The Acronym Architecture Series
Article Two: QMS (Quality Management Systems)
Lab software products are often identified by acronyms meant to differentiate them from one another, but the sheer volume of software available can leave decision-makers feeling confused and overwhelmed about what tools are truly required to be modern, compliant and efficient.
In the last edition of this informational series, we examined CMMS software (Computerized Maintenance Management Systems). This week, we’ll take a look at QMS (Quality Management Systems).
QMS (Quality Management Systems)
QMS, or Quality Management Systems, are a class of software system designed to align an organization’s processes and activities to optimize efficiency and maintain regulatory compliance. By centralizing SOPs, policies, resources, and documentation, the strategic direction of a company falls into greater alignment. The use of QMS also helps to put an added emphasis on customer requirements and satisfaction.
QMS platforms are useful for any operation in need of process and resource management, particularly in regulated environments. In medical device and pharmaceutical manufacturing, the two primary guidelines for QMS are US FDA 21 CFR 820 (GMP) and ISO 13485, and the best platforms designed for these industries are compliant with one or both. In terms of features, modern QMS platforms include many of the following:
• Workflow Management (Production & Process)
• Document Creation and Version Control
• Design Control
• Facility Control
• Compliance Tracking and Documentation
• Corrective and Preventive Actions (CAPA)
• ISO Standards Management
• Supplier Visibility
• Material Control
• Employee Training
While often a requirement in many operational environments, QMS systems also add inherent value to an organization via:
• Improved process and resource efficiency
• Cost savings via reduced error
• Enhanced ability to meet customer requirements
• Improved risk management and avoidance through centralized documentation
• Quality control through transparency and standardization
• Scalability through documentation of process
Quality Management Systems can range in terms of their features and therefore their pricing, but the value to your organization is myriad. The best QMS platforms will also allow for interoperability with other critical systems such as CMMS and LIMS, which we will discuss in our next edition of the Acronym Architecture Series
Contact the Qualer team to learn more about digitization strategies and how they might benefit your laboratory.
Up next in this series: Laboratory Information Management Systems (LIMS)