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 System for Nutraceuticals Industry
The nutraceuticals market is making an unprecedented growth with the increasing awareness of health and nutritious food concerns among customers. However, the quality of nutraceuticals is not controlled well. The need for quality management in nutraceuticals arises due to the chemical and biological components used in them. Though nutraceuticals are not covered by FDA like pharmaceuticals, they are regulated under a different set as “Dietary Supplements” by DSHEA i.e., Dietary Supplement, Health, and Education Act, and FDA takes complete responsibility for taking actions against any misbranded dietary supplement if it reaches to market. Therefore, companies require a formalized Quality Management Software for Nutraceuticals Industry to control the process and product quality, preventing severe health issues to consumers.
Cloud-based and compliance-driven, Qualityze EQMS is the next-generation quality solution for the Nutraceutical industry that enables organizations to establish and implement best practices to produce safe dietary supplements without fail. Built on the Salesforce platform, this flexible and robust quality management solution supports nutraceuticals manufacturers to fulfill unique requirements in R&D, inventory, costing, production, quality, product development, planning, scheduling, FDA traceability, FDA compliance, and warehousing.
The Qualityze EQMS software for Nutraceuticals Industry is a closed-loop quality system. It includes Document Management, Change Control Management, Nonconformance Management, CAPA Management, Permit Management, Audit Management, Training Management, Complaints Management, Field Safety Action Management, EBR Management, Calibration Management, Inspection Management, Material Compliance Management, Forms Management, Incident Management, Maintenance Management, Supplier Quality Management with exciting features like Audit Trail, Electronic Signature, Validations, Dashboards, Reports, and Analytics.
Advantages of Quality Management Software for Nutraceuticals Industry
Whether you want to produce vitamins and minerals, herbal blends, protein powders, or any other dietary supplements, implementing a robust quality management software can help streamline your processes to ensure delivery of safe and edible nutraceutical supplies to promote healthy lifestyles. A Nutraceuticals QMS Software streamlines the entire workflow for consistent quality while meeting the stringent FDA mandates. Here’s an overview of all the benefits that you can leverage with the integration of an end-to-end quality management system for Nutraceuticals industry:
- Improved Business Processes
- Simplified Documentation
- Improved Customer Safety
- Increased Employee Engagement
- Better Planning & Decision-Making
- Improved Supplier Relationships
Improved Business Processes
Nutraceuticals are expected to keep track of their processes and improve continuously to meet compliance with the regulatory standards. A robust QMS software for Nutraceuticals helps them build a closed-loop system of processes to drive a culture of continuous improvements and quality. From labeling to the bill of materials and quality testing to distribution, you can manage every single process while remaining compliant with stringent requirements. Additionally, a quality management system helps nutraceutical companies to act responsibly towards environmental factors by assisting them in performing validation of storage and processing units at regular intervals.
Nutraceuticals need a robust system to manage and process their quality data within time. Implementing best practices, precise classification of data, recording, and traceability requires nutraceuticals to maintain their records’ accuracy. It further helps them make evidence-based decisions that are likely to improve business performance. Besides, nutraceutical companies do need precise data to demonstrate the conformance of the product for safe consumption. Nutraceuticals Quality management software integrated with the document management system help process all the critical nutraceutical information efficiently, accurately, and timely.
Improved Customer Safety
Customer safety and compliance are some of the major concerns of many nutraceutical companies. An all-inclusive quality management software help nutraceutical companies to manage customer issues, investigate, and trigger critical processes like CAPA and audits efficiently. It enables them to put precise controls in place on time to avoid risks to customers. A quality management software also improves the visibility and reporting that allows nutraceutical companies to take a proactive approach in mitigating potential causes before they cause any harm. Therefore, a Nutraceutical QMS helps make a holistic approach to quality to ensure customer safety.
