This is a ready-to-use form for recording an instrument classification decision under USP General Chapter <1058>. Classification is a documented decision, not an opinion, and this form is the record an auditor asks for when they want to see why a given instrument carries the qualification burden it does. Replace every <<FILL: ...>> placeholder with your specifics and route the completed form through your normal review and approval. A worked filled specimen follows. Verify cited regulations against the current source. This is general guidance to adapt, not regulatory advice.
Header
| Field | Entry |
|---|---|
| Instrument / asset ID | <<FILL>> |
| Instrument type and model | <<FILL>> |
| Location / laboratory | <<FILL>> |
| Intended use (methods and decisions it supports) | <<FILL: be specific, e.g. related-substances by gradient HPLC feeding release>> |
| Classification date | <<FILL: YYYY-MM-DD>> |
| Classified by | <<FILL: name, role>> |
Classification questions
Answer in order. The first Yes that lands the instrument in a group sets the group, subject to the intended-use confirmation at the end.
| # | Question | Answer | Notes |
|---|---|---|---|
| Q1 | Does the instrument produce a measurement or result that feeds a GxP decision? | <<FILL: Yes/No>> | If No, it is Group A |
| Q2 | Does software acquire, process, or store that result such that you would need it to reproduce or defend the result? | <<FILL: Yes/No>> | If No (and Q1 Yes), it is Group B |
| Q3 | Is software integral to the measurement (acquisition, integration, processing, or storage of the record)? | <<FILL: Yes/No>> | If Yes, it is Group C |
| Q4 | Confirm against intended use: could the same hardware be used a more demanding way (kinetic, curve-fit, networked storage)? | <<FILL: Yes/No>> | If Yes, classify against the more demanding use in use |
Determination
| Field | Entry |
|---|---|
| Assigned group | <<FILL: A / B / C>> |
| Rationale (why this group for this intended use) | <<FILL>> |
| Qualification scope this drives | <<FILL: e.g. Group A conformance check; Group B IQ/OQ + calibration; Group C full IQ/OQ/PQ + CSV>> |
| Part 11 / Annex 11 features to assess (if any) | <<FILL: e.g. USB export, data logger, none>> |
| Related qualification protocol references | <<FILL: DQ/IQ/OQ/PQ doc numbers>> |
Field definitions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Instrument / asset ID | text | Yes | Instrument owner | At classification |
| Intended use | text | Yes | Instrument owner | At classification |
| Q1 to Q4 answers | Yes/No + notes | Yes | Instrument owner | At classification |
| Assigned group | A/B/C | Yes | Instrument owner | At classification |
| Rationale | text | Yes | Instrument owner | At classification |
| Reviewer / approver (QA) | signature, date | Yes | QA | At approval |
Approval
| Role | Name | Signature | Date |
|---|---|---|---|
| Classified by (instrument owner) | <<FILL>> | ||
| Reviewed / approved by (QA) | <<FILL>> |
Reclassify and re-approve whenever intended use changes, because a wider or tighter use can move the group and can invalidate the basis of the existing qualification.
Filled specimen
Illustrative example, values invented.
| Field | Entry |
|---|---|
| Instrument / asset ID | LAB-0233 |
| Instrument type and model | UV/Vis spectrophotometer, benchtop, with local PC software |
| Location / laboratory | QC chemistry |
| Intended use | Content-uniformity absorbance readings at a single wavelength, software acquires and stores the spectrum, result feeds release |
| Classification date | 2026-07-03 |
| Classified by | A. Rao, QC analyst |
Questions: Q1 Yes (absorbance result feeds release). Q2 Yes (software acquires, processes, and stores the spectrum; the stored spectrum is needed to defend the result). Q3 Yes (software integral). Q4 Yes (unit is networked and stores records).
Determination: Group C. Rationale: although the read is a single wavelength, the software acquires, processes, and stores the spectrum and result, and USP <1058> lists UV/Vis among Group C examples; the stored electronic record is part of the measurement system. Qualification scope: full IQ/OQ/PQ plus computer system validation, audit trail verification, individual accounts, raw data retention. Part 11 features to assess: audit trail, access control, electronic records storage. Related protocols: IQ-0233, OQ-0233, PQ-0233.
Approval: Classified by A. Rao 2026-07-03; reviewed and approved by QA (M. Chen) 2026-07-04.
A contrasting note: a stripped-down UV/Vis with only a digital readout and manual transcription of a single number, no software storing the spectrum, could be justified as Group B on this same form, with the rationale recorded. The form is where that justified deviation from the default lives.