Glossary

GAMP 5 provides guidance, including establishing a common language and terminology for computerized systems. This guidance includes the definition of

Logbook: In the pharmaceutical industry, a logbook is an official, chronologically ordered record used to document specific activities, events, conditions,

Gemba Walk in Pharmaceutical Production: A Key to Continuous Improvement Gemba Walk, literally translated as “go to the real place,”

Continuous improvement is a process of regularly evaluating products, services, processes, or systems and making targeted improvements to increase quality,

Predictive Maintenance – Predictive maintenance is the process of predicting when a system will fail before it actually happens. The

Smart factory is a unique factory automation system. It’s a growing industry, with a lot of opportunities. The current worldwide

Master Batch Record (MBR) means a document defining manufacturing methods, materials and other procedures, guidelines and controls related to product

An Electronic Batch Record (EBR) is a digital production record, an electronic record of a production, an electronic copy or

Industry 4.0 – the Fourth Industrial Revolution, or the concept that the development of industry has entered a new phase,

Overall Equipment Effectiveness (OEE) is a commonly used indicator in manufacturing plants. It allows to determine how efficient is a

Enterprise Resource Planning, or ERP for short, is a process and information system for managing resources in an enterprise. It