# Electronic lab notebook (ELN) for the GMP QC laboratory
The QLogix electronic lab notebook (ELN) is the analyst's contemporaneous record of laboratory work, kept on the same audited, signed records as the LIMS and the quality system. Each entry records an analytical run, a solution preparation, a method verification or investigation testing: the effective method from document control, the LIMS samples and tests, every piece of equipment checked for fitness across the LIMS, calibration management and the CMMS, released and in-date reference standards, reagents with lots and expiry, the procedure steps, time-stamped observations that are struck through with a reason but never edited, system suitability, and the results, posted straight to the LIMS samples where the specification judges them. The analyst completes the run; a second person reviews and signs it, and the entry is locked.
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## What the module does
- Five kinds of entry: analytical run, solution or reagent preparation, method verification or transfer, investigation testing, and general entry, each numbered ELN-year-sequence with its analyst, laboratory, purpose and start time.
- The method chosen from the effective controlled documents in document management, with the version in force; a method outside the QMS (a pharmacopoeial chapter, a supplier method) is recorded as a reference.
- The LIMS samples and the tests the run performs on them, linked both ways, so the sample shows its notebook entries.
- Equipment checked for fitness when it is added and again when the run is completed: the LIMS instrument's status and calibration, the calibration record's due state and open out-of-tolerance results, the maintenance asset's status and open work orders. Equipment that is not fit is refused.
- Reference standards from the LIMS, refused unless released and in date; reagents and solutions with grade, supplier, lot and expiry, and how each prepared solution was made.
- Procedure steps marked done or not applicable with a reason; observations, calculations and deviations from the method time-stamped by the server, never edited, struck through by their author with a reason.
- System suitability criteria with their acceptance and results; determinations entered against the sample's tests and posted to the LIMS, where the specification judges them and an out-of-specification result is taken to an investigation.
- Raw data (chromatograms, spectra, printouts, worksheets) attached to the entry and fingerprinted; completion blocked until every step, criterion, result and conclusion is in place; second-person review and approval with electronic signatures.

## How it fits the platform
The ELN sits between document control, the LIMS and the equipment records. The method comes from document management and only its effective version can be followed. Results go to the LIMS sample, which keeps them with the entry's reference, so the reviewer of the sample opens the run behind each result and its raw data. One piece of equipment is known to the LIMS as an instrument, to calibration management as a calibration record and to the CMMS as an asset; the ELN reads all three, and the LIMS instrument can be linked to its calibration record and maintenance asset so the LIMS refuses a result on it while either says it is not fit.
Every connection shows from both sides: the sample lists its notebook entries, the instrument, calibration record and maintenance asset list the runs that used them, a failed or out-of-tolerance calibration lists the runs to assess for impact, and the controlled document lists the runs that followed it.

## Where people decide
The analyst records the work as it is done and completes the run; the system checks the equipment, the standards and the reagents, judges the results against the specification and refuses what does not comply. A reviewer who did not perform the run checks the record against the raw data and signs; QA approves the sample results in the LIMS.

## Where people decide
- Equipment, standards and reagents that are not fit for use, out of date or expired are refused when they are added, and equipment is checked again at completion.
- Observations are never edited: their author strikes them through with a reason, and the original stays legible.
- The run is reviewed and signed by a person who did not perform it; the approval locks the entry.

## Built to
- 21 CFR 211.194 laboratory records
- 21 CFR 211.160 and 211.165 laboratory controls
- 21 CFR Part 11 and EU GMP Annex 11
- EU GMP Chapter 6 Quality Control
- MHRA GxP data integrity guidance
- ALCOA+ data integrity principles

## Licensing
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. Every module writes to the same audited records.
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## Questions about Electronic lab notebook

### Does the ELN replace the LIMS?

No. The LIMS holds the samples, specifications and results that QA approves; the ELN holds how each result was obtained. Results are entered once, in the notebook, and posted to the LIMS sample, where the specification judges them.

### What happens when equipment is out of calibration?

It is refused when the analyst adds it to the run, with the reason from the module that stops it: an overdue or failed calibration, an undecided out-of-tolerance result, an asset under maintenance or out of service. If it fails during the run, the check at completion shows it and the analyst records a deviation from the method.

### Can an observation be corrected?

It is never edited. Its author strikes it through with a reason and records a new one; both stay on the record with their times and names, and the audit trail keeps each step.

### How is it licensed?

Per user per month, on its own or with the LIMS and other modules, ordered by purchase order from the client portal.

## Reading
- [Connecting LIMS to investigations and CAPA: how AI speeds up OOS investigations and strengthens complianceMost OOS investigations lose their first days to gathering: the result, the raw data, the instrument's calibration, the standard's expiry, the analyst's history, the trend. When th…](https://qlogix.ai/blog/lims-investigation-capa-integration-ai)

## Other modules
- [MES (electronic batch records)MES for pharma with electronic batch records: your master batch record, every step signed and verified, review by exception, ERP orders and QA release.](https://qlogix.ai/products/mes-electronic-batch-records)
- [GMP logbooksElectronic logbooks for GMP cleanrooms, equipment and instruments: system-stamped entries, second-person verification, never edited, periodic reviews signed.](https://qlogix.ai/products/gmp-electronic-logbooks)
- [PM LibraryA particulate matter library for fill-finish: defects characterized with images and FTIR, approved by QA, and current kits for inspector and AVI qualification.](https://qlogix.ai/products/pm-library)
- [Calibration managementEvery instrument, tool and gauge: an approved requirement, readings judged by the system and reviewed by a second person, out-of-tolerance impact signed by QA.](https://qlogix.ai/products/calibration-management)
- [CMMSA GMP CMMS on audited records: assets with preventive plans, work orders verified for return to service, and reliability and predicted failures from the history.](https://qlogix.ai/products/cmms)
- [ValidationComputer system validation software built on GAMP 5 and CSA: URS and risk, IQ/OQ/PQ protocols, electronic test execution, a live traceability matrix, signed reports.](https://qlogix.ai/products/computer-system-validation)
[All 18 product pages](https://qlogix.ai/products)

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Source: https://qlogix.ai/products/electronic-lab-notebook
QLogix · contact@qlogix.ai · +17146639012