Essential Components of Quality Management Systems
A high-caliber electronic QMS is comprised of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing all essential components of quality management systems (i.e., document control, change control, training control, audits, corrective/preventive action, customer complaints, and other crucial documents- and forms-based quality and business processes) under a single Web-based platform.
Without specifically designed software for managing quality processes such as corrective and preventive actions (CAPA), organizations may not realize how inefficient their processes are until they’ve already lost to the competition. For instance, when a company doesn’t meet the fundamental components of quality management systems, they may end up running full CAPA processes that should have never been instigated in the first place simply because that is the way things have always been done internally and no one has ever bothered to fix faulty processes. Such reliance on outdated processes and paper-based systems inevitably results in wasted time and increased costs because valuable resources are being focused on the wrong problems and spread too thin.
Benefits of Top-of-the-Line Quality Management System Software Solutions
Here are a few of the fundamental components of quality management systems that need to be considered when organizations are seeking to implement an electronic QMS solution:
- The QMS solution should give your organization the ability to accelerate and automate essential quality processes like CAPA, customer complaints, deviations, out-of-specifications, change control, audits, non-conformance, and so forth.
- The technology should provide the ability to automate documentation processes such as document change, distribution, notification, and approval in order to accelerate compliance and minimize the time it takes for products to get to market.
- A system that is ready right out of the box is valuable, but it should also customizable enough to fit your individual organizational needs.
- A QMS system that is specially designed to be implemented and validated within a reasonable time frame can drastically reduce overall costs and maximize your return on investment.
- A good quality management system must ensure that the integrity of regulatory documentation and standard operating procedures (SOPs) can be maintained throughout a document’s lifecycle.
- The QMS software should also offer the capability to route documents electronically along pre-defined workflows for more efficient distribution, collaboration, and approvals.
Most companies doing business in regulatory environments require the following components of quality management systems:
- A Web-based quality management architecture
- Accelerates compliance
- Must facilitate compliance with stringent regulatory requirements such as 21 CFR Part 11
- Supports standard databases used in life sciences and similarly regulated environments
- Takes advantage of form-to-form launching
- Offers the capability to track forms by status or history (as “in process,” “complete,” etc.)
- Maintains active links so users can review a completed process to see what event caused or merged with another event
- Integrates with existing document repositories and enterprise applications such as ERP, LIMS, etc., without custom coding
- Integrates forms with training control (i.e., any change to a document or process that calls for new training should automatically trigger training tasks)
Bringing Together All the Vital Components of Quality Management Systems
A state-of-the-art quality management software solution allows a regulated company to enhance the efficiency of its quality systems while also ensuring that those systems are also compliant, connected, and cost effective. Proven QMS management software solutions are vital components of maintaining quality management system fundamentals and achieving regulatory compliance. Plus, robust QMS software can be invaluable in helping companies keep pace with industry trends. Companies may vary in scope and size, but if they’re doing business in environments where regulatory bodies are pushing toward the usage of electronic systems, it is mandatory that they effective quality management software solutions to enhance and harmonize their overall quality processes.
An automated QMS management system also connects all departments, product lifecycles, and quality processes. User-friendly quality software helps simplify, streamline, and effectively manage quality control processes. In addition, an electronic system’s ability to automatically route tasks and escalate them when necessary ensures that task completion, approval cycles, and inter-departmental input occur in a timely manner. When quality is built directly in to the QMS system, every department—from engineering to quality assurance and manufacturing to regulatory —stays connected.
A QMS software solution helps companies overcome the common challenges discussed above and also establish solid QMS fundamentals. Consider, for instance, that an electronic system can help users effectively determine root causes by providing problem-solving algorithms based on critical thinking logic, thus preventing those issues from reoccurring. Electronic QMS systems connect processes and propagate the CAPA process throughout the entire organization. So, for example, the resolution of a CAPA can be set to cause the system to automatically trigger a change control which prompts a change in an SOP and coordinates retraining of employees on that SOP.
When a company possesses all the necessary components of quality management systems, companies can improve both quality and speed to market. The bottom line is that if all the QMS bases are covered, more products of a higher quality can be manufactured at a greatly reduced cost.
To learn more about MasterControl’s Components of Quality Management Systems (QMS) solutions, contact a MasterControl representative.