Is Security and Audit Trails Enough for Data Integrity?
Many people confuse data integrity with 21 CFR Part 11. In other words, they mistakenly believe that data integrity is a guarantee of reliability for electronic records. The principle of data integrity is equally imposed on both electronic and paper records. Here is a question for the reader.
‘Which is more important to patient safety, tampering with electronic records or tampering with paper records?”
The answer is ‘the same’.
Many companies focus on the reliability of electronic records in their data integrity response. This is why they confuse data integrity with 21 CFR Part 11.
Can data integrity be guaranteed with security and audit trails?
It has been reported that up to 80% of data integrity violations are human error. However, if you listen to many seminars and lectures, most of them are about security measures for computer systems and replacing equipment with audit trails. So, do security and audit trails prevent human error?
The answer is “no.”
To ensure data integrity, it is important to protect original data from any unintended changes to electronic and paper records, whether intentional or accidental.The answer is “no.”To ensure data integrity, it is important to protect original data from any unintended changes to electronic and paper records, whether intentional or accidental.
21 CFR Part 11 not revised!
It is likely that 21 CFR Part 11 will not be revised in the future. The reason is that it is specific to electronic records and, as noted above, does not prevent human error. And 21 CFR Part 11 is all about “how to prevent fraud and how to detect fraud. There should be no fraud. But how many of the records are tampered with by fraud? “Tamper-proof” ≠ “data integrity is guaranteed”. Data integrity must prevent human error, double-check, and guarantee reliability. This will first of all cover 80% of data integrity violations.
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