Increased Employee Engagement
Employee engagement is a concerning issue for many companies in the nutraceutical industry. Whether it is job-based training or performance evaluation, an organization needs to take adequate measures to foster employee engagement. Nutraceutical Quality management software can help organizations fulfill the training requirements, change requirements, improve communication, and review other potential factors that may restrict your employees’ performance. A QMS help build a culture of continuous improvement that positively influences employee engagement, regardless of their number and job function. When an organization invests in employees, it experiences real growth and development in return.
Better Planning & Decision-Making
Planning and decision making are necessary elements of a business strategy. Without considerable thought on the planning of the resources that must be available for quality teams, reviewers, and sponsors, implementing the quality system in nutraceuticals may not give desired results. A quality management software facilitates detailed analysis and reporting to understand the behavior of trends that help nutraceutical companies to plan and decide accordingly. It helps reducing resource wastage, take preventive measures, and manage all types of quality issues before they lead to any harmful consequences. A Nutraceutical QMS Software makes your best companion plan and makes business decisions.
Improved Supplier Relationships
Another big challenge that nutraceutical companies face is supplier quality management. Maintaining supplier relationships in the ever-growing supply chain is difficult since a large volume of suppliers and vendors are included for a variety of ingredients. Nutraceutical companies require a scalable and robust system in place that allows them to collaborate with all the suppliers and vendors, ensuring good manufacturing practices are religiously followed. Also, the right quality system enables companies to ensure that they are sourcing the ingredients as well as suppliers correctly, based on the selection and performance evaluation metrics.
How Does Qualityze Works for Nutraceuticals Industry?
Qualityze EQMS Suite is a set of smarter quality solutions designed to serve the nutraceutical industry’s quality management needs. Configurable workflows and user-friendly interface make the software easily adaptable for all size of companies to achieve operational excellence. Built on the Salesforce platform, Qualityze enables companies to manage their quality data flexibly and securely. Let’s have a look at how each module functions for the Nutraceutical industry:
In nutraceuticals, there could be numerous reasons for nonconformances, such as lack of a quality culture, no proper maintenance of systems, ineffective implementation, and much more. Qualityze Nonconformance Management System for Nutraceuticals is a single solution to all your worries regarding product and process quality. It helps your quality teams build a closed-loop system that drives continuous improvements and fosters a culture of excellence. It further helps to reduce operational risks and increasing conformance to the specifications defined and regulatory requirements. To put simple, Qualityze strengthens the quality culture in nutraceutical companies.
Qualityze CAPA Management Software for nutraceuticals is meticulously designed to manage the investigation and risk assessment challenges. It enables organizations to have compliant CAPA procedures for improved production and process control while demonstrating adherence to standard guidelines. With Qualityze, organizations can keep all their records documented that can be analyzed at regular intervals to take preventive measures against potential nonconformances and eliminate risks. If, in any case, the precautionary measures don’t work as intended, the corrective action part of our solution helps you address the nonconformance that occurred in a standardized and compliant manner.
For every nutraceutical product, you must maintain certain technical documents such as unit formula, batch formula, manufacturing process, control procedures for raw materials and finished products, specifications, certificates, details of storage conditions, packaging materials, labeling parameters, and more. Qualityze Document Management Software enables nutraceutical companies to manage all such critical documents on a centralized database, making it instantly accessible by quality teams from anywhere around the globe. Our solution supports eSignature to ensure verified access to documents, primarily if it is meant for a specific group of people.
Irrespective of the fact that the change is the only constant, many industries, including nutraceuticals, fail to manage the organizational changes. Qualityze Change Management Software helps nutraceutical companies establish a standardized change management process that increases organizational efficiency and keeps employees informed and involved in active change processes. Having a comprehensive approach to change management can help your company improve and grow stronger against the marketplace’s emerging challenges. Our robust solution keeps your organization ready for all types of changes – process, document, procedures, and more – while maintaining compliance.
