When data is complete in nature, it means there is no deletion that has taken place from the date of documenting.
In other words, nothing has been removed without proper correction and accompanying documentation of these changes.
This includes any changes that have been made during the life of the data.
Complete & Fully Present
Data needs to be complete and fully present.
All data, including metadata needs to be included and recorded, in the case of computer systems there should be a validated audit trail.
Data Cannot Be Deleted
Data cannot be deleted or withheld from records or review. All data needs to be transparently documented so that it does not give the impression that something is being hidden.
Health authority observations and citations often contain issues described as incomplete records and data.
Warning Letter
Remember the FDA warning letter to Bayer Pharma AG that we discussed in the previous course in this program?
The FDA specifically stated their firm, “failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).”
Incomplete data is something that inspectors are always on the lookout for.