Quality management system is defined as “a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction.” This definition is accurate, but if your business falls within a highly regulated industry, a quality management system (QMS) stands for much more than that.
Customer requirements and satisfaction is the overall goal in a highly regulated industry such as life science, but the regulatory bodies are the hardest to please (and for a good reason). Organizations use QMS frameworks to guide continuous improvement efforts and adopt data for evidence-based decision making. Organizations in highly regulated industries seek certification with globally recognized standards such as ISO 9001 to improve quality through transparency, documentation, and systemic approaches to improvement. The adoption of Quality Management Software typically supports modern QMS.
Switching to a robust electronic QMS can support compliance, profitability, and the development of a quality-driven culture. While there are various guidelines for a robust electronic QMS, the best-known systems for total quality management all represent the list below.
- Document management organizes all documents into a centralized database with approval workflows and audit trails. Electronic QMS documentation allows for easy and fast communication of documentation transfers, process monitoring, a source of evidence for conformity. Electronic documents eliminate document redundancy, reduce the risk of manufacturing products with out-of-date SOPs, and create efficiency in organizations.
- Reporting management allows you to share print-ready and interactive reports and dashboards with countless users. Whether you are a manager wanting to view more details in a report or an analyst who needs to visualize data. It is important that users can get what they need without delay so they can utilize that information to accomplish various goals.
- Inspection management allows companies to streamline regulatory inspections by tracking all requests and logging notes in a single platform. Real-time updates and in-system notifications ensures that your team is responding to requests in an efficient manner at the time of an inspection.
- Audit management provides the flexibility to schedule, plan, and execute various types of audits all within a single, comprehensive platform so you can manage your entire audit lifecycle. This feature reduces risk by enforcing consistent and harmonized processes of vendors while securely managing all information in a centralized system. In addition, it facilitates compliance with global government regulations and industry standards. This provides management the data needed to evaluate audit system effectiveness and make changes where necessary.
- Learning management provides your company’s employees with the documents needed to be able to train on processes, take quizzes, upload files, and sign off on these educational courses all in one place. Keep up to date on training and have trainers review answers for completed assignments to educate your employees as well as avoid any non-conformities.
- Product lifecycle management allows users to create a bill of materials and build products through a user-friendly platform. Track all updates to products and components by seamlessly applying the change to all products, or simply swap out for just one product, all through cloud software.
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