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In the case of electronic data, this information is captured by an audit trail, which is an electronic data capture (EDC) system.This principle provides complete traceable information to the person who made the changes, when the change was made and why the change was made. In that case, it needs to be signed (initialed) with the date and an appropriate reason for editing the source data shall be included so that it is traced back to person X (Refer below image). Suppose person X updated (or) edited the recorded source data.Certain ways to trace back are by a signature or the initials of an individual X and the date it was observed or recorded (Refer below image) For example, if a person X is writing an investigation report all elements written (or) documented on the report shall be traced back to person X. When documenting any information on a piece of paper, every word written on it needs to be traced back to the person who has recorded it.This principle is one of my favourites in ALCOA. The raw data is traceable to the authorized person recording the data.
#Integrity plus plus
Now let us try to understand these ALCOA plus principles in pharma with a few practical examples (wherever applicable). However, in 2010, to amplify the concept of data integrity in pharma, USFDA extended the principles of ALCOA to ALCOA-C, which is also widely known as ALCOA + or ALCOA Plus. Before 2010, the first version of ALCOA principles of data integrity includes the following: Principles of ALCOAĪLCOA principle applies to all areas like research and development, manufacturing, supply chain, testing, etc. Since then, it has become a native term often used today by every person working in the pharmaceutical industry. Woollen from the FDA’s Office of Enforcement in the 1990s. Acronym ALCOA was first coined by Mr Stan W. ALCOA (also known as ALCOA plus) is a regulatory framework with a specific set of principles established by the USFDA (United States Food and Drug Administration) to ensure the integrity of the data in the pharma GMP environment is reliable & accurate at any given point in time.