Electronic Logbook

• Errors in hand entries

  Wrong batch numbers, missed times and illegible lines. New staff who never learnt the local habits make it worse.

• The same details, written again

  Product, batch, test number and start time copied into every book, by hand, for every activity.

• Issuing books through QA

  Each new or full book needs QA to issue it. Issuing across every department at once is a logistics exercise.

• The year-end changeover

  Every logbook is closed, archived and replaced in the same few days. Pages get missed and books go out late.

• Slow to look back

  Once a book goes to the archive, finding a past entry means a request, a search and a wait.

• Books that go missing

  A misplaced book is time lost searching, and potentially a gap in GMP evidence you cannot fill.

• Wear, damage and storage

  Paper tears, fades and gets wet. Archiving it properly for years takes shelves, rooms and discipline.

• QA cannot see it live

  Quality only sees an entry when someone brings the book. Problems surface late, and inspectors wait.

• Nothing happens off the record

  Every entry, edit and deletion attempt is kept with who, when and why. The audit trail starts with the first entry, not after go-live.

• Part 11 and Annex 11 by design

  The electronic records and signature controls both frameworks expect are in the product, not bolted on in a validation project.

• Signatures that mean something

  Critical approvals need a fresh authentication. Each signature is bound to its record and states what it means: done, reviewed or approved.

• Scanning tag…

  QR and barcode scanning

  Scan an instrument or equipment QR code, a room sign or a material label and the right logbook opens with its details filled.

• 1. Clean
  2. Verify
  3. Start

  Checklists and interlocks

  Steps run in the order your SOP sets. An out-of-sequence action is refused, not just discouraged.

• No signal · shielded zone

  0 saved on the device

  Works offline

  Keep logging where there is no signal. Entries are saved on the device and sync the moment it reconnects.

• Live equipment data

  Readings from PLCs, SCADA and instruments land in the entry directly, so nobody copies a number off a display.

• Drag-and-drop builder

  Lay out fields, sections, workflows and approval chains without code, and roll a form out to production, QC and stores.

• Views by role

  Operators, supervisors, QA and engineering each see the entries that matter to them, with the right edit and sign rights.

• Alerts and reminders

  Calibration and maintenance due dates, deviation triggers and overdue reviews reach the right person before they slip.

• Dashboards

  Trends, performance and compliance indicators by equipment, area, shift or period, and a click through to the entry behind each one.

• Voice entry

  Dictate an observation while gowned. Transcription is built for noisy manufacturing areas.

• Audit trail that cannot be edited

  Every action, change, approval and deletion attempt, with the user, the time and the reason. Ready for Part 11 and Annex 11 inspections.

• Reports on schedule

  Reports by role in PDF, CSV or XML, generated on demand or sent on a schedule to QA, production and management.

• E-signature workflows

  Review and approval steps set per log type and per user, each signed with a fresh authentication.

1. Step 1

   Find the risk

   List the paper logs and the older equipment with no digital output. Start where a gap would hurt most in an inspection.

2. Step 2

   Overlay, do not rewire

   Put eLogbook forms on top of what runs today. Read-only connections leave validated PLC and SCADA code untouched.

3. Step 3

   Validate and train

   Run the Part 11 validation with IQ, OQ and PQ documents supplied, and train operators on recording observations digitally.

4. Step 4

   Connect the enterprise

   Link logbook data with MES, ERP, eQMS and LIMS, so reporting draws on one source.

Three steps to digital maturity

1. 1

   Off paper

   Replace paper logs for quick data integrity and audit readiness, without touching validated systems.

2. 2

   One standard

   Use the same templates across shifts, sites and departments, so good practice does not depend on who is on duty.

3. 3

   Full context

   Join logbook data with MES metrics for the complete story of each batch, and the analytics that come with it.

• 21 CFR

  Part 11

  Trustworthy electronic records and signatures, complete audit trails and controlled access.

• 21 CFR

  211.182

  The equipment cleaning and use log the FDA expects for every major piece of equipment, in date and batch order.

• EU GMP

  Annex 11

  Computerised systems in GMP: validation, data integrity, audit trails and signatures.

• EU GMP

  Chapter 4

  Good documentation practice, applied to every logbook page that used to be paper.

• MHRA

  GxP data integrity

  ALCOA+ from the moment of capture to the end of the retention period.

• ISPE

  GAMP 5

  A risk-based validation approach, with the documents to support it.

How we prove it

• What is an electronic logbook used for?

  It replaces the paper books kept beside equipment, rooms and processes. Entries are made on screen, checked as they are made and searchable afterwards, which makes investigations and inspections faster and removes transcription errors.

• What is Quickflow eLogbook?

  A GMP logbook application on the Quickflow platform. It records, tracks and approves operational activity, from equipment use and cleaning to calibration, environmental checks and shift handovers, with data integrity controls on every entry.

• Which records can it hold?

  Equipment usage, cleaning, calibration and maintenance logs; cleanroom and environmental monitoring logs; QC laboratory logs such as reagents, columns and media; production and warehouse logs; and quality logs such as out-of-calibration, extension requests and training attendance.

• Does it meet 21 CFR Part 11 and EU Annex 11?

  Yes. It has an audit trail that cannot be edited, electronic signatures bound to their records, role-based access and validation documents, and it supports the equipment cleaning and use log required by 21 CFR 211.182.

• Can operators record in real time?

  Yes. Entries are time-stamped by the server as they are made, readings can come straight from the equipment, and the app keeps working offline and syncs when the connection returns.

• Will it change our validated equipment or MES?

  No. It connects read-only to PLCs, SCADA and instruments and sits beside your MES, so control logic is never modified and there is no re-validation cycle.

• Does it work across several sites?

  Yes. Templates can be standardised across sites while each site keeps its own records, and QA can see every site from one place.

• Can we use our existing logbook formats?

  Yes. Upload the Word template your SOP already uses and the Digital Scientist proposes the matching electronic form. QA reviews and approves it before it goes live, and every later change is versioned.