Can any body explain the ALCOA with respect to data integrity and how we avoid data integrity Issues..

Parveen    |    03-07-2017

4 Answers:

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Mahak    |    03-02-2018

Very well explained concept of data integrity. 


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Pharmabuddy    |    02-02-2018

Well said about the expectation of minimum requirement of securing data and maintaining is integrity, however, when we talk on bigger picture there is much to discuss beyond ALCOA Which currently we call as ALCOA+ (nowadays this is frequently used by the FDA, WHO, PIC/S and GAMP – Data Integrity), this neatly requires all data to have the following qualities:

  • Attributable — Who acquired the data or performed an action and when?
  • Legible — Can you read the data and any entries?
  • Contemporaneous — Documented at the time of the activity.
  • Original — A written printout or observation or a certified copy thereof.
  • Accurate — No errors or editing without documented amendments.
  • Complete — All data including any repeat or reanalysis performed on the sample.
  • Consistent — All elements of the analysis such as the sequence of events follow on and are date or time stamped in the expected sequence.
  • Enduring — Not recorded on the back of envelopes, cigarette packets, sticky notes, or the sleeves of a coat but in notebooks or electronic media in the data systems of instruments.
  • Available — Can be accessed for review and audit or inspection over the lifetime of the record.

Atleast if we achieve these above we can say that now integrity of the data is maintained. Its easier to follow when we have paper based system but bit complex when we introduce computerised system to maintain our data. Consideration to be given to all these attributes as part of the ‘meta-data’ and also to consider how we can retrieve, store and archive data across it’s entire life cycle. So significance of "+" is getting more focus and expanding with new requirements and expectations to make data more integral.

Hope you like this article...Please comment below with your like and suggestions.


pharmabuddy.jpg

Pharmabuddy    |    02-02-2018

Well said about the expectation of minimum requirement of securing data and maintaining is integrity, however, when we talk on bigger picture there is much to discuss beyond ALCOA Which currently we call as ALCOA+ (nowadays this is frequently used by the FDA, WHO, PIC/S and GAMP – Data Integrity), this neatly requires all data to have the following qualities:

  • Attributable — Who acquired the data or performed an action and when?
  • Legible — Can you read the data and any entries?
  • Contemporaneous — Documented at the time of the activity.
  • Original — A written printout or observation or a certified copy thereof.
  • Accurate — No errors or editing without documented amendments.
  • Complete — All data including any repeat or reanalysis performed on the sample.
  • Consistent — All elements of the analysis such as the sequence of events follow on and are date or time stamped in the expected sequence.
  • Enduring — Not recorded on the back of envelopes, cigarette packets, sticky notes, or the sleeves of a coat but in notebooks or electronic media in the data systems of instruments.
  • Available — Can be accessed for review and audit or inspection over the lifetime of the record.

Atleast if we achieve these above we can say that now integrity of the data is maintained. Its easier to follow when we have paper based system but bit complex when we introduce computerised system to maintain our data. Consideration to be given to all these attributes as part of the ‘meta-data’ and also to consider how we can retrieve, store and archive data across it’s entire life cycle. So significance of "+" is getting more focus and expanding with new requirements and expectations to make data more integral.

Hope you like this article...Please comment below with your like and suggestions.


manish.jpg

Manish    |    31-01-2018

ALCOA principle guides how to maintain the integrity of the data. The principle focus on how to document and maintain a data.

ALCOA principle itself a wide concept and integrity of any data surrounded by it.

A- Attributable means a data shall be documented in a way so that it can reflect that who has performed the activity and when the activity is performed.

L- Legible means the data shall be documented in a readable form by everyone and remains it integrity for long term so as to avoid any alteration in the data.

C- Contemporaneous means that the data shall be documented online when the activity performed so that accuracy of the data can be trusted.

O- Original means the true copy of the data shall be maintained so as the correctness of the data can be verified. It also means that any transcription from the meta data shall also be original in representative data.

A- Accurate means the data shall be free from error if there are any errors those errors are corrected as per GDP. Data shall not be incomplete and any information shall not be hide in the data.

So, the ALCOA principle ensure the integrity of the data and if any of the five principle of ALCOA not followed during documenting any data than it can be considered as integrity issue of the data and now-a-days regulatory bodies are focussing on confirming data integrity and the principle gives them confidence to evaluate any data.


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