ALCOA to ALCOA Plus for Data Integrity : Pharmaceutical Guidelines
ALCOA to ALCOA Plus for Data Integrity
ALCOA was an tool to implement the data integrity in pharmaceutical manufacturing facility but ACLOA + made this tool more powerful and sharp. Data security has its
importance in pharmaceuticals.
The term Alcoa is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. Alcoa was then expanded to Alcoa
Plus (Alcoa +), by the addition of a few more concepts which are; Complete, Consistent, Enduring and Available.
Over time, the concept of Alcoa plus has been adopted by various industries, as a framework for ensuring that data security and integrity (data
protection) is observed and maintained. Alcoa Plus has been implemented and is in use by various big bodies, such as the FDA, WHO, and GAMP.
ALCOA is all about data quality.
In order to understand the concept better, below we will break down Alcoa Plus and define each part of the acronym:
Attributable dictates that any data should be easily identified to the person who did the data collection, place of origin and the time of data collection
should also be noted down. in the case of alteration of data, the person making the corrections should also be noted down.
Legible data means the data can be easily read. This attribute should be ensured both in the short and long term, therefore the materials used in
recording and collecting the data should be durable.
Data recorded should be contemporary in nature. This dictates that the time of data collection should correspond accurately with the time of data
recording. Any data collection should have a date and time, and the same should be ensured in the case of any later corrections.
In order to preserve the meaning and integrity of data, the original records should be preserved, meaning the material used should be durable. in the
case of duplicates, the creator of the original records should confirm the authenticity of the copies.
For any data to be viable, it should be error free. In the case of any amendments, there should be accompanying documents to support the changes.
The data should be complete and viable. Data quality must be maintained.
When data is complete in nature, it means there is no deletion that has taken place from the date of documenting. This includes any changes that
have been made during the life of the data.
The data should be chronologically arranged, with time stamps included for any addition to the original data. Consistency should be ensured by
applying various audits over the life of the data.
The material used to record the data should be in a manner which will last a long duration of time without losing the readability.
Data should be accessible whenever needed, over the life of the data. Availability ensures the data meets it’s use, since it can be applied when the
Every organization is built around data, either in the form of research or normal day to day records. This data is crucial for future references, or when
the management wishes to make decisions depending on past occurrences. Data is also used more importantly during profitability assessments by
top level management. This brings up the need for data integrity, a need easily satisfied by application of the Alcoa plus concept.
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