One platform across the entire production lifecycle
Retire the paper. Connect the floor.
Manual operations are slow, error-prone and impossible to audit. Smart Factory digitizes every step and links them into one live system of record.
- Paper batch records & handwritten logbooks
- QC results trapped in spreadsheets and email
- Wet-ink signatures and binders for audits
- No real-time view of OEE, yield or bottlenecks
- Recalls mean days of manual batch tracing
- Compliance gaps discovered during inspections
- Electronic Batch Records enforced step-by-step
- QC tests auto-checked against specifications
- Built-in 21 CFR Part 11 electronic signatures
- Live dashboards for production, quality & OEE
- Serial-level genealogy — recall impact in seconds
- Always audit-ready with an immutable trail
A complete, modular MES
Switch on the modules each factory needs. Every one is built for GMP and works together out of the box.
Production & EBR
Electronic batch records with enforced steps, in-line checks and QA sign-off.
Quality Control & QA
Sampling, testing against specs, Pass/Fail/Re-Test, and e-signed batch release.
Weigh & Dispense
Guided dispensing with scale integration, tolerance checks and reconciliation.
Serialization & Traceability
GS1 DataMatrix, aggregation, EPCIS events, verification and recall management.
Materials & Inventory
Receiving, quarantine, lifecycle states, barcoded batches and stock movements.
Equipment & Calibration
Asset registry, calibration schedules, maintenance and OEE analytics.
One digital thread, raw material to released product
Each step hands off automatically to the next, capturing data and signatures as it goes.
Receive
Goods-in with auto-generated barcoded batches into quarantine.
Produce
Dispense and execute electronic batch records on the line.
Test
QC records results, auto-evaluated against specifications.
Release
QA reviews and releases with an electronic signature.
Serialize & ship
Serialize, aggregate and dispatch with full traceability.
What going online actually delivers
Live OEE & yield
Spot downtime and bottlenecks as they happen, not at month-end.
Faster recalls
Trace affected serials and batches instantly instead of over days.
Audit-ready
Every action signed and logged for inspection at any moment.
Duplicate entry
One record flows across departments — no rekeying, fewer errors.
Built for the people who run regulated production
We replaced three binders and two spreadsheets per batch. Release that took two days now happens the same shift.
During our last inspection every record was one click away — signed, timestamped and complete. No scramble.
Serial-level traceability means a recall query that used to take the team a week now returns in seconds.
Computerised systems, covered clause by clause
The operational controls Annex 11 expects from software are built into the platform — and it produces the audit trails, signatures and records your validation package and SOPs point to.
Data
Built-in checks on every electronic exchange — typed validation, scale tolerance and calibration gating, strict factory scoping.
Accuracy checks
Critical manual entries need a second operator: the verifier must differ from the weigher and signs electronically.
Printouts
Clear, printable copies of every batch record, with signatures and their verification state on the page.
Audit trails
System-generated, append-only trail of every change with user, timestamp, before/after values and the reason.
Security
Role-based access per module and factory, failed-login lockout, password aging — and every authorisation change recorded.
Incident management
Deviations and CAPAs with revision-controlled investigations, root cause and effectiveness verification.
Electronic signature
Signatures are timestamped and cryptographically bound to the record's content — tampering after signing fails verification.
Batch release
Release demands an explicit e-signature from an authorised person, recorded on the batch with identity, date and time.
Archiving
Records are retained, never hard-deleted, and content-hash signatures keep archived data verifiable for integrity.
Annex 11 is a lifecycle standard: risk assessments, validation packages, backups and change-control procedures remain your quality team’s responsibility. Smart Factory supplies the enforced controls and inspection-ready evidence they build on.
Bring your factory online
Replace the paper, connect the floor, and make every batch traceable. See how Smart Factory digitizes your operation end to end.