As per defined specifications and guidelines, the nutraceutical manufacturers are responsible for adhering to good manufacturing practices to deliver safe dietary supplements. But they are not restricted by FDA approval before selling a product. However, they are required to notify about the product ingredients to FDA along with the evidence of ingredients safety. It becomes even more critical for nutraceuticals to perform audits regularly and keep track of quality events such as deviations, non-conformances, out-of-specification reports, corrective actions and complaints, and more. That’s where Qualityze Audit Management Software for Nutraceuticals plays a vital role. It enables nutraceutical companies to manage end-to-end audit process cycles and meeting compliance.
Training is imperative to maintain the highest standards of quality and compliance by following good manufacturing practices (GMPs). As per the GMP regulations, employees involved in manufacturing, packaging, labeling, and holding of dietary supplements must be trained in their respective roles to maintain compliance with 21 CFR 111. Qualityze Training Management Software solution enables nutraceutical companies to align their training programs with industry-specific compliance regulations. Nutraceutical Training Management System helps create training programs, based on job-functions, departments, and roles to make your employees more competent and productive. Are you ready to take a comprehensive approach to training?
Supplier Quality Management
In the nutraceutical industry, the supply chain is getting more complicated due to the rise in emerging markets and scarcity of resources. The concern for quality to choose the ingredients supplier is even intense. But, Qualityze Supplier Quality Management System for Nutraceuticals streamlines the supplier selection and performance management process efficiently for nutraceutical manufacturers. It allows them to define supplier selection criteria, performance metrics, and other evaluation criteria to sort their approved supplier list and consistently deliver quality products to the market. Our solution comes with a pre-defined supplier questionnaire that you can configure, based on your business requirements, for a simplified supplier selection process.
Customer Complaints Management
Qualityze Complaints Management Software for Nutraceuticals enables manufacturers to respond faster to product issues raised internally or externally. It standardizes the complaints process wherein you can perform the investigation, risk assessment, and detailed analysis to provide the most relevant resolution. Such a systematic approach to customer complaints management system help nutraceutical companies to improve their quality management system and controls. You can also leverage the transparency, audit trail, and reporting to manage complaints records in compliance with applicable regulatory standards.
As we have already discussed above, nutraceutical manufacturers are responsible for the safety of dietary supplements before they are marketed, as per DSHEA. They need to document all the adverse events, including temperature or humidity excursions, validation studies, mapping studies, in a tamper-proof manner for timely equipment calibrations. That’s where Qualityze Calibration Management Software for Nutraceuticals does the trick. It helps nutraceutical companies to manage their equipment calibration schedules on required intervals while keeping all the records documented on a centralized platform. Further, the calibration records work as evidence in the regulatory inspections to demonstrate compliance with standard measuring values.
Just like pharmaceuticals, nutraceuticals also need to maintain the equipment health from time-to-time with regular maintenance. It could be corrective maintenance, preventive maintenance, or predictive maintenance. Qualityze Maintenance Management Software for Nutraceuticals helps nutraceutical companies manage the scheduled and unscheduled maintenance programs of critical equipment to ensure longer life and lower production downtime. A maintenance management system helps in controlling costs and unnecessary delays; it helps in ensuring efficient manufacturing processes.
It is necessary for manufacturers of nutraceuticals to satisfy safety regulations with regards to the ingredients and products they are preparing by inspecting their safety and potency. Qualityze Inspection Management solution enables nutraceutical manufacturers to streamline their inspection processes while meeting compliance. It allows them to establish the inspection standards for different types of nutraceutical products, including tablets, capsules, teas, soft gels, and much more, to test their quality and safety before distribution. You can immediately generate non-conformance reports for the supplements that fail to meet the defined requirements and implement a suitable action plan. You can also schedule the reinspection for the materials having low variability in their characteristics to avoid unnecessary rework or wastage.
You need specific licenses to sell and distribute nutraceuticals like any other industry. However, FDA regulates the sale of dietary supplements. Therefore, you need to follow all the best practices for quality and compliance. For this, you can implement a comprehensive EQMS that supports permit and license tracking solutions like Qualityze. It is an integrated solution that streamlines and simplifies processes to achieve excellence in quality, safety, and compliance. Our permit tracker helps you stay ahead of renewal due dates to avoid compliance issues and penalties. It is suitable for single- and multi-site operations to manage all the relevant permits and licenses in one place.
