QMS – Quality Management System
A digital QMS helps life sciences organizations overcome the challenges of traditional quality management, such as costs, complexity and risk, and puts them in a position to take advantage of Industry 4.0 technologies.
Why Is a Digital QMS Important?
The evolution of quality management system (QMS) software is speeding up as organizations find new ways to apply Quality 4.0 capabilities to complex manufacturing and distribution processes. A digital quality solution enables companies to leverage these innovative leaps in quality management.
TrackWise Digital QMS enables organizations to create and manage core quality processes with intelligent workflows to streamline reviews and respond to issues quickly. With QualityWise.ai organizations can leverage AI-augmented quality processes to automatically suggest categories and correlate quality events, unlocking the value of operational data to augment decisions.
Benefits of a Digital QMS
Does your QMS platform offer easy integration with your ERP, CRM, LIMS, or other systems? To effectively manage quality, your solution needs to communicate and integrate with the systems that produce quality data.
An effective system automatically creates an audit trail, meets e-signature requirements, and provides other important compliance essentials.
A cloud-based quality management system includes a multitude of people responsible for data security and who conduct daily system penetration testing. In doing so, they can quickly identify and address any security threats and ensure the protection of client data.
Cloud-based quality management solutions integrate seamlessly with external systems. This enables manufacturers to get insight into the data, in real-time, through use of a cloud-based centralized repository. This data can be accessed quickly and easily to analyze and report on.
Quality management software help organizations transition to Quality 4.0 and ultimately achieve proactive quality, by enabling them to access enormous amounts of data in real-time and providing the ability to compile, store and access it quickly and effectively.
QMS Challenges with Manual or Legacy Quality Systems
Legacy or manual technology will not meet the needs of today’s complex business environments. Companies that use a traditional, manual quality management approach are often faced with a set of core challenges.
Industry best practices are typically well established and following them not only ensures quality, but it also helps companies meet compliance.
Minimal dependence on IT resources will mean faster implementation and, in the case of digital QMS solutions, ensure on-time maintenance and upgrades.
Quality impacts every aspect of a life sciences manufacturer’s operations. However, with legacy QMSs the quality team typically operates in a silo, making it impossible to get insight into other systems in which key data resides. As a result, the quality team has limited visibility to valuable insights throughout the enterprise.
What to Look for in a Quality Management System
Leverage Sparta’s Quality Process Accelerators (QPAs)
Sparta’s QPAs are intelligent, pre-validated quality processes that are built on almost three decades of industry best practices and help shorten time to value.
The nonconformance QPA records data about situations in which a product or device has not conformed to standards.
The CAPA QPA enables organizations to track and manage the process of carrying out CAPA plans, automate verification of effectiveness over time, and provide seamless traceability to related quality processes, including change control and training.
The audit management QPA helps companies monitor critical processes, identify gaps and improve quality.
The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected.
Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA.
Enables users to capture critical information using a simple, browser-based interface and share it with quality and compliance teams from anywhere, on any device.
Use the extension request QPA when a time-sensitive record cannot be completed on time. It contains information on the record, the original due date, a suggested new due date and the reason for the delay.
Respond to adverse events faster with the quality events QPA and reduce the amount of time it takes to act on quality and safety issues.
The batch release records contain information on a grouping of products that are being manufactured together.
The complaint handling QPA provides the ability to log, respond to and investigate complaints.
Risk Management enables companies to seamlessly link the risk process to other quality management processes.
The supplier quality management QPA enables organizations to manage and collaborate with suppliers and contract manufacturers across your supply chain.
Significantly reduces the time, cost and resources needed to track product submissions with regulatory agencies around the globe using the product registration tracking (PRT) QPA.