, sloppy, or – worse yet – absent. Since a robust batch record management and review system is essential for the manufacture of biologics, why leave anything up to chance? Get Qualityze Electronic Batch Record Management solution today. It ensures your efforts are efficient and compliant. From pre-defined templates to configurable workflows and intuitive interfaces, the software has all the amazing in-built capabilities an organization needs to achieve production excellence. 

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, Permit Management, Document Management, Change Management, Training Management, Audit Management, Supplier Quality Management, Customer Complaints Management, Incident Management, Field Safety Action Management, Material Compliance Management, EBR Management, Forms Management, Calibration Management, Maintenance Management and Inspection Management.