Data integrity is vital to success in cGMP manufacturing. Companies can produce safer and higher quality products when they document reliable, accurate data. However, in order to ensure data integrity in your organization, you must first have a good understanding of what data integrity is.
The FDA defines data integrity as “complete, consistent and accurate data,” and uses the acronym ALCOA plus ER to define its characteristics:
Attributable – Who performed the action? When was the action preformed?
Data must be properly documented with the ability to associate the individual who completed or observed a task with a descriptive account of the action that was performed.
Legible – Is the data permanent and readable?
Numbers and letters must be entered clearly so that they are identifiable; even over time.
Contemporaneous – Was the data recorded at the exact time of the activity?
Data recording and signatures must be completed at the time the activity is executed or observed, otherwise it can be detrimental to the accuracy of your data.
Original – Is the documentation an original or a true copy?
You must have the original record, or a true copy of the original record. For example, you cannot note the data on a piece of paper and enter it into your system at a later time. The documentation in the system would not be the original data in this instance. Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original data, which includes associated metadata and the static or dynamic nature of the original records.
Accurate – Are there errors in the documentation? Do all edits have appropriate comments associated with them?
Editing without amendments can jeopardize your organization’s data. Data cannot be altered or skewed to avoid deviation by any means.
Enduring – Will the data last over time?
More specific to electronic data, data entries must be able to withstand time. For instance, even with changes in technology, your data must be preserved in a form that will advance along with technology.
Retrievable – Is the data easily accessible? Will it remain easily accessible over time?
Also specific to electronic data, you must be able to retrieve your data even if technologies advance.
With a complete understanding of data integrity, and the commitment to adhere to the proposed guidelines, your organization will be able to ensure safer and more reliable products are put on the market.