Data integrity:- Data integrity denotes about originality, consistency, accuracy and trustworthy of data. In simple words we can say there is no any alterations with respective data.
Another definition is as below:-
"Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)".
For data integrity a guideline available and known as ALCOA. Now + version of ALCOA is being followed. Here we are going to discuss abbreviation of ALCOA+.
A:- Represent to Attributable. Means who is the creator or generated the respective data.
Data must contains the details by whome and when it was created. The purpose of Attributable tool to find out the creator of data.
L:- Represent to Legible. Means data should be easily readable. No any confusions to identify the words or number.
C:- Represent to contemporanious. Data record should be contemporanious in nature. It means data shows at which time it was recorded also give assurance of as it was recorded at its real time.
If any corrections made later that should be addressed at current date and time.
O:- Represent to Original. This tool used to check the authenticity of data. Means data should be recorded on true copy i.e. authentic document. Also assure as data recorded at first time on the original record.
Ex. If any one note the value on his/ her hand and later copy the same on authentic document. Such type of discrepancy considered as violation of Original record.
A:- Represent to Accurate. It means data should be error free. No any mistakes should be available. If any corrections done later, the supporting documents should be available and the corrections to be done on current date.
The + version is combination of CCEA. Let's discuss on abbreviation of CCEA.
C:- Represent to Complete. It means all the set of data should be available till life time including any ammendment which was added later.
No any deletion has been taken from date of documentation.
C:- Represent to Consistent. It means data should be chronologically arranged including any additions with date and time stamp. The consistency should be monitored by various audits or periodically review.
This tool help for proper understanding of data in sequential order.
E:- Represent to Enduring. It means the material used to record the data should be long lasting for proper readable.
For example if any ink used to print the data which got fainted after some time then it will be difficult to read the correct value after long time and interpretation of data will be wrong.
A:- Represent to Available. It means data should be stored or arranged in such a manner, which will take very short time to get back when required later.
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.