ISO/IEC 27001 is an international standard to manage information security. The standard was originally published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in 2005,[1] revised in 2013,[2] and again most recently in 2022.[3] There are also numerous recognized national variants of the…
A quality management system (QMS) is 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 (ISO 9001:2015).[1] It is expressed as the organizational goals and aspirations, policies, processes, documented…
A warehouse management system (WMS) is a set of policies and processes intended to organise the work of a warehouse or distribution centre, and ensure that such a facility can operate efficiently and meet its objectives. In the 20th century the term ‘warehouse management information system’ was…
Enterprise resource planning (ERP) is the integrated management of main business processes, often in real time and mediated by software and technology. ERP is usually referred to as a category of business management software—typically a suite of integrated applications—that an organization can use to collect, store, manage and interpret…
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages,[1] cosmetics,[2] pharmaceutical products,[3] dietary supplements,[4] and medical devices.[5] These guidelines provide minimum requirements that a manufacturer must meet to…
Computerized system validation (CSV) (Computerised system validation in European countries, and usually referred to as “Computer Systems Validation”) is the process of testing/validating/qualifying a regulated (e.g., US FDA 21 CFR Part 11[1]) computerized system to ensure that it does exactly what…
SCADA (an acronym for supervisory control and data acquisition) is a control system architecture comprising computers, networked data communications and graphical user interfaces for high-level supervision of machines and processes. It also covers sensors and other devices, such as programmable logic controllers, which interface with process plant or machinery. The…
A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory‘s operations. Key features include—but are not limited to—workflow and data tracking support, flexible architecture, and data exchange interfaces,…
Manufacturing execution systems (MES) are computerized systems used in manufacturing to track and document the transformation of raw materials to finished goods. MES provides information that helps manufacturing decision-makers understand how current conditions on the plant floor can be optimized to improve production output.[1] MES works…