ALCOA+ is a system that is used to implement data integrity in the pharmaceutical manufacturing industry. The term ALCOA was introduced by US-FDA in the starting. In the earlier stage, it was ALCOA only, after some period of time ALCOA+ was introduced with some powerful tools that made it more efficient. The main motive of this framework was to integrate data and data security.
The European Medicines Agency (EMA) added another four items to round out the concept: Complete, Consistent, Enduring and Available. This highlights data management requirements that were somewhat implicit in the original five. We commonly refer to this extended concept as ALCOA+.
These days, It has become more essential to adopt ALCOA+ for compliance of FDA and GMP practices. Principles of ALCOA+ are being more important to follow GMP and GLP practices also.
ALCOA Principle to maintain data integrity:
The ALCOA stands for
A Attributable,
L Legible,
C Contemporaneous,
O Original and
A Accurate.
However, ALCOA+ is added with some more significant features that are Complete, Consistent, Enduring and Available.
ALSO READ: SOP for Data Integrity
Attributable:
All generated data must be traceable to the applicable instrument and the person who generated the data. The date and time of the collection or generation of data should also be recorded. For example, A correction in the record should be initialed and dated to show when and who made the correction.
Legible:
Data should be easy to understand, recorded permanently, and preserved in its original form. There should be no overwriting, All the corrections need to be clearly written with proper justification. For example, when making corrections to a record, it should be struck using a single line, to ensure the data is legible.
Contemporaneous:
Contemporaneous means data should be recorded at the time work is performed. Date and time entries should follow in chronological order. Data should never be backdated.
Original:
Source data or Primary is a medium in which the data point is recorded for the first time. This could be an approved form or protocol or a dedicated notebook.
Accurate:
To achieve accurate data, the data should be error-free, complete, and truthful and it should reflect the observation made. If any correction is made to the data, it should record who has made the corrected and when it is made.
After the update of the original ALCOA principles to ALCOA+. The ALCOA principles remain as and four additions are :
Complete
Consistent
Enduring
Available
Complete:
Information that is critical to recreating and understanding an event. This would include any repeat or reanalysis performed on a laboratory test sample.
Consistent:
The data are presented, recorded, dated, or time-stamped in the expected and defined sequence.
Enduring:
The data or information must be maintained, intact, and accessible throughout their defined retention period.
Available:
The data or information must be able to be accessed at any time during the defined retention period.
Why is ALCOA+ important in validation and data integrity?
After the success in the pharmaceutical industry, other industries also adopted ALCOA+ as a framework for data integration and the security of data. Some big regulatory bodies like FDA-US Food and Drug Administration, WHO, and GMP also used and pushed to adopt the ALCOA+ framework.
Data Integrity And Validation
In the era of the information revolution, Data integrity is very crucial for every validation process in every manufacturing industry. Data integrity allows manufacturers to review their in-process loss, quality errors, cost efficiency and future plans.
ALCOA+ is a quite good framework to ensure data security and data integrity with less efforts. If the data is available easily and complete in nature that helps to make corrective action plans for past discrepancies.
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Quality Assurance
