Pda Technical Report 80 Link

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:

Frameworks for auditing electronic and paper records to ensure the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus complete, consistent, enduring, and available) are met. pda technical report 80

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. PDA TR 80 moves away from a "one-size-fits-all"

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). pda technical report 80