# Electronic logbooks for GMP cleanrooms, equipment and instruments
QLogix GMP logbooks are electronic logbooks for cleanroom cleaning, equipment use and QC instruments, kept as audited records on the same platform as the quality system. Each entry is made by the person who did the work, stamped with the system time and verified by a second person where the procedure requires it. Entries are never edited: a wrong entry is voided with a reason and stays visible. Every book names the procedure that governs it and the review cycle that procedure sets, daily, weekly or monthly, and each period is reviewed, concluded and approved with electronic signatures.
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## What the module does
- Three kinds of book: the cleanroom cleaning log, the equipment logbook and the QC instrument logbook, each opened with its identifier, location, governing procedure, review cycle and review deadline.
- Cleanroom cleaning logs: routine cleaning, disinfection with the agent class so rotation shows, periodic deep cleans, cleaning after an intervention, spill cleans, room in use and status changes, counted against the cleaning programme the procedure requires.
- Equipment logbooks: use with product, batch, operation, start and end; minor, major and periodic cleaning; set-up and changeover with line clearance; maintenance, calibration, breakdowns and status changes, with clean and dirty hold times as settings.
- Instrument logbooks: analyses with sample IDs, method, analyst and data reference; calibration and performance checks with their result; maintenance, service visits, malfunctions and status changes.
- Entries that record who made them, when the activity happened and when the system took them; an entry later than the book's late-entry limit needs a reason and is flagged at review; second-person verification is never by the author.
- A status board showing which rooms, equipment and instruments are released for use, set by the status-bearing entries; a use recorded while the subject is not released is a major finding.
- Periodic review: the review falls due when the period ends, the period's entries are frozen with a SHA-256 fingerprint, and the system checks late and voided entries, verification, time sequence, failed checks, hold times and the cleaning programme.
- The AI reads the period against the governing procedure and returns findings with the entries they rest on and the questions to ask the area before concluding.
- Review outcomes of no issues, observations noted or deviation required, approved with signatures by an author, reviewer and approver who are different people; overdue reviews raised and escalated in the alert bell.

## How it fits the platform
Logbooks sit beside the LIMS, calibration management and the CMMS on the same audited records and the same hash-chained audit trail. When a review finds a failure that may have affected product or data during GxP operation, the deviation investigation opens from the review in the quality system and links back to it. Review deadlines are watched by the alert rules for the logbooks area, so a review that is due is raised when the period ends and escalated to critical once the deadline passes.
A book that is full, or whose room, equipment or instrument is decommissioned, is closed, and its last period can be reviewed at once. Where earlier periods were not reviewed on time, one review can cover several consecutive periods; the review says so, and that is itself a finding.

## Where people decide
The person who did the work records it, and a second person verifies the cleanings and checks the procedure names. The system runs its GMP checks and the AI reads the period, but the reviewer concludes, and a major finding cannot be concluded as no issues without being addressed. The approver's signature fixes the book as reviewed through the period.

## Where people decide
- Entries are never edited: a wrong entry is voided with the reason, stays visible struck through, and is replaced by a new entry.
- Cleanings and checks the procedure wants confirmed are verified by someone other than the author.
- A major finding cannot be concluded as no issues without being addressed, and the review's author, reviewer and approver are different people.

## Built to
- 21 CFR 211.67 and 211.182 equipment cleaning and use logs
- EU GMP Chapter 4 Documentation (logbooks)
- EU GMP Annex 1 cleaning and disinfection
- 21 CFR Part 11 and EU GMP Annex 11
- MHRA GxP data integrity guidance
- ALCOA+ data integrity principles

## White paper
Lab and plant, connected
LIMS, calibration, logbooks and CMMS on one AI-enabled infrastructure
[Download the white paper](https://qlogix.ai/whitepapers#connected-lab-and-plant)

## 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.
[Ask for a quote](https://qlogix.ai/contact)

## Questions about GMP logbooks

### What is an electronic logbook in GMP?

An electronic logbook is the GMP record of what happened in a room or on a piece of equipment or an instrument (cleaning, use, checks, maintenance, malfunctions and status changes), kept as an audited electronic record instead of a bound paper book. In QLogix each entry is attributed to its author, stamped by the system, verified where the procedure requires it, and reviewed periodically with signatures.

### Can a logbook entry be corrected?

It is never edited. A wrong entry is voided with the reason, stays visible struck through, and a new entry replaces it; the audit trail keeps each step with the name and time.

### How often are logbooks reviewed?

On the cycle the governing procedure sets: daily, weekly (Monday to Sunday) or monthly, with a number of days after the period end by which the review must be approved. The book shows the review as due and then overdue, and the alert bell escalates it once the deadline passes.

### What does the system check at periodic review?

Late and voided entries, entries without second-person verification or verified by their author, entries out of time sequence, uses without an end time, failed checks, and use while the subject was not released. It also checks each cleanroom programme task against its entries, equipment clean and dirty hold times, and instrument analyses after a failed check without a passing one.

### Is the audit trail Part 11 ready?

Logbooks are built to 21 CFR Part 11 and EU GMP Annex 11: entries are attributable and system-stamped, never deleted but voided with a reason, the reviewed entries are frozen with a SHA-256 fingerprint, and reviews are approved with electronic signatures. Every change is kept in the platform's hash-chained audit trail.

### How is it licensed?

Per user per month, on its own or with other modules, ordered by purchase order from the client portal. There is no card payment or self-serve plan.

## Reading
- [Predictive maintenance in GMP: how CMMS, calibration and reliability data decide when equipment is serviced, calibrated and replacedA preventive interval copied from a manual is a guess. The work orders, downtime and calibration results a site already records contain the answer: mean time between failures, avai…](https://qlogix.ai/blog/predictive-maintenance-cmms-calibration-gmp)
- [AI in deviation investigations: faster, more consistent root cause analysisAI is most useful in an investigation at the start, where time is lost: it drafts the problem statement, the containment check, the 5 Whys and a fishbone whose causes are testable …](https://qlogix.ai/blog/ai-deviation-investigation-root-cause-analysis)

## Other modules
- [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)
- [Project managementPrograms and projects on audited records: AI-drafted plans with work breakdown, resources, risks, baseline, critical path and earned value, signed at approval.](https://qlogix.ai/products/project-management)
- [Q Intelligence, Q Agent and agentsAI for pharmaceutical quality: ask across every GxP record with cited sources, draft the next record, and hand tasks to AI agents within approvals you set.](https://qlogix.ai/products/ai-for-pharma-quality)
[All 18 product pages](https://qlogix.ai/products)

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