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Failure Reporting (FR). The failures and the faults related to a system, a piece of equipment, a piece of software or a process are formally reported through a standard form (Defect Report, Failure Report). Analysis (A). Perform analysis in order to identify the root cause of failure. Corrective Actions (CA).
An alert system to identify process malfunctions that lead to deviations from quality standards. A framework for gathering and analyzing data of final product quality and process consistency. Analysis should include source materials consistency and manufacturing equipment condition; and data should be collected in a format that allows for long ...
Predictive engineering analytics (PEA) is a development approach for the manufacturing industry that helps with the design of complex products (for example, products that include smart systems). It concerns the introduction of new software tools, the integration between those, and a refinement of simulation and testing processes to improve ...
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
DataOps is a set of practices, processes and technologies that combines an integrated and process-oriented perspective on data with automation and methods from agile software engineering to improve quality, speed, and collaboration and promote a culture of continuous improvement in the area of data analytics. [1]
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 ]
An intelligent maintenance system is a system that uses data analysis and decision support tools to predict and prevent the potential failure of machines. The recent advancement in information technology , computers, and electronics have facilitated the design and implementation of such systems.
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2]
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