Common issues related to data integrity

Data integrity is “The maintenance of, and the assurance of the accuracy and consistency of, data over its entire life cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.

Data integrity is the opposite of data corruption, which is a form of data loss
The intent of any data integrity technique is the same: ensure data is recorded exactly as intended … [stored]… and upon later retrieval, ensure the data is the same as it was when it was originally recorded.
In short, data integrity aims to prevent unintentional changes to information
Data integrity is not to be confused with data security [cybersecurity]. — “Data Integrity and Compliance With CGMP Guidance for Industry”, Draft Guidance, April 2016.

Common Issues:

Workflow not validated
Access not properly restricted
Shared login accounts not monitored or controlled
Controls not in place for blank forms
Audit trails not reviewed
Electronic copies not verified
Paper print-outs not tested, but used to make decisions
Electronic signatures not authentic or monitored

New Issues surfacing recently:

Manipulation of date/time stamps to make it appear samples were tested on a different day than they actually were
Failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b))
- Lack of basic controls to prevent changes to electronically stored data
- Audit trails turned off
- No controls to prevent substitution, deletion, or overwriting of data
- Sharing user names and passwords
- QC personnel created unauthorized folders on lab computers without appropriate oversight
- Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data
- Only included the most favorable result obtained from multiple test results without any justification
- Failure to record activities at the time they are performed
- Destruction of original records
- “Rough notes” (unbound, uncontrolled loose paper) used to capture original critical manufacturing data were destroyed after transcription into the batch production records.
- Backdating of production records when personnel were not onsite to perform the activity