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Log Plug-and-play starting point Equipment Qualification

Log: Equipment Use, Cleaning, and Status Logbook

A plug-and-play equipment logbook capturing use, cleaning, calibration and PM status, and qualified-state at the point of use, with field definitions, completion rules, retention, and a filled sample page.

Document type: Log

Read and copy the template below into your own quality system. It is a generic starting point for your own internal use, provided as is, with no warranty; see the Terms and License. Adopting it does not by itself create compliance.

This is a ready-to-use equipment logbook. It is the contemporaneous record that ties every use of a piece of GxP equipment to a person, a time, a status, and the batch or test it supported, and it is one of the first records an inspector reads because it shows whether the equipment was in a qualified, calibrated, clean state when it produced data. Replace every <<FILL: ...>> placeholder, set your document number, and control it as a bound or paginated GxP record (or configure the equivalent electronic log). A filled sample page follows.

Document control header

FieldEntry
Logbook titleEquipment Use, Cleaning, and Status Logbook
Logbook / document number<<FILL: LOG-ID, e.g. LOG-EQ-HPLC07-01>>
Equipment name and ID<<FILL: NAME / ASSET ID>>
Location<<FILL: room / area>>
Owner<<FILL: department / role>>
Governing SOP<<FILL: SOP-ID for logbook use>>
Retention<<FILL: retention period per schedule>>

How to use this logbook

  • Complete an entry at the time of the activity (contemporaneous), never afterward from memory.
  • Use only your own initials or signature; each user must be on the signature and initials register.
  • Make single-line corrections: strike through once so the original stays legible, write the correct value, initial and date, and add a brief reason. Never obliterate, overwrite, or use correction fluid.
  • Confirm status before use: the equipment must be within calibration and PM, in a qualified state, and clean/ready. If any status is not current, do not use it; quarantine it and raise a deviation.
  • Do not leave blank lines between entries. Mark any genuinely unused field “N/A”.
  • One logbook per equipment item (or a controlled electronic equivalent with the same fields and the same audit trail).

Field definitions

FieldFormatRequiredWho entersWhen
Entry no.Sequential integerYesUserAt each activity
DateDD-MMM-YYYYYesUserAt the activity
Start / end timeHH:MM (state time zone or use controlled system time)YesUserAt start and end of use
ActivityUse / cleaning / maintenance / calibration / idle-checkYesUserAt the activity
Batch / test / study referenceFree text IDYes for use entries; N/A otherwiseUserAt the activity
Material or methodProduct, sample set, or method runYes for use entriesUserAt the activity
Calibration status confirmed currentYes / No (due date)YesUserBefore use
PM status confirmed currentYes / No (due date)YesUserBefore use
Qualified state confirmedYes / NoYesUserBefore use
Cleaning statusCleaned / ready / not cleanedYesUserBefore and after use
Condition / observationsFree text (normal, or note any issue)YesUserAt the activity
Deviation raisedNumber or N/AYesUserIf any status fails or an anomaly occurs
User initials / signaturePer signature registerYesUserAt the activity
Reviewed by (periodic)Initials and dateYesReviewer/QAOn the review cadence

Completion rules and acceptance

An entry is complete and acceptable when: it was made at the time of the activity; calibration, PM, and qualified-state were confirmed current before use; cleaning status is recorded before and after; the batch/test reference ties the use to a specific record; any failed status or anomaly is linked to a deviation; and the entry is initialed by a registered user. A page is acceptable when entries are sequential with no unexplained gaps, corrections follow the single-line rule, and the page has been reviewed on the defined cadence.

Retention and control

Retain the completed logbook for <<FILL: retention period>>, not less than the retention of the data produced on the equipment. Control blank logbooks through document control (issued, numbered, reconciled). When a logbook is full, close it (final review, archive) and issue the next in sequence so the history is continuous across volumes. On equipment retirement, retain the logbook per the decommissioning procedure.

References

21 CFR 211.182 (equipment cleaning and use log), 211.180 and 211.194 (records and retention). EU GMP Chapter 4 (documentation) and Annex 11 (for electronic logs). MHRA GxP Data Integrity Guidance and Definitions; PIC/S PI 041 (contemporaneous, attributable records).

Confirm the current version and clause numbers of each reference before issue.


Filled sample page

The following shows a completed page for an example chromatography system. The company, system, and numbers are illustrative; replace them with your own.

Equipment: HPLC-07, Room 2-114, QC. Calibration due 30-Sep-2026, PM due 15-Nov-2026.

EntryDateStart / endActivityBatch / testMethodCal currentPM currentQualifiedCleaningObservationsDeviationInitialsReviewed
04112-Jun-202608:10 / 11:25UseAssay ASY-2206-018METH-ASY-11YesYesYesReady before; cleaned afterSystem suitability passedN/AAPRG 30-Jun
04212-Jun-202613:00 / 13:20CleaningN/AN/AYesYesYesCleanedFlush per SOPN/AAPRG 30-Jun
04313-Jun-202609:05 / 12:40UseDissolution DIS-2206-006METH-DIS-04YesYesYesReady before; cleaned afterBack-pressure slightly high, within rangeN/ALMRG 30-Jun
04415-Jun-202608:30 / 08:45Idle-checkN/AN/AYesYesYesReadyNot used since entry 043; status confirmedN/AAPRG 30-Jun

Entry 043 shows the value of the observations field: a rising back-pressure noted while still in range is the early signal that leads to a column change before it becomes an out-of-specification result. The periodic review initials in the last column are the evidence that someone independent reads the log, which is what turns a logbook from a formality into a control.

Common inspection findings this log prevents

  • Equipment used while calibration or PM was overdue, with nothing in the record showing status was checked.
  • A logbook filled in after the fact, so it is not contemporaneous and cannot be relied on.
  • Results produced on equipment with no record it was in a clean, qualified state at the time.
  • Corrections made by overwriting or with correction fluid, destroying the original entry.
  • Blank lines, gaps in the sequence, or missing initials that break the continuous history.
  • A logbook nobody reviews, so an early warning noted in the observations column is never acted on.

How to adapt this log

  1. Set your logbook number, equipment ID, governing SOP, and retention in the header.
  2. Add or remove columns to match the equipment: a chamber log needs a mapping and monitoring column, a sterilizer needs a cycle number, a balance may not need a method field.
  3. If you use an electronic logbook, configure the same fields with a compliant audit trail and keep the completion rules; the review-cadence and status-before-use checks do not change.
  4. Point the deviation column and the governing SOP to your real procedures.
  5. Confirm every regulation in the references against the current published version before issue.
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