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 18 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:
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.
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.
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.
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.
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.
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
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?
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.
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.
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.
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.
In the Biotechnology industry, all activities associated with the introduction, excluding post-harvest monitoring by volunteers, must take place on or after the active date and before the permit expires. If the permit renewal is missed, it could hinder the overall operations. But not anymore. Get Qualityze Permit Management to manage permit and license renewals on time to avoid last-minute rush and late penalties. It allows you to set alerts, track fees and yearly maintenance charges, and much more. Moreover, you can track the permit and license renewal-related activities for annual auditing. The intuitive interface and dashboard make it even easier for you to track details regarding their individual and facility permits on a centralized platform.
Material Compliance Management
Whether you are manufacturing active biotechnological substances or providing biotechnology manufacturing services to other companies, you must verify the source of minerals to ensure compliance. To maintain a conflict-free supply chain, all businesses involved in manufacturing and sourcing must ensure their smelters are conflict-free. It can be challenging to balance the business needs and the risk of noncompliance. But, you can rely on Qualityze Material Compliance Management for biotechnology. It is an integrated solution to help enterprises track all their supplier-related information in one place. You can maintain audit trails for your suppliers as well as their sources. It comes with pre-defined declaration forms, audit checklists, and much more to significantly reduce process cycle time. Our solution is configurable and intuitive, so you and your suppliers can manage all compliance-related activities without any hassles.
In biotechnology, data has become one of the essential tools. However, many biotech researchers struggle with time constraints and may not achieve their desired results for several years. Nonetheless, data analysis tools allow for the availability of these results much faster since the source of error can be identified and corrected more quickly. One such tool is Qualityze Forms Management. It enables companies to create different types of forms to capture insightful data. You can then analyze the data to provide the most accurate information necessary to meet business objectives. Furthermore, companies can also use it to comprehend their markets better and apply the most suitable solutions according to the situation. With Qualityze, you can easily modify the forms as per the changing business and regulatory requirements. It ensures that you collect the most appropriate data always.
Field Safety Action Management
Like every other industry, biotech performs detailed analysis to assess product performance and ensure safety of their products and processes. If any issue or risk is identified post the market release of the product, the quality teams take appropriate actions to address issues. The same process is applicable to the customer complaints. In addition to all, there is documentation and regulatory reporting to manage to ensure compliance. The traditional paper-based systems may add complexity and delays to the overall operations. It would be best to implement a powerful Field Safety Action Management solution like Qualityze. It enables enterprises to reinforce best-practices for managing product recalls to ensure safety and compliance. It automatically stores all the FSCA details including nature of recall, scope, task owner, distribution data, and more on a centralized platform. Most importantly, regulator reporting becomes a matter of few click with this advanced software.
Even after drastic improvements, the Biotechnology industry still lacks mechanisms to manage incidents that may happen during experiments. Biotech companies must implement the right incident management and reporting tools to support them in making the most of biotechnology advances while mitigating its downsides and risks. And the most reliable tool for Biotechnology is Qualityze Incident Management. With this intuitive and configurable solution, you can create different categories of incidents suitable for your business to ease the categorization and prioritization of the incidents and near-miss events. It also helps perform detailed analysis and investigation to identify the incident’s root cause. Then, you can take appropriate actions to mitigate the root causes and prevent similar incidents in the future. Qualityze presents biotech with a simplified way to manage incidents.
The pressure on biotechnology companies to develop new drugs quickly has never been greater. As a result, many of these companies are reevaluating their manufacturing strategies to ensure each batch leaves the plant on time and safely. This comes with a bigger responsibility of managing batch record data. Therefore, it would be best to implement a powerful electronic batch record management solution like Qualityze. It enables enterprises to standardize batch record management processes with configurable workflows. Learning and using this software is simple due to its intuitive interface. Using the pre-defined templates, you can create the required QC checklist, bill of materials, and other batch production records. In addition, the software supports digital signature validation, so you can always comply with FDA Part 11 and other best practices. Experience the simplest way of managing and tracking batch production records with Qualityze.
Biotechnology is associated with unique risks because it relies heavily on research, requires a specialized environment to develop scientific breakthroughs, and has tangible and intangible costs. In addition, a risk profile should consider the business’s reputation, ethical concerns, cultural concerns, and even religious concerns. Risk management is complex in the biotechnology industry because costs take a long time to return. To mitigate this risk, it is necessary to align the risk management plan with the quality goals. Qualityze Risk Management makes the entire process simpler. It helps risk managers to configure the best-practices workflow to manage risks and maintain organizational excellence. It simplifies risk documentation and compliance with its advanced capabilities, such as reporting and analytics, dashboards, notifications, alerts, and digital signatures. With Qualityze, experience the most innovative way of managing risks.