Short FDA inspection preparation guides
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Laboratories · Computerized systems
Interrupted laboratory runs: distinguish recovery from a new analysis
Use an invented interruption to examine what the system retained and what the analyst did next. Distinguish resuming work, restarting a run and repeating analysis; avoid assuming that a recovered screen proves the original evidence is complete.
Sign in to read →Laboratories · Computerized systems
Instrument clocks: reconstruct a laboratory event timeline
A cross-system timeline can be difficult to explain when instrument, workstation and laboratory records use different time conventions. Practice reconciling those conventions without silently correcting original records or assuming an offset is harmless.
Sign in to read →Laboratories · Computerized systems
Chromatography reprocessing: explain why the reported result changed
Rehearse an explanation of a changed processing decision using a permitted training dataset. Keep original acquisition evidence, processing choices and review decisions distinguishable. This exercise does not prescribe integration settings or imply that every change is inappropriate.
Sign in to read →Contract laboratories · Computerized systems
Laboratory information systems: trace a transferred result
Follow a training result from its source through interface transfer, review, reporting, and retrieval. Determine applicable record requirements and intended use before assigning a validation approach.
Sign in to read →In vitro diagnostics · Computerized systems
Electronic records: trace access, change, and review
Follow the electronic record through creation, authorized use, changes, retention, and retrieval. Establish which regulatory requirements apply to the record before making a Part 11 applicability claim.
Sign in to read →Medical devices · Computerized systems
Device software assurance: begin with intended use and risk
FDA’s February 2026 final software assurance guidance addresses device production and quality management system software. Start with the function’s intended use and the consequence of failure before choosing evidence.
Sign in to read →Laboratories · Computerized systems
Laboratory spreadsheets: know the calculation and the controls
Identify intended use, inputs, formulas, outputs, access, and version control. The cited software assurance guidance concerns device production and quality software; its scope should not be silently extended to every laboratory.
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