It was introduced and still used by FDA – the US Food and Drug Administration. The main principle of ALCOA is to minimize the risk of data integrity. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). It is also a process of maintaining and assurance of accurate and consistency of data over its whole life cycle.ĭata integrity refers to the completeness, consistency, and accuracy of data. No error or editing was performed without documented amendments to ensure the accuracy of the data and records.Ĭonsistent in a generation of record and application of date and time stamps in the expected sequence.ĭata should be recorded in a controlled worksheet in laboratory notebooks or validated Electronic systems.ĭata need to be available and accessible for review for audit and inspection over the lifetime of the record.ĭata integrity is a key element in pharmaceutical industry to ensure products meet all the quality standard parameters up to the end of products. The information must be recorded as original or in a certified true or original copy this may be an acceptable protocol or a database or a notebook. The data should be recorded at the time and date of work performed. The collected data must be attributed, who performs the action and when, if a record is changed, who did it and why to be recorded.ĭata must be recorded permanently in a durable record medium and easy to read. Where ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate and ‘+’ (Plus) means Enduring, Available, Complete and Consistent. ![]() ![]() ALCOA/ALCOA+ is a framework or set of principles that ensures data integrity.
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