In today’s fast-paced and highly regulated business landscape, industries, especially the pharmaceutical sector, require robust quality management systems to maintain compliance, streamline operations, and ensure audit readiness to tackle surprise audits. A reliable quality management software, such as Qedge, can be a game-changer in achieving your quality goals. But what are the key things to look for in an industry-ready quality management software? Let’s explore the essential features and capabilities that set a software apart.
The core Quality Processes within a quality management software lies in various activities and procedures that ensure consistent adherence to quality standards. This serves as a central hub for managing and optimizing quality-related workflows and activities.
An industry ready software solution should cover various quality activities such as:
1. Change control:
It helps to manage different change requests in controlled and coordinated manner which provides checks and balances in the quality system by tracking, reviewing and approving the changes. Sarjen’s EQMS change control management is capable to trigger dependent tasks such as impact assessment and risk assessment within itself. Impact Analysis and risk Analysis helps to identify the criticality of the proposed change and using the same analyses QEdge change control helps users in their decision-making process.
2. Deviation:
Deviations management plays a crucial role in ensuring product quality, purity, and strength. It involves identifying, recording, and evaluating any non-compliance with established GMP standards, approved requirements, specifications, and SOPs. An organization should look for a software which can provides a comprehensive audit trail that supports compliance with Part 11 requirements, ensuring organizations can rely on it for maintaining regulatory compliance.
QEdge EQMS offers a robust deviation management feature, ensuring systematic investigation and resolution. It facilitates root cause analysis and the implementation of immediate actions, corrective actions, and preventive actions (CAPA) to prevent recurrence. With QEdge EQMS, you can access critical quality data promptly, allowing for swift response to potential GMP compliance issues and global regulatory guidelines.
3. Investigation:
Investigation is essential for identifying root causes and effectively managing deviations and incidents complaint. An Investigation software offers configurable workflows with defined responsibilities for timely and conclusive outcomes. It enables effective CAPA management, ensuring regulatory compliance and preventing recurrence of deviations and complaints. QEdge provides complete and transparent management of investigation with full traceability on the source and implementation effectiveness.
Incorporating QEdge EQMS into your investigation processes is a strategic move that can significantly enhance your organization’s quality, compliance, and overall operational excellence. The streamlined workflows, real-time collaboration, advanced analysis capabilities, and comprehensive audit trails provided by QEdge EQMS empowers organizations to conduct investigations with precision and efficiency.
4. Corrective and Preventive Actions (CAPA):
An industry-ready quality management software should simplify the CAPA process. It should assist in identifying root causes, planning corrective actions, and tracking their implementation to prevent recurrence.
The risk-based Corrective and Preventive Action (CAPA) requirements need a properly documented system that defines the root cause of non-conformances, system outages or process problems, rectifies the problems, and prevents them from recurring. QEdge’s CAPA Management Software is integrated with risk management to provide you more insight into risk detection and corresponding prioritization with appropriate action plans. QEdge’s CAPA Management also helps reduce the Cost of Quality (CoQ) within an organization to improve product quality by implementing a continuously improving QMS system.
5. Market Compliant:
An industry-ready quality management software should prioritize compliance with regulatory bodies, such as the FDA or EMA. It should help manage documentation and ensure adherence to industry standards effortlessly. Our eQMS – Qedge is a compliant software as per the guidelines of 21CFR Part 11.
Look for a software that offers comprehensive training management capabilities. It should facilitate the creation, delivery, and tracking of training programs, ensuring that employees are competent and up to date with the latest industry practices.
Our Q-edge TMS software helps organizations with training as well as maintaining its records. With Qedge, manage your training and its records all at one place. Training management portal allows to define key responsibility areas for each employee or a group of employees. One can create training modules and upload training documents and contents. System tracks training requirements and training records for each employee and generate training gap, as may be the case.
Efficient document control is crucial in maintaining data integrity and version control. Managing the documents is tiring, space consuming and timely task when done manually. Seek a software that provides centralized document management, easy access, and robust security measures to protect sensitive information.
With Qedge, manage all the data at one place and can be accessed quickly anytime. This helps in reducing paper wastage, costs and time. Apart from that, using Qedge can help in avoiding the risks such as loss of documents. With this software, one can manage complete life cycle of:
Apart from the above 3 major modules, an organization should look for the following things in a QMS software.
Scalability:
Scalability is a crucial feature to consider when selecting an industry-ready software. By considering scalability as a key feature, you can future proof your software investment and ensure that it can grow alongside your organization. This allows you to scale your quality management processes and adapt to evolving business requirements efficiently.
Compliance:
Compliance is a critical aspect to consider when selecting an industry-ready software. By selecting a compliant software solution, you can mitigate compliance risks, streamline regulatory processes, and ensure adherence to industry standards and guidelines. It helps organizations maintain regulatory compliance, avoid penalties, and build a culture of quality and compliance within the organization.
Security:
Security is a vital aspect to consider when selecting an industry-ready software. By prioritizing security in your software selection process, you can safeguard your data, protect against unauthorized access, and maintain the privacy and integrity of your sensitive information.
Selecting the right industry-ready quality management software is a pivotal decision that can significantly impact a company’s operational efficiency and product excellence. By keeping a keen eye on features such as robust customization options, real-time analytics, seamless integration, a user-friendly interface, and adaptable scalability, businesses can ensure that they are investing in a solution that aligns with their unique needs and future growth. As industries continue to evolve, embracing quality management software that not only meets current requirements but also has the potential to stay ahead of emerging challenges will undoubtedly be a key driver for success in the competitive landscape.