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 Lifesciences
Quality is at the heart of the highly regulated Lifesciences industry. Ever changing regulations and technology are improving the quality of life, though often increasing the complexity of managing business processes. The Quality System requirement for this industry is very stringent. To maintain a robust, flexible and compliant integrated quality management system for lifesciences, quality issues need to be tracked, managed proactively and resolved quickly. Qualityze, the next generation quality management software for Lifesciences is built on the Salesforce.com platform. A cutting-edge enterprise cloud platform with flexibility, ease of use, risk mitigation and compliance enabled. The solution provides you with a closed loop EQMS system that enables you to be compliant with internal and external regulations. Qualityze enables you to comply with US FDA (21 CFR part 11, 21 CFR part 820), ISO 13485 standards, Pharmaceuticals and Medical Devices Agency (PMDA), and Therapeutic Goods Administration (TGA).
The Qualityze EQMS software for lifesciences is a closed-loop quality system which includes Document Management, Change Management, Nonconformance Management, CAPA Management, Audit Management, Field Safety Action Management, Training Management, Material Compliance Management, Forms Management, EBR Management, Complaints Management, Supplier Quality Management, Inspection Management, Incident Management, Permit Management, Calibration Management and Maintenance Management with exciting features like Audit Trail, Electronic Signature, Validations, Dashboards, Reports, and Analytics.
Advantages of a Quality Management Software for Lifesciences
The selection of the right life sciences quality management system (QMS) is essential to maintain your organization’s sustainability. It enables you to deliver quality products timely while complying with all the applicable regulatory standards.
The integration of an end-to-end quality management software for lifesciences helps to leverage numerous advantages including:
- Better Control
- Compliance with Industry Standards
- Consistent Production
- Improved Product Assessment
- Improved Internal Communication
- Supplier Management
Highly regulated industries like lifesciences treat metrics as their success factors. Maintaining a balance of metrics is significantly important. In addition to that, there is a need to manage the operational risks, internal and external processes, and regulatory compliance while keeping quality a superiority. All these functions can be handled well through a lifesciences quality management software system, which is built to stand firm against the test of time and quality.
Improved Product Assessment
With the ever-growing customer expectations in terms of quality, there is a need of continuous improvement in the practices and processes followed by an organization to enhance product quality especially in the highly regulated industries like lifesciences wherein regulatory compliance like FDA makes an important factor in success evaluation. Only a configurable quality management system can serve the purpose while allowing organizations to configure the product assessment processes with the time.
Compliance with Industry Standards
To help organizations to cope up with the changing terms and conditions of regulatory authorities and attain the specified level of quality, there is a need of a well-structured Enterprise Quality Management System (EQMS) that brings together Quality, Collaboration, Compliance, as well as the Social capabilities. The best way that lifesciences can face the growing complexities of compliance and business models is through a quality management system that works for them.
Improved Internal Communication
A lifesciences quality management system boosts the internal communication in an organization by creating a centralized system to manage their processes. The automation of processes like scheduling a review, follow-up, corrective action etc. eliminates the loopholes of the traditional communication system wherein there are high chances of miscommunication, or delayed information that eventually affects the product quality delivered. It will not be wrong to say that a new generation quality management system can make the communication in an organization smooth and transparent.
Once you have identified the right way of attaining product quality, it’s wise to stick to that. This helps reducing cost, time, efforts for redoing the things from scratch. You can automate the process once and put things on repetition, as specified under ISO guidelines as well. Consistency and repeatability go hand-in-hand. With automated quality management system, this becomes even more feasible while giving organizations enough flexibility to deal with the upcoming challenges on the way.
Supplier quality is one of the most prominent yet overlooked aspects of a quality management process. Every organization dealing in lifesciences has an association with some vendors and suppliers to get the required material from. Managing the interaction with them while keeping a track of change or action requests made in a streamlined manner can be easily done with the help of an efficient and effective quality management system that can help to maintain a quality relationship with the supplier while keeping the process and product quality adheres to compliances.
How Does Qualityze Works for Lifesciences?
Qualityze is a fully configurable QMS Software for Lifesciences that helps to standardize the processes and workflows to meet the quality specification highlighted by the regulatory compliances, ensuring customer satisfaction. With 18 different modules, Qualityze is an EQMS suite that deals with complex Lifesciences quality instructions in a simplified manner. Let’s have a look at how each module functions for the Lifesciences:
How Does Qualityze Works for Lifesciences?