Material Compliance Management
A nutraceutical company needs to ensure that its annual reporting requirement covers all sources of conflict minerals within its entire supply chain to perform proper due diligence. However, it becomes quite burdensome for companies to cascade these reporting requirements down through the tiers of their supply chain, which may consist of many tiers while securing data from multiple departments inside those tiers. As a result, new types of supply chain challenges are emerging. You can mitigate all such challenges using Qualityze Material Compliance Management Solutions. It helps organizations perform all the due diligence activities in a timely and compliant manner. In addition, it comes with pre-defined CMRT forms to make the process even more efficient. Experience the Qualityze Difference today.
Quality analysts in the Nutraceutical industry rely on quality data for analysis and decision-making processes. And the best way to acquire data is through forms that enable enterprises to capture valuable information from customers and stakeholders. How you manage forms can make or break your business growth opportunities since it contains insightful data. That’s where Qualityze Forms Management comes to the rescue. It enables nutraceutical companies to manage different forms without impacting employee productivity. You can create forms for every process, from purchase orders to work instructions, by configuring the pre-defined templates to your business and compliance needs. It is integrated with digital signature capability to fulfill your form validation needs. It has plenty of impressive in-built capabilities such as notifications and alerts, email approvals, audit trail, and much more to significantly reduce the form management process cycle.
Field Safety Action Management
Dietary supplements that have been proven to help prevent or cure disease are at the forefront of this battle. The “nutraceuticals” represent a significant opportunity for pharmaceutical companies to deliver consumer-focused, affordable solutions to issues that are currently solved by pharmaceutical intervention or not at all. That’s where Qualityze helps. It enables nutraceutical companies to proactively manage their recalls while sending timely reports to regulatory bodies. In addition, it helps unlock more opportunities by leveraging enterprises all the cloud benefits. The software lets organizations reduce the process cycle time with pre-defined templates and configurable workflows. The audit trail functionality of the system allows users or regulatory bodies to track every detail regarding the recalls, including their nature and communication plan.
To report a severe reaction or illness caused by a dietary supplement, you must immediately stop using the product and submit your complaint to the nutraceutical company. They would further report the incident and take appropriate action to resolve it. The entire process is referred to as the incident management and reporting process. With the increasing use of nutraceuticals, it has become even more critical to keep track of incidents and resolve them at the earliest. That’s where Qualityze Incident Management helps. It streamlines the process of incident management and provides pre-defined templates for accelerating incident reporting. The impressive in-built capabilities, configurable workflows, and intuitive interface completely transform the way you used to manage incidents and their causes.
Today, more and more people are becoming health-conscious and looking for the latest supplements to improve their lifestyle, so Qualityze Electronic Batch Record Management Software offers nutraceutical manufacturing solutions that will streamline production processes and comply with increasingly stringent FDA regulatory requirements to help you launch new products more quickly. The software supports your unique needs of batch records management for producing your line of protein powders, vitamins and minerals, dietary and herbal blends, or sports and wellness supplements. It comes with pre-defined templates for quality control checklists, production checklists, inspection checklists, shipping checklists, and much more to reduce the administrative workload of your quality managers. The software supports digital signatures for data validation at every step. It has impressive in-built capabilities such as Audit Trail, Centralized Database, Email Approval, Notifications, Dashboards, and much more to improve the batch record management experience.
Why Choose Qualityze Quality Management System for Nutraceutical Industry?
Choosing Qualityze Quality Management System will be a beneficial decision for the Nutraceutical industry because it has:
Qualityze EQMS for Nutraceuticals Industry offers a lot of value to any organization with its customizable cloud-based software for Nonconformance Management, CAPA Management, Document Management, Change Control Management, Audit Management, Training Management, Field Safety Action Management, Permit Management, Supplier Quality Management, Material Compliance Management, EBR Management, Forms Management, Incident Management, Customer Complaints Management, Calibration Management, Inspection Management and Maintenance Management.
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