A quotation says “GLP compliant”, “USB logging” and “password protected”. Those phrases may describe useful features, but they do not explain whether your lab can reconstruct a changed record, preserve the original information or review the relevant history.

This procurement checklist helps Indian QC laboratories turn broad feature descriptions into testable requirements. Start with the records your method and quality system need. Then check where each function resides, what is included in the quotation and what evidence supports it.

GLP data, logs, permissions and audit trails

On laboratory meters, GLP is often the manufacturer’s name for calibration-related information. Check the manual’s definition. Saved measurement data and access permissions address other parts of the workflow. The table below separates the questions each function can answer.

The FDA drug-CGMP data-integrity guidance describes an audit trail as a protected, automatically generated, time-associated history that enables reconstruction of electronic-record events. A list of saved pH readings is not, by itself, that change history. Record types and applicable controls need to be evaluated in the context of the actual workflow.

Check the complete system, not just the meter

Map the route from measurement to the record that your lab retains and reviews. A standalone meter, a PC connection and a centrally managed software system can place responsibilities in different locations. Ask which component stores the original result, calibration association, event history and review decision.

For each hand-off, identify what transfers and what stays behind. A CSV containing results may omit calibration metadata or event history. A PDF may be useful for reading, while another record carries additional context. Check the actual files, their links and the controls used after export.

FDA’s guidance, question 10 specifically recognises that some pH meters can create a paper printout or static record as the original record. It also distinguishes that situation from instruments whose dynamic electronic data cannot be fully preserved by a printout. Decide the required record format for your actual system; do not assume every pH workflow requires the same architecture.

Eight questions for your procurement checklist

1. Which record fields are actually retained?

Request an example measurement record and calibration report from the proposed configuration. Check sample ID, meter/electrode identity, units, temperature, analyst and calibration reference where required. Find out whether several readings can be linked to the calibration that supported them.

2. Which events does the audit function capture?

List the events important to your workflow: creation, modification or deletion of records; recalibration; method/profile changes; user-permission changes; and clock changes. Confirm the documented coverage for the exact version. A security-event list may have a different scope from a data-change history.

3. What detail does each event contain?

Inspect a real example, not just a menu screenshot. Check user identity, timestamp, affected record and action. Where your requirement calls for previous/new values or a reason for change, confirm those fields and their links. Identify actions that are blocked instead of being allowed and recorded.

4. Who can change the system and its records?

Specify analyst, reviewer and administrator tasks. Check which roles can alter methods, clear memory, change time settings or manage accounts. Confirm how the history itself is protected and who can view or export it. Evaluate unique-user identification rather than relying on one shared instrument password.

5. Can the retained records be reviewed together?

Check how a reviewer opens the result, associated calibration and relevant event history. Ask for filtering by record, time or user if the workflow needs it. Establish how the review outcome is recorded. An event list that exists but cannot be linked to the record can make review difficult.

6. What survives export, backup and retrieval?

Check the proposed formats, metadata and required reader software. Identify where controlled copies are stored, how they are backed up and how a selected record is restored. Confirm capacity and overwrite behaviour before memory fills. Distinguish an exported file from the complete retention and recovery process.

7. Which software, licences and services are included?

Record the meter model, firmware, software product/version, required modules, instrument licences and interfaces. Identify optional items in the quote. Include installation, configuration, training and the agreed validation or qualification support. Confirm who maintains the PC/server, permissions, backup and software updates.

8. Which requirements apply to this laboratory?

Have the laboratory’s quality and IT functions define the intended use and required controls. Where applicable, 21 CFR 11.10 addresses validation, complete copies, record protection, authorised access and audit-trail controls for closed electronic systems. It is not a feature label that makes every meter or laboratory workflow compliant. Define the applicable framework before comparing product claims.

What manufacturer examples actually show

Calibration information example: the Hanna HI98194 / HI98195 / HI98196 instruction manual describes GLP information including calibration date/time, buffers, offset and acidic/basic slopes. This demonstrates calibration-record functionality for that documented family; it does not establish every record-control requirement in your specification.

Software-system example: METTLER TOLEDO’s pH with LabX documentation describes an audit-trail function covering relevant actions at the instrument or PC and central data management. That illustrates why the connected software is part of the configuration assessment. Confirm supported instruments, versions and the licensed functions in the actual offer.

Use these as examples of documentation to examine, not a brand ranking or a statement that either configuration fits every lab. Do not transfer a feature from a newer manual, another model or an optional software package into the quotation without confirmation.

A practical evaluation test

Use an approved demonstration or test environment with dummy records. Agree the expected behaviour in advance. This test plan is an evaluation aid; it is not evidence that a particular product has passed.

Record what happened, the configuration used and any gap. If a function needs another module, changed setup or different software, update the offer and repeat the relevant test. Keep unresolved requirements visible in the comparison; a successful data transfer does not close every record-control question.

Copyable RFQ requirement

Use the following paragraph in your enquiry, then attach the evidence matrix below.

Make the purchase decision with evidence

Compare complete configurations, not the number of feature words on a brochure. Keep one row per requirement with the needed behaviour, supplier response, configuration, evidence reference and unresolved gap. Confirm essential requirements before choosing the setup.

For a shared QC laboratory, assign responsibility for the record system as well as the instrument. Decide who reviews the records, manages permissions and maintains retention. The purchase is only one stage of establishing a working measurement-and-review process.

For the measurement setup itself, see our pH meter selection guide. For interpreting calibration output, use the slope and offset guide. A record system still needs suitable buffer documentation and an appropriate calibration procedure.

Frequently asked questions

Sources and technical references

1. Hanna Instruments HI98194 / HI98195 / HI98196 manual: GLP data and logging
2. METTLER TOLEDO: pH with LabX, audit trail and data-management scope
3. FDA: Data Integrity and Compliance With Drug CGMP — Questions and Answers, December 2018
4. eCFR: 21 CFR 11.10 — Controls for closed systems

Prepared 28 October 2026. The eCFR source displayed Title 21 as updated through 23 October 2026 when checked. FDA guidance cited here concerns drug CGMP; evaluate applicability to the actual laboratory. Product features depend on the documented configuration and version. Images are conceptual illustrations.