PDA TR 80 moves away from a "one-size-fits-all" audit checklist. Instead, it introduces a risk-based prioritization matrix. Labs are instructed to assess every instrument and process based on two variables:
Regulatory citations for data integrity often center on audit trail neglect . PDA TR 80 dedicates an entire chapter to "Audit Trail Review," distinguishing between two types:
– TR-80 is frequently cited in FDA warning letters and inspection reports, so you can find excerpts there for free. pda technical report 80
This refers to the software settings of your chromatography data system (CDS) or lab instrument. TR 80 provides specific guidance on:
is more than a PDF document; it is a philosophical shift for QC laboratories. It acknowledges that the pressure to release products quickly is the greatest threat to data integrity. By implementing TR 80’s risk-based controls—from "Data Integrity by Design" to rigorous audit trail review—labs transform from data generators into data guardians . PDA TR 80 moves away from a "one-size-fits-all"
– pda.org (search for “Technical Report 80”). Cost: ~$200–$350 USD (member/non-member pricing).
The reviewer must look at the audit trail without knowing the final result (blinded review) to prevent confirmation bias (e.g., ignoring a weird integration because the result passed spec). PDA TR 80 dedicates an entire chapter to
PDA Technical Report 80 is a significant document that has had a profound impact on the pharmaceutical industry, particularly in the areas of parenteral and ophthalmic drug products. The report provides a comprehensive framework for ensuring the sterility of these products, from design and testing to validation and environmental monitoring.
One of the most practical sections of deals with the "hybrid laboratory"—where paper printouts are signed, while raw electronic data exists on a local hard drive.
Since it is copyrighted by , you must obtain it legally:
This includes everything from locked server rooms to policies preventing shared usernames. The report emphasizes that a shared generic login destroys "Attributability" (the "A" in ALCOA).