Qualityze serves the purpose of top QMS Software for pharmaceutical industry quite well. It comprises 18 different modules that help maintain the quality of drugs or medical equipment by following a well-defined world-class quality process. Let’s have a look at each module:
Qualityze Nonconformance Management Software for the pharmaceutical industry helps to document every product issue identified during the process of quality check in order to make right decisions at right time to maintain overall product quality. Also, any non-conformance issue needs to be a valid one for further proceedings.
Qualityze’s CAPA module helps your organization to proceed with right corrective and preventive actions for the non-conformance issues recorded. Only the valid non-conformances undergo the corrective and preventive measures whereas the invalid ones directly get terminated. However, the right measure at right time is all you need.
Qualityze’s Document Management system can help pharmaceutical companies to keep their critical documents maintained and verified to offer good information resources to the end-user or consumer. It can include information about the right dosage for different age groups, how to take the medicine, when to take it, and most importantly, how dangerous it can be an excessive amount. Our quality management software for Pharmaceuticals allows you to keep all such information documented that you can release with the product.
Qualityze’s Change management system is designed to help the pharmaceutical industry in maintaining the quality standards in adherence to the regulatory compliances. One can easily implement the improved practices in the system without staking the existing processes and workflows. Ours is a certified Pharmaceutical Quality Management System that makes your organization a change-ready organization.
Qualityze’s QMS for pharmaceutical industry also helps organizations to manage and control their audit operations. With our Audit Management System, your organization will have a managed flow of functions including creation, scheduling, preparation, execution, tracking, following-up their yearly, half-yearly, and quarterly audits accurately and timely.
Training has become an important part of today’s work life especially in the pharmaceutical industry so to keep employees versed with the machines used for the formulation of the drugs. With the Qualityze training management system, an organization can identify the training needs while keeping a track of sessions already completed by the employee including the certifications (if any).
Supplier Quality Management
With the increasing number of suppliers and competition in the market, supplier quality management has become one of the integral parts of quality management in any organization because of the supper quality, supplier risks, supplier analysis, and supplier selection process involved to make sure that only apt quality material and machinery is used for the drug formulation in compliance with standards.
Complaint handling is considered as Good Manufacturing Practice. And, the customer complaints management software of Qualityze helps pharmaceutical industries to maintain that. Our solution works as an opportunity to retain customer satisfaction while establishing a stronger relationship between company and customers by addressing their concerns on quality in a streamlined manner.
In the pharmaceutical industry, instrument calibration is a critical requirement to ensure product quality and safety. It also ensures compliance and reduces the costs that the company may bear due to inaccurate measurements and poor-quality products. Qualityze Calibration Management Solution enables pharmaceutical companies to maintain product quality and safety by efficiently scheduling and managing their calibration program. It also supports documentation and reporting to avoid any non-compliance with the applicable regulatory standards. Moreover, it improves the traceability of calibration records to ensure the product’s conformity, measurement accuracy, and production efficacy.
Whether it is corrective maintenance, preventive maintenance, predictive maintenance, or scheduled maintenance, Qualityze Maintenance Management Solution help streamline scheduling and standardize all the maintenance activities for the single site as well as multi-sites equipment. It provides a centralized database to store and retrieve the history records of equipment maintenance to improve accessibility and traceability while complying with FDA CFR Part 11. Our solution helps in effective planning and decision-making to adopt the best maintenance procedures and tools, based on the trends identified through advanced dashboards and reporting. It further minimizes downtime and increases the life of critical assets of pharmaceutical companies.
Inspection for the product content is vital for pharmaceuticals. Lack of content or the presence of wrong content can lead to catastrophic events. Qualityze Inspection Management enables organizations to prevent such events by streamlining their inspection processes while maintaining compliance. It allows them to set up sampling plans and inspection standards for each variety of drugs, minimizing the nonconformances and product recalls. It comes with an intuitive interface to make inspection management even more simplified and efficient for your quality teams. You can create nonconformance reports for the pharmaceutical contents and products that fail to meet the specified requirements. Also, you can evaluate the need for reinspection for certain materials, ensuring superior quality incoming materials for production.