Qualityze is a fully configurable QMS Software for Lifesciences that helps to standardize the processes and workflows to meet the quality specification highlighted by the regulatory compliances, ensuring customer satisfaction. With 16 different modules, Qualityze is an EQMS suite that deals with complex Lifesciences quality instructions in a simplified manner. Let’s have a look at how each module functions for the Lifesciences:
Qualityze Nonconformance Management Software for Lifesciences helps to identify the critical problems that may later evolve as bigger trouble to the organization as well as the customers. We understand that it’s a challenge for the organizations dealing in medical devices and drugs industry. Our solution evaluates the quality of products as per the new requirements specified by the regulatory compliances as well as the organizations to not to leave a single issue unattended. You can also document and evaluate the risks involved to get in the right direction.
With the configurable Qualityze CAPA Management Software solution for Lifesciences , you can tweak out the root cause of the problems encountered as non-conformance by performing an in-depth analysis even it meant to be through different departments of the organization. The objective it serves is treating the root cause of the problem to avoid its reoccurrence in the near future. The user-friendly interface of our software makes it easy for a user to define action plans in a systematic order, handle review and approvals, implement the action plan, and verify the same. Ours is an integrable solution that you can link to other systems and processes for improved decision making and productivity.
With Qualityze Document management Software for Lifesciences, an organization can experience utmost ease with document management and control processes. Our solution helps with the creation, categorization, review, approvals, release, security, collaboration, and many more functions involved in the document control and management. Comprising a user-friendly interface, our document management solution makes it easy for every user to operate it without any extensive technical training. You can simply create a central repository that can be accessed by everyone from the desired location at the desired time.
Qualityze Change management software for Lifesciences is designed to encourage organizations to follow the best practices and to keep the entire change lifecycle smooth and convenient for the workforce. Our solution supports every aspect of change management including initiation, review, approval, execution, verification and validation, and final closure. In addition to all this, Qualityze change management system is easy to integrate with the existing quality management processes and systems in an organization.
To enable businesses to remain compliant irrespective of the complexities especially for highly regulated Lifesciences, Qualityze Audit Management System is the best solution to opt. Our solution is flexible enough to support different types of the audits conducted in any organization to ensure quality processes, products, and services including internal, external, operational, suppliers, IT , and quality audits. Through this efficient system, you can easily manage the entire audit lifecycle from planning to scheduling, defining the standards to preparing checklists, conducting to analyzing audits, tracking the findings and risks to final reporting.
Any organization’s effectiveness cannot be boosted without keeping their workforce trained and enabled for the processes and workflows followed in an organization. Qualityze training management system for Lifesciences is designed considering the need for effective training sessions in an organization. Our software helps the organization to manage the training sessions for different personnel with different job functions with the required courses and training documents. And, Qualityze TMS allows easy integration with the existing systems and processes too.
Supplier Quality Management
Qualityze supplier quality management software solution is designed on a cloud-based platform with an easy-to-comprehend interface to offer utmost ease, convenience, and accuracy in the supplier related processes to ensure quality right from the beginning. Our supplier quality management system complies well with different internal as well as external regulatory standards so that only quality products are supplied. Also, you can keep a track of entire supplier data while enhancing collaboration and communication with them.
Qualityze Complaint Management System is designed to allow the organization to have a loyal customer base by listening and responding to their complaints. Our solution defines a systematic order to track and manage every customer’s feedback in order to ensure that those problems didn’t occur repeatedly especially if the issues identified requires corrective action. With this effective system, you can track every complaint’s lifecycle from documentation to initiation, investigation to reporting till its final closure to ensure that no further loopholes exist.
Calibration management is crucial for a highly regulated industry like Lifesciences. Qualityze Calibration Management Solution enables Lifesciences companies to reduce the administration efforts on calibration activities by helping them to schedule the equipment calibrations. It also reduces the operational costs, and keeps the Lifesciences companies audit-ready, complying with the regulatory requirements. It requires no additional efforts for documentation and saves time with streamlined workflows. It instantly sends alerts for unscheduled calibrations. Therefore, Qualityze manages all your calibration schedules efficiently to ensure compliance, quality, and excellence.
Qualityze Maintenance Management Software helps in preventive maintenance scheduling and asset management while reducing business operational costs and ensuring compliance with applicable industry regulations. Our solution also helps in maintenance documentation for FDA 21 CFR11 compliance. Leveraging a smarter quality solution like Qualityze can help you gain a competitive advantage. It provides detailed insights of historical records to schedule and executes equipment maintenance at required intervals of time. Moreover, it seamlessly integrates with existing quality systems to maintain the health of your critical assets, business processes, and strategies in a single environment.
FDA has specifically categorized inspections for the highly regulated industries, including Lifesciences, to ensure product quality and safety. Whether you want to streamline routine inspections, pre-approval inspections, compliance follow-up inspections, and for-cause inspections, Qualityze Inspection Management for Lifesciences is a reliable solution for you. It enables organizations to set up sampling plans, inspection standards, inspection types, and purchase orders in adherence to the applicable regulatory standards. It offers you better control of product quality, safety, and reliability. The advanced reporting and audit trail functionality integrated into QIS gives you complete insights on the inspections performed so your quality inspectors can plan for future or follow-up inspections accordingly.
