Short FDA inspection preparation guides
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Short, focused preparation briefs with source context, records to retrieve, questions to discuss, and a practical exercise. Browse descriptions publicly; create a free account to read the complete briefs.
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Laboratories · Testing & laboratory work
Laboratory analyst handovers: keep unfinished work visible
An unfinished preparation or review can cross a shift boundary. Rehearse a handover that lets the next authorized person understand the actual status from records, including exceptions and work that has not yet been reviewed.
Sign in to read →Laboratories · Validation & qualification
Laboratory service visits: assess the impact on testing
A service visit may change a component, setting or operating condition that matters to the laboratory’s work. Practice explaining the site’s assessment and return-to-use decision rather than treating a closed work order as the entire evidence package.
Sign in to read →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 →Laboratories · Testing & laboratory work
Reference standards: reconcile the certificate, preparation and use
Practice a backward trace from a reported analytical result to the standard actually used. Concentrate on identity and preparation history rather than treating a certificate stored somewhere in the laboratory as the complete explanation.
Sign in to read →Laboratories · Validation & qualification
Calibration records: connect instrument range to actual use
Compare the instrument’s use with its calibration, checks, status, and response to an unacceptable result. A current sticker alone does not explain the suitability of a particular measurement.
Sign in to read →Laboratories · Validation & qualification
Analytical method validation: define the reportable use
Identify the analyte, matrix, range, reportable result, and intended decision before reviewing the method evidence. A method may need a different assessment when its use changes.
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.
Sign in to read →Laboratories · Inspection preparation
Out-of-specification results: preserve the investigation path
Read the chronology from the initial result onward. Separate observations, hypotheses, additional testing, and documented conclusions so that a later passing result does not erase the original question.
Sign in to read →Laboratories · Testing & laboratory work
Chemistry laboratory: connect the result to original data
Select a test and trace standards, sample preparation, instrument records, calculations, and review. A signed certificate is the end of a chain of evidence, not the whole chain.
Sign in to read →Laboratories · Testing & laboratory work
Microbiology laboratory: trace a sample through the bench
Follow one sample from receipt to the reported result. Keep the sample identity, handling, method version, media, observations, calculations, and review connected.
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