Understanding of ALCOA to ALCOA+

The ALCOA acronym was introduced by Stan W. Woollen in the FDA office early 1990's. The term ALCOA was introduced by US-FDA in the starting for the data integrity in pharmaceutical manufacturing industry. In earlier stage it was ALCOA only, after some period of time ALCOA+ introduced with some powerful tools that made it more efficient. The main motive of this framework was to integrate data and data security.

ALCOA is outdated and ALCOA+ is the updated concept. It just like GMP to cGMP.

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:

The ALCOA stands for

A ?? Attributable,

L ?? Legible,

C ?? Contemporaneous,

O ?? Original and

A ?? Accurate.

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 (Readable):

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 (Online Record):

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 (Error Free):

To achieve accurate data, the data should be error-free, complete, truthful and it should reflect the observation made. If any correction is made to the data, it should record that who has made the corrected and when it is made.

ALCOA+

1. Available
2. Enduring
3. Consistent
4. Complete

• Available:

The data or information must be able to be accessed at any time during the defined retention period.

• Enduring:

The data or information must be maintained, intact, and accessible throughout their defined retention period.

• Consistent:

The data are presented, recorded, dated, or time-stamped in the expected and defined sequence.

• Complete:

Information that is critical to recreating and understanding an event. This would include any repeat or reanalysis performed on a laboratory test sample.

Summary of ALCOA+ Principle

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, GMP also used and pushed to adopt ALCOA+ framework.

Data Integrity And Validation

• In the era of information revolution the 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 eff orts. If the data is available easily and complete in nature that helps to make corrective action plans for past discrepancies.