Fulfilling the licensing requirements of the Lifesciences industry is fundamental to keeping your business operating in a state. Having an updated license will allow you to enter new markets, open new facilities, hire staff, and obtain financing. On the other hand, license violations may lead to state-imposed penalties or delinquencies, preventing your business from growing. But Qualityze Permit Management saves you from all such violations. It enables you to manage, monitor, and track all types of licenses and permits effortlessly and efficiently. The solution comes with an intuitive dashboard and interface, so you and your team require minimal technical training to use it regularly. The best feature of the solution is the notification that keeps your teams informed about due renewals.
Material Compliance Management
Regulation compliance is a demanding requirement for the life sciences industry. It can be exhausting to stay current on CAP, ISO, and HIPAA regulations. Non-compliant processes can result in fines and reputational damage, and inefficient processes waste time. Implementing an enterprise-wide compliance solution like Qualityze Material Compliance Management ensures adherence to policies, proper risk management, and understanding of critical issues. In addition, organizations can address issues before they become compliance risks by giving suppliers a platform to report several declarations regarding the use of conflict minerals. By automating compliance systems, organizations reduce the cost of regulatory compliance, streamline processes, and demonstrate their commitment to ethics and a culture of quality.
For highly regulated industries such as Lifesciences, structured data must be collected on administrative, institutional, and clinical forms, regardless of device and location. Because form data is so valuable, it’s time for companies to understand how forms can impact their informational models and boost their staff productivity, rather than considering them as just a cost of doing business. It’s not an expense to fear; it’s an investment in improved data – a digital asset that’s already valuable but will only become more so over time. So, you should implement Qualityze Forms Management to capture quality data efficiently. In addition, it has integration capabilities to integrate forms and EHR. With our solution, you can achieve another data collection and connectivity level that paper-based forms and most EHRs just can’t provide. The risk is that if you wait too long, you might miss out on exciting growth opportunities all along.
Field Safety Action Management
Taking preventative measures to mitigate quality issues can help reduce or eliminate the need for recalls rather than reacting to them in the aftermath. Organizations that control their quality systems reduce recalls and quality problems. The best way to control and prevent recalls is to implement a Field Safety Action Management system like Qualityze that includes proactive risk management tools. Qualityze Field Safety Action Management is a fully featured tool to manage all your post-market surveillance activities from one place. The solution comes with pre-defined distribution data templates that you can configure to your growing business requirements. In addition, the software simplifies regulatory reporting with an intuitive interface and robust reporting tools. Furthermore, you can significantly improve decision-making processes with the increased traceability that the software offers. Lastly, you can use the audit trail functionality to keep a check on activities conducted with all the relevant details in one place.
To ensure success, the life sciences industry relies heavily on workplace safety, employee wellbeing, and patient safety. It includes medical device companies, pharmaceutical companies, biotechnology companies, and healthcare firms. In addition, these sectors are very regulated, so health & safety leaders must follow OSHA and other safety compliance requirements. LifeSciences companies should also plan safety precautions against hazardous chemicals, biological hazards, etc., and general workplace safety guidelines. Aging technology systems are no longer reliable and efficient for the purpose. They need comprehensive incident management software like Qualityze that helps maintain workplace safety while ensuring compliance. It is an integrated solution that helps businesses in every aspect of incident management, including incident reporting, risk assessment, investigation, root cause analysis, and resolution.
The adoption of EBR can help Lifesciences companies improve product quality and process efficiency by eliminating paperwork, distributing information quickly, and facilitating strategic planning. Managing batches of Lifesciences records electronically can also reduce print, store, review, and retrieval costs. However, implementing new technology may be challenging for employees comfortable with the tried and true old way of doing things. As a result, they may try to slow down or stall the adoption of EBR. This means you need a user-friendly EBR solution that your employees can use without hassles. And Qualityze is the one you can rely on. It is a configurable, cloud-based solution with a highly intuitive interface so your teams can quickly learn and use it. It helps Lifesciences companies to achieve production excellence. You can collect, manage, and track the necessary information efficiently in a secure, centralized database.
Why Choose Qualityze Enterprise Quality Management Solution for Lifesciences Industry?
Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Lifesciences industry because it has
Qualityze EQMS has a lot of value to offer to any organization with its customizable cloud-based software for Nonconformance Management, CAPA Management, Document Management, Change Management, Training Management, Audit Management, Permit Management, Supplier Quality Management, EBR Management, Field Safety Action Management, Complaints Management, Material Compliance Management, Forms Management, Incident Management, Calibration Management, Maintenance Management and Inspection Management.
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