Warning Letters Instructive on Documentation

Five FDA drug company 2026 Warning Letters should be studied by other manufacturers who want to learn more about the agency’s position on documentation defensibility, according to a Quality Digest online post. The post says that in each of the five letters, that were issued within seven weeks, a record that would have settled FDA’s question “either never existed or could be changed by the person it implicated.”

The post includes these five steps to documentation defensibility:

• map spreadsheet exposure to see which spreadsheets record, calculate, or report quality-critical data and flag those that allow unrestricted editing, have no version control, or are the only record of a result;
• ask whether each control is procedural or technical;
• treat artificial intelligence output as a draft that leads of documented human review;
• look at discarded data since it is still data and an investigator can ask where it went; and
• reconstruct one data point end-to-end, using only what the company system produces, to find any gaps before FDA does.

“None of the firms in these letters set out to build an indefensible record system,” the post concludes. “They inherited one, a workbook and a logbook at a time, and it held up until the day that someone asked to see the version that existed on a Wednesday in August.”