The Laboratory File and What Lives In It

Part of Clinical Laboratory (LAB) Training: Inspection Readiness for the Laboratory.

About 2 minutes. Free, in your language, no account needed.

One place where the study's laboratory record lives

Scattered records are the most common readiness problem. Nothing is missing, and nothing can be found.

The laboratory manual, current version, plus superseded versions with their dates.

Delegation and training records for everyone who touched study samples.

Normal ranges and accreditation, current and covering the study period.

Equipment records. Calibration and maintenance for every instrument used.

Temperature monitoring records, including alarm tests and any excursions.

Sample logs. Receipt, processing, aliquoting, storage location.

Shipping records. Manifests, airway bills, logger data, receipt confirmations.

Deviations, with assessments and corrective actions.

When the manual is amended, the old version is retained with the dates it was effective.

Work done in March has to be judged against the manual that applied in March. Without the old version, that is impossible to demonstrate.

A file assembled before a monitoring visit will have gaps, because the memory of what happened has faded.

File as you go. It is less work in total and the records are better.

Logger data, instrument outputs and laboratory systems are part of the file even when they are not on paper.

Know how to retrieve them and confirm you still can. A system that was replaced last year may hold data nobody can now access.

Study records are kept for long periods, often decades. Storage has to be secure, legible and retrievable for that whole time.

Thermal paper fades. Make durable copies of anything printed on it.

Somebody who has never been in your laboratory should be able to answer a question about a sample from the file alone.

If they need you in the room, the file is not finished.