12/13 October 2021
Since data integrity has become a "hot topic" in the pharmaceutical industry, ALCOA+ has been cited as the ultimate reference. Nevertheless, the meaning and consequences of this acronym should be clearly understood, avoiding mistakes and shortcuts. Keep in mind that ALCOA+ criteria like the overall data integrity requirements cover equally paper, electronic as well as hybrid records, the following interpretation should be considered:
Who acquired the data or performed an action and when?
Where - what system, what device, what sensor, etc. - does the data come from?
Can you read and understand the data?
Are data, observations, and activities timely recorded?
For paper records:
For electronic records generated by a computer system the system architecture needs to be accurately reviewed ensuring that the data is effectively timestamped (incl. the time zone as appropriate) at the capture respectively creation time and not after standing in a queue for an undetermined period of time.
This requirement is particularly versatile since it covers various contexts.
For paper records:
For copied electronic data: all essential metadata and the original record format [WHO]
Because "accurate" is a commonly used generic term, it is necessary to address its different meanings within the context of data integrity, in particular: correctness and precision.
Use of accurate (e.g. calibrated) and controlled data sources.
No errors or editing without documented amendments, i.e.:
For paper records, the process to capture the data shall be clearly defined, and the data must be recorded accordingly, incl. expected record format (e.g. date) and precision (e.g. number of decimal places). The unambiguous identification of the data source must be clearly documented. For data recorded using a computer system, the verification executed during the initial qualification and later in case of changes and repair activities must secure that the data is captured from the right source and properly processed (e.g. linearization, normalisation, conversion, etc.).
All data present (no omission, no deletion), incl. initial data, meta-data, etc.
When electronic data shall be printed on paper or as PDF, it is necessary to ensure that the printout contains the complete data with the required accuracy.
All elements of the record sequence of events follow on and are date or time stamped in the expected sequence.
Data must not be recorded on the back of envelopes, sticky notes, etc. but directly on authorised media (see also "original data").
Electronic data must be stored on controlled and robust electronic media; i.e.:
Can the data be accessed for review, audit or inspection over the lifetime of the record? Including after the contract end in case of outsourced activities? Data must be recorded on controlled paper forms resp. on controlled electronic media. Remark:
ALCOA+ criteria shall always be considered context related. Furthermore some "single word" can cover complex reality and interpretation which requires to be taken into account in its full extent. It shall not be forgotten that Data Integrity requirements are as old as the GMP/GxP requirements; consequently GxP compliance cannot be achieved without securing and enforcing Data Integrity. The adequate implementation of the ALCOA+ criteria is the condition for being able to rely on the generated, processed, and reported data.
Author: Yves Samson