What is ALCOA

INTRODUCTION: ALCOA is an abbreviation which stands for attributable, legible, contemporaneous and accurate. ALCOA data integrity is used by industries because it ensures that data attain the fundamental elements of quality and also helps in ensuring the integrity of data. These five elements of data are important in industrial data lifecycle, good documentation and also in data integrity initiatives.
The five elements of ALCOA are discussed below.

ATTRIBUTABLE
Data collected or generated must be able to be attributed to the one collecting or generating the data. This is inclusive of person performing an action and when it can be recorded an electronic system or manually by initialing and dating a paper record.
Here is an example:
when conducting an exercise of validation, results of the tests must be dated and made initial by the one conducting the test.
Any adjustment of the monitoring system ought to be conducted by a legal user and the change details to be put in the audit trail. A correction made on the lab record also needs to be initialed and dated. Something to note is that it is vital to maintain the signature log for identification of initials and aliases of the ones who completed paper records.

LEGIBLE
All pharmaceutical documents should be legible, that is it should be readable and permanent. If data records are permanent and readable they can be easily and accessed throughout the entire data lifecycle. This will help in easy retrieval of previous data in the pharmaceutical industries if needed.

CONTEMPORANEOUS
This means the recording of the results, data or measurement at the time when the work is being performed. When the work is executed, it should be dated and stamped at the time of its execution. The date and stamps must come in the order of execution. This will help in ensuring the credibility of data in the pharmaceutical industries.
for example in the pharmaceutical industry:
when conducting a validity protocol, results of tests performed should be recorded in the sequence as they happen.
The recorded results should then be dated and time stamped and then logged in the electronic systems.

ORIGINAL
Primary data or source data is another referral name for original data It refers to where/how the data/information is preserved for the first time/the primary medium where data is recorded. This medium could be a form or an acceptable protocol , or a database, or a notebook. It is very vital to deeply understand the source from which your primary data will be obtained so as to ensure preservation of content and meaning.
For instance in the industry, make sure validation test are being recorded on the required protocol because recording test results in a handbook may introduce errors. If the original data is handwritten and it must to be preserved in the electronic systems, make sure a true copy of the records is brought. The copy should first be confirmed it is complete and then put into the system to implement ALCOA in pharmaceuticals.

ACCURATE
so as to ensure accuracy in data and records, the data needs to heave the following characteristics:

• it ought to be free from errors.
• it should be complete.
• it should be reflective to the observation.
• any editing made on the recorded data should be documented and all amendments be annotated. To ensure accuracy of the data collected you can apply the following measures:
• ensure there is a witness to check for critical data collection.
• place accuracy checkers in the electronic system.
• place controls or verifications on data entry an example, temperature results to be recorded within a range of 0–100 degrees Celsius.
  These are the five what is ALCOA principles which help in ensurance of data integrity.

This article is written by Ankur Choudhary. Follow Pharmaguideline on Facebook

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