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 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, Complaint Management, Supplier 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
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 Planning & Decision-Making
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, 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:
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 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. It 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.
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 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.
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.
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.
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 Quality Management System for Biologics Industry?
Choosing Qualityze Quality Management System will be a beneficial decision for any Biologics Industry because it has:
- User-Friendly Interface : Our quality management software for Biologics industry comes with a user-friendly interface that doesn’t require you to be a technical expert to work with it.
- Configurable workflows and Fields : Our solution is highly flexible, and you can configure workflows and fields as per your company’s requirements.
- Seamless Integration : Our QMS can seamlessly integrate with the organizations’ existing system for enhanced functionality
- Low-Cost Implementation : With a cloud-based management solution like Qualityze, you need not worry about the implementation costs.
- Cloud-Based Platform : Qualityze QMS for Biologics industry is a cloud-based platform that ensures complete flexibility and safety for the data accessibility.
- Low Maintenance Cost : Our Quality Management software for Biologics Industry doesn’t have any specific hardware requirements. You can access it anywhere.
- Automated Upgrades : Automated upgrades can be made available with new releases as part of the subscription.
- Flexible and Secure : Our solution resides on world’s most powerful and secure cloud platform, Salesforce.com
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 Management, and Customer Complaints Management.