Pharmaceutical companies can no longer continue using traditional tools or methodologies for managing the facility and individual licenses. It will only increase the costs and time consumption. Also, it’s not an efficient way to manage permits and licenses for businesses with a global presence. With Qualityze Permit Management Solution, pharmaceutical businesses can check the status of licenses for pharmacies and employees and take care of upcoming requirements on time. Our software’s tracking convenience and ease of use ensure your pharmaceutical facility stays compliant with appropriate licenses. In addition, through our intuitive permit management solution, you can eliminate wasting money, resources, and time on inefficient methods of obtaining permits, licenses, and other registration requirements for your pharmaceutical facility.
Material Compliance Management
In the Pharma industry, procurement from a verified and certified source has become mandatory. Qualityze Material Compliance Management makes sure that certified vendors are used when purchasing materials and keeps records for future references. In addition to maintaining supplier information, such as contact information, prices, and smelters associated with them, Qualityze also alerts companies when their declarations are due, ensuring compliance. The in-built capabilities of our solution help identify gaps and manage risks more proactively and efficiently than ever. It allows the organization to look holistically at strategic, operational, and other production activities. As a result, it can optimize decision-making and mitigate risks. In addition, by meeting compliance requirements across the entire supply chain, businesses can focus on boosting sales and improving operational flow.
Pharmaceutical research and drug discovery revolve around data. It provides departments, whether they are in clinical operations, pharmacovigilance, or analytics, with a single source of truth and makes transactional data more meaningful.
The key is to manage reference data centrally and ensure it is available to each team and system in the same form. It can be achieved using powerful forms management software like Qualityze. It provides a single repository for authoring internal data and managing forms. A centralized solution does more than save money; it also reduces the time wasted in sharing data between teams. As a final point, the solution enables data teams to create regulatory reports free of errors, which is of utmost importance because inconsistent data can cost a company its drug license.
Field Safety Action Management
In recent years, there has been an upswing in recalls of prescription medications and over-the-counter drugs. Most recalls are caused by discoveries made by the company, complaints from customers, or FDA observations. FDA reviews the firm’s recall strategy and could recommend changes as necessary. It contains details about the product, the failure summary, the amount of product produced in the distribution chain, and the direct account. Millions of products are recalled every year, affecting sales, customer relationships, and supply chains. You can significantly reduce the recall rate using Qualityze Field Safety Action Management. It enables enterprises to manage all their post-market surveillance activities efficiently. It allows you to manage regulatory reporting too. You can use the pre-defined templates to collect distribution data for different products in a consistent manner.
Whether it is a facility-related, storage-related, packaging or sampling-related, production related, or distribution related, every incident in the pharmaceutical industry must be reported timely. You can then proceed with the investigation and resolution of the root cause as per the SOP. Managing all the incident-related activities using legacy systems may require more time and efforts. But Qualityze Incident Management makes it a lot easier for you. This configurable software allows you to create different categories of the incidents so your teams can categorize and prioritize them efficiently. The software helps streamline all the incident related activities from reporting and investigation to resolution while ensuring compliance with OSHA and other applicable regulation. It seamlessly integrates with existing quality systems such as Document Management wherein you can manage all your policies and incident SOPs. Would you like to experience Qualityze difference in making incident management simpler?
Managing batch records efficiently in the pharmaceutical industry can help reduce medication shortages caused by production delays or quality control issues, resulting in medication shortages. They also help eliminate other problems during the manufacturing process, such as preventing contamination. In addition, the batch production record is used to verify that medication is manufactured following cGMP. Using paper-based systems will only make batch record management inefficient. It would be better to use Qualityze Electronic Batch Record Management Software. This cloud-driven software helps enterprises to create, manage, and track different types of batch records for every stage of production, from material inspection to packaging and safe shipping of the products. It has exceptional in-built capabilities such as Digital Signature, Audit Trail, Automated Approvals, Notifications, Pre-Defined Checklists, and much more to achieve compliance and operational excellence. Experience the Qualityze difference today by requesting a free demo.
Ultimately, we all want to ensure that medical devices are safe and effective. Due to this, risk management is a regulatory requirement everywhere. Medical device risk management begins early in the design process. Nevertheless, risk management processes extend beyond design and manufacture, including sterilization, packaging, labeling, storage, handling and transport, distribution, and market surveillance. The manufacturer must apply risk management from the product’s conception until its eventual decommissioning and disposal. It is, therefore, essential to gather post-production information. Qualityze makes the entire process simple and streamlined. You can configure the risk workflows per industry-proven best practices to minimize risks and improve operational efficiency. In addition, the system comes with an in-built risk matrix that allows you to evaluate risk severity and develop an action plan accordingly.