Audit trails, access control & signature binding
Get 1 Month Free Trial on DMS & LMS |
Get 1 Month Free Trial on DMS & LMS |
KOŚA eLog is an electronic logbook software pharmaceutical manufacturers rely on to replace paper equipment use-logs, cleaning records, and shift logs with a configurable, ALCOA+-compliant digital record. As elog software built specifically for GxP operations, it captures the human context — operator observations, exceptions, shift handovers — that automated MES (Manufacturing Execution System) and SCADA platforms were never designed to record.
From illegible paper use-logs to a searchable, audit-ready digital record
Trusted by manufacturing & quality teams in pharma, biotech & medical devices
PharmaCorp
BioGenex
MediLabs
CuraVita
NovaPharm
The problem
Illegible handwriting, missing entries, and unsecured access aren’t just inconvenient — they carry real audit consequences. Before replacing a logbook, it’s worth naming exactly what’s broken, and exactly what a proper elog software platform is built to fix:
Long delays waiting on physical review and approval
Inability to search across logbooks for a specific entry or trend
Manual, time-consuming report generation for audits and management review
Ongoing cost and risk of physical storage and retrieval
Electronic logbook software
Electronic logbook software replaces the paper logbooks and use-logs long used to record equipment status, cleaning, calibration, and shift activity in GxP manufacturing. As elog software, it turns illegible, easily lost paper entries into structured, timestamped digital records attributable to the person who made them and searchable the moment they’re written. Pharmaceutical electronic logbooks exist because paper logs are routinely incomplete or incorrect, and incomplete documentation remains one of the most common findings in an FDA inspection. Good elog software closes that gap by design, not as an afterthought.
Log anything
Equipment use, cleaning, calibration, deviations, shift handovers — one configurable template engine covers all of it.
Legible & compliant
Every entry is attributable, legible, contemporaneous, and traceable — no more illegible handwriting or missing signatures.
Access anywhere
A fast, familiar interface for operators and technicians, accessible from any device on or off the shop floor.
Where eLog fits
Transactional systems are built for execution speed, not human judgment. Electronic logbook software sits above MES and instrumentation to preserve the observational context an inspector expects to see — the layer that captures what happened, not just whether a step passed or failed.
1
Structured, transactional batch data for high-speed automated lines — binary pass/fail workflows.
2
Captures observational data, situational judgment, and exception narratives above both automated and manual activity.
3
Raw data from PLCs, SCADA, and standalone equipment — real-time readings, sensor data, and alarms.
| Activity | MES Focus | Elog Focus |
|---|---|---|
| Cleaning & Clearance | Pass/fail timestamp | Visual observations & specific methods used |
| Utility Monitoring | Automated alarms | Situational narrative of deviations (e.g. HVAC) |
| Shift Transitions | Not applicable | Continuity narrative and institutional knowledge |
| Calibration | Reference date only | Verification logs and manual instrument checks |
Integration & cost of ownership
KOŚA eLog connects to PLCs, SCADA, and standalone instruments through read-only integration — via RS-232/485, Ethernet, OPC, or open API, without touching validated control logic. That means no costly re-validation cycle just to start capturing data, and a materially lower total cost of ownership than a custom point-to-point build:
| Metric | Custom Integration | Kōsa Elog |
|---|---|---|
| Engineering effort | Custom hardware & point integrations | 70–80% fewer engineering hours |
| Deployment timeline | Long MES programs, often years | 2.5x faster go-live, in months |
| Ongoing maintenance | Tightly coupled, high support load | 50–60% less ongoing support |
Coverage
KOŚA eLog consolidates logbook activity across the areas that generate the most paper today, and the most audit findings.
Logbooks are a staple across the organisation. KOŚA eLog software is used daily by Facilities, Lab, and EHS teams as well, anywhere a manual task needs a compliant record.
Cross-functional alignment
Electronic logbooks only replace paper if every function trusts the digital record. This is where good electronic logbook software pharmaceutical teams can rely on across shifts and sites earns its keep. Here’s how KOŚA eLog aligns quality, production, and maintenance:
Move from chasing signatures to reviewing a record that’s already complete.
Give operators one familiar interface for every log they touch in a shift.
Keep calibration and preventive maintenance current without paper reminders.
See logbook health across every site before it becomes an audit finding.
Key capabilities
KOŚA eLog is structured around the capabilities that separate real elogbook software from a digitised spreadsheet — configurability, traceability, and accessibility built into every template.
Configure new logbooks and templates without custom code or IT tickets.
Route entries, reviews, and approvals by role, shift, or site.
Enforce sequence and prerequisite steps before an entry can be closed.
Real-time alerts for overdue entries, exceptions, and approaching thresholds.
Live visibility into logbook status, backlog, and trending exceptions.
Scan equipment or material IDs to pull up the right logbook instantly.
Capture entries without connectivity; sync automatically once back online.
Every entry, edit, and deletion time-stamped and attributable, by design.
Automatically flags discrepancies for QA, cutting manual review to the entries that actually need it.
Hands-free entry capture for operators working in gowned or hands-busy environments.
One-click, audit-ready report exports without manual compilation.
Multiple users can work the same logbook simultaneously, in-document, without version conflicts.
AI capabilities
KOŚA eLog’s AI layer turns weeks of manual configuration into hours, and turns logbook history into a forward-looking signal instead of a static record.
Data integrity & compliance
Logbook entries carry the same regulatory weight as any other GMP record, so KOŚA eLog is engineered against the frameworks inspectors actually check.
21 CFR Part 11
Audit trails, access control & signature binding
EU GMP Annex 11
GMP-regulated manufacturing & quality activities
ALCOA+
Attributable, legible, contemporaneous, original, accurate
cGMP
Minimum requirements for consistent, high-quality production
Implementation
Week 1–2
Identify high-risk paper logs and map documentation gaps by area.
Week 3–5
Logbook templates, checklists & routing configured to your SOPs.
Week 6–8
21 CFR Part 11 validation protocols and operator training on digital capture.
Week 9–10
Phased go-live with MES, QMS & LIMS data sharing switched on.
Get started
Book a 30-minute walkthrough and see how elogbook software, built for pharma, replaces paper use-logs on your floor, tailored to your equipment, your shifts, and your next audit.
21 CFR PART 11 · EU ANNEX 11 · ALCOA+ · cGMP
FAQs