Data Integrity is the extent to which all data are complete, consistent and accurate throughout the data lifecycle.

• Handwritten entries should be made in a clear, legible, indelible way.
• Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.
• Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.

ALCOA is an acronym representing the following data integrity elements:

• Attributable – Who performed and when?
• Legible – Can it be read? Permanent Record
• Contemporaneous – Recorded at the time the activity was performed
• Original – Original record or certified true copy
• Accurate – Error free

ALCOA +

1. Complete: All data including repeat or reanalysis performed on the sample.
2. Consistent: Consistent application of data time stamps in the expected sequence
3. Enduring: Recorded on controlled worksheets, laboratory notebooks, or electronic media.
4. Available: Available/accessible for review/audit for the lifetime of the record.