ALCOA Plus in data integrity
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#Pharma_Mentors and Guide for Industrial Pharmacy present an innovative method to explain #ALCOA_Plus of #Data_Integrity.
ALCOA is an acronym and stands for Attributable, Legible, Contemporaneous, Original and Accurate.
ALCOA was then extended by adding several more concepts to ALCOA PLUS: Complete, Consistent, Persistent and Available.
To better explain the concept of ALCOA Plus, we will break down Alcoa Plus and define each part of the acronym:
Attributable
Attributability means that the data can be easily attributed to the person who carried out the activity and collected the data, and that the place and time of the activity must be identifiable.
In the case of a correction, it must also be noted who made the correction, when and why the correction was made.
Readable
Readable data means that the data can be easily read. This attribute should be ensured both in the short term and in the long term.
Therefore, the materials used to record and collect data should be durable and the data should be easy to read.
At the same time
The recorded data should be current.
Record observations as they are made.
All recorded data and information should be dated and time stamped.
Original
Retain original records to ensure the relevance and integrity of the data.
An original record is the first recording of information in electronic or paper form.
If paper is used to capture information, it should be a controlled document issued by the quality unit.
In the case of duplicates, the creator of the original documents should confirm the authenticity of the copies.
Exactly
In order for data to be usable, it must be error-free.
In case of any changes, there should be accompanying documentation to support the changes.
The data must be complete and reliable. The data quality must be guaranteed.
Complete
If data is complete, it means that no deletions or omissions have been made since the date of documentation.
This includes any changes made during the lifetime of the data.
Consistent
The data should be arranged chronologically and include time stamps for all additions to the original data. Consistency should be ensured by various checks throughout the life of the data.
Permanently
The material used to record the data should be such that it can be preserved over a long period of time without losing readability.
Available
Data should be accessible on demand throughout its lifetime. Availability ensures that the data serves its purpose because it can be used when needed.
ALCOA Plus maintenance is critical to ensure that the final products meet all required quality standards. Essentially, it is a process of maintaining and ensuring the integrity, accuracy and consistency of data throughout its lifecycle.
ALCOA is an acronym and stands for Attributable, Legible, Contemporaneous, Original and Accurate.
ALCOA was then extended by adding several more concepts to ALCOA PLUS: Complete, Consistent, Persistent and Available.
To better explain the concept of ALCOA Plus, we will break down Alcoa Plus and define each part of the acronym:
Attributable
Attributability means that the data can be easily attributed to the person who carried out the activity and collected the data, and that the place and time of the activity must be identifiable.
In the case of a correction, it must also be noted who made the correction, when and why the correction was made.
Readable
Readable data means that the data can be easily read. This attribute should be ensured both in the short term and in the long term.
Therefore, the materials used to record and collect data should be durable and the data should be easy to read.
At the same time
The recorded data should be current.
Record observations as they are made.
All recorded data and information should be dated and time stamped.
Original
Retain original records to ensure the relevance and integrity of the data.
An original record is the first recording of information in electronic or paper form.
If paper is used to capture information, it should be a controlled document issued by the quality unit.
In the case of duplicates, the creator of the original documents should confirm the authenticity of the copies.
Exactly
In order for data to be usable, it must be error-free.
In case of any changes, there should be accompanying documentation to support the changes.
The data must be complete and reliable. The data quality must be guaranteed.
Complete
If data is complete, it means that no deletions or omissions have been made since the date of documentation.
This includes any changes made during the lifetime of the data.
Consistent
The data should be arranged chronologically and include time stamps for all additions to the original data. Consistency should be ensured by various checks throughout the life of the data.
Permanently
The material used to record the data should be such that it can be preserved over a long period of time without losing readability.
Available
Data should be accessible on demand throughout its lifetime. Availability ensures that the data serves its purpose because it can be used when needed.
ALCOA Plus maintenance is critical to ensure that the final products meet all required quality standards. Essentially, it is a process of maintaining and ensuring the integrity, accuracy and consistency of data throughout its lifecycle.
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