Independent and not affiliated with the FDA, MHRA, ISPE, PDA, or any agency. Get the appgoutham@madhadi.com
madhadi.comData Integrity & GxP Quality
Browse all topics → Articles Templates & Procedures Learning paths GlossaryScenariosToolsRegulatory ReferencesLearning PathsTopics About Start here
Form Plug-and-play starting point Sterility & Microbiology

Form: Microbial Identification Record

A plug-and-play controlled record for a single microbial identification: isolate source, purity, Gram stain, MALDI-TOF score and library version, sequencing or strain-typing escalation, final identification and level, with field definitions and a filled specimen.

Document type: Form

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 controlled record for one microbial identification. It captures the raw result, the confidence, the library version, and any escalation, so the call is attributable, reproducible, and defensible. Replace every <<FILL: ...>> placeholder, attach it to the source sample or investigation, and route it through your normal review. Field definitions and a filled specimen follow. This content is educational reference, not legal or regulatory advice.

Record header

FieldFormatRequiredWhoWhen
Record number<<FILL: ID-ID>>YesAnalystAt start
Isolate IDtextYesAnalystAt start
Source sample / event referencetextYesAnalystAt start
Area and gradetextYesAnalystAt start
Sample typetextYesAnalystAt start
Date recovereddateYesAnalystAt start

1. Purity and first read

FieldEntry
Pure culture confirmedYes / No (if No, subculture and re-isolate)
Colony morphology<<FILL>>
Cell morphology<<FILL>>
Gram reaction<<FILL: Gram-positive / negative; cocci / rods; yeast / mold>>

2. Primary identification (MALDI-TOF)

FieldEntry
PreparationDirect smear / formic-acid extraction
Score<<FILL>>
Call at that score<<FILL: species / genus / no reliable ID>>
Organism called<<FILL>>
Library / database version<<FILL>>
Re-prep / re-run performedYes / No, <<FILL: result>>

3. Escalation (if required)

FieldEntry
Escalation trigger<<FILL: below cutoff / poorly represented / challenged in investigation>>
Method<<FILL: 16S / ITS / D2 sequencing / strain typing>>
Database and percent identity<<FILL>>
Strain-typing result (if any)<<FILL: same strain / different strain>>

4. Final result

FieldEntry
Final identification<<FILL>>
Level achievedGenus / Species / Strain
Level required for this situation<<FILL>>
Level requirement metYes / No
Objectionable-organism assessment neededYes / No (route to the assessment form)

5. Records and review

FieldEntry
Isolate retainedYes / No, location <<FILL>>
Analyst (name, signature, date)<<FILL>>
Reviewer (name, signature, date)<<FILL>>

Field definitions

  • Pure culture confirmed: identification of a mixed culture is invalid; confirm purity first.
  • Score: the MALDI confidence value; compare to the cutoffs defined in the governing SOP, not to a personal judgment.
  • Library / database version: records which reference produced the call so it can be reproduced; the library is a controlled record changed under change control.
  • Level required for this situation: from the risk-based rule (species for Grade A/B and investigations; genus often acceptable for routine lower-grade trending).

Retention

Retain with the source sample record or investigation for not less than <<FILL: retention period>>. Retain the physical isolate at least until any related investigation closes; you cannot strain-type a plate you threw away.


Filled specimen

The following shows the record completed for an example Grade B active-air recovery during an excursion. Numbers are illustrative.

Record: ID-2026-0771. Isolate: ISO-2026-0512. Source: EM excursion DEV-2026-0140. Area/grade: Grade B, active air. Sample type: active air, 1 m3. Recovered: 09 May 2026.

StepEntry
Pure cultureYes
Gram reactionGram-positive cocci in tetrads
MALDI prep / score / callFormic-acid extraction; score above species cutoff; Micrococcus luteus
Library versionLIB-v12.3
EscalationNone required (clear species score, not challenged)
Final ID / levelMicrococcus luteus, species
Level required / metSpecies (Grade B recovery, excursion) / Yes
Objectionable assessmentNot classically objectionable; assessment recorded in the investigation
Isolate retainedYes, freezer rack B-12
Analyst / reviewerT. Lin / S. Marsh, 10 May 2026

The species-level call on a Grade B excursion isolate let the investigation conclude it was a transient human-associated organism rather than a waterborne Gram-negative or a spore-former, which directed the root cause and disposition. The isolate was retained in case the trend later required strain comparison.

Common inspection findings this record prevents

  • A call recorded with no score and no library version, so it cannot be reproduced.
  • Genus recorded where the situation required species, with no escalation.
  • Identification of a mixed culture with no purity confirmation.
  • Isolate discarded before the related investigation closed.

How to adapt this form

  1. Set your record numbering and link it to the sample and investigation systems.
  2. Make the library-version and score fields mandatory in your electronic or paper form.
  3. Make the “level requirement met” answer a gate: a No must force escalation, not a sign-off.
  4. Confirm the retention period and isolate-retention rule against your schedule.
Use madhadi.com as an app Full screen, works offline, one tap from your home screen.