Guest Author: Heather Longden

Ms. Heather Longden has thirty (30) years of experience in regulatory compliance in the pharmaceutical industry and is an expert in data integrity, data management, 21 CFR Part 11, GxPs, and computer system validation. She is a leader at the GAMP^® Americas Steering Committee and serves on the the ISPE Boston Area Chapter Board and Education Program Committee (EPC).

Reading a newly published FDA Warning letter (1)

“https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nortec-quimica-sa-639894-12082022”

I was surprised and ‘not surprised’ to see ‘analytical worksheets’ mentioned in the midst of some basic electronic data integrity observations.

… the “analytical worksheet forms” used for recording testing results in the quality control (QC) laboratory are not controlled as there was no unique number, signature, or any other traceable element on the forms themselves to identify when or by whom it was issued.

It is not clear or obvious if this observation refers to paper forms or electronic forms, but in fact, it really makes no difference to the Quality Units’ responsibility to review and ‘reconcile’ forms and documents. In this specific example, the inspector was concerned about the correct assignment of ‘Attributability’ or the first A in ALCOA+. This is likely because other observations on electronic laboratory records also suggested issues with attributability. Continue reading “Data Integrity Compliance for Paper Forms and Electronic Data  Created in Regulated Laboratories and Manufacturing – A Review of Two Recent FDA Warning Letters”