Digitize GMP operations from end to end

Paper batch records, sampling logs, and cleaning sheets can delay release and increase errors. Smart-MES streamlines these processes with guided digital workflows, covering material receipt through batch release for cell and gene therapy, CDMOs, and GMP facilities.

Right-first-time execution

Guided workflows minimize errors and ensure GMP compliance at every stage, from material receipt to batch release.

Built-in compliance

Designed to comply with 21 CFR Part 11 and EU Annex 11, incorporating audit trails, e-signatures, and data integrity checks.

Real-time visibility

Monitor operations, review completed records, and ensure production and QA remain aligned on any device.
Batch record BR-2311
Step 7 of 12, final formulation
In progress
Add cryoprotectant to the cell suspension at a 1:1 ratio, then record volumes and bag weight.
  • Cell suspension volumeSpec 45.0 to 50.0 mL46.0 mLIn spec
  • Cryoprotectant volumeCalculated at 1:146.0 mLCalculated
  • Room temperatureSpec 18.0 to 22.0 °C19.6 °CIn spec
  • Final bag weightSpec 85.0 to 95.0 g51.8 gOut of spec
Step cannot be signed until the value is corrected or a deviation is recorded.
Every entry is time-stamped, e-signed, and logged to the audit trail

Illustrative example

How it works

Plan once in the back office. Execute on the floor in the companion app. Review and report without chasing paper.

  1. Masterplan

    Build versioned blueprints for each process, room, and client, with frequencies and assignees.

  2. Schedule and assign

    Work is scheduled automatically from the masterplan and assigned to operators, teams, or roles.

  3. Execute

    Operators follow interactive instructions on the companion app, with data checks and e-signatures at each step.

  4. Review and approve

    Review by exception and approve records remotely from the back office.

  5. Report and trend

    Generate reports and trend analyses in a click, for any room, batch, or period.

Connected modules for complete control

Start with the module your operation needs most and add the rest on the same platform.

Electronic batch records

Interactive work instructions include built-in data integrity checks, calculation tools, and smart data collection, stopping errors before they happen.

Environmental monitoring

Master sampling plans, automatic out-of-specification alerts, and review-by-exception tools help you detect contamination faster.

Cleanroom cleaning

Map-based work orders, versioned masterplans, and e-signed tasks standardize cleaning and keep every record audit-ready.

Cleanroom testing

Guided testing and automated data capture keep cleanrooms within specification.

Sample tracking

Know which samples need to be analyzed, and when, across every room and batch.

Extensions

Add capabilities as your operation grows:
inventory management, equipment management, training management, and device integration.

Materials and equipment, managed in the same system

Extensions connect what goes into a batch and what it runs on to the records that prove it.

Material management

Track every material from receipt to consumption, with release controls before anything reaches production.
  • Material reception and release, with reception controls
  • Storage locations, positions, and picklists
  • Stock level monitoring and reconciliation
  • Purchase orders sent straight to suppliers
  • Material usage captured from production processes

Equipment management

Keep equipment, rooms, and buildings qualified, with interventions planned and recorded like any other GMP process.
  • Equipment classes, types, and operational status
  • Scheduled interventions executed on the companion app
  • A pass or fail result recorded for every intervention
  • In-service checks before equipment is released for use
  • Expiring interventions that take equipment out of service automatically

Proven impact in the first year

Results Title21 clients measured after moving each operation from paper to Smart-MES.

Electronic batch records

90%faster batch release
81%less documentation time
65%fewer errors

Average first-year results reported by Title21 clients.

Environmental monitoring

78%less documentation time
71%higher productivity
1,722working hours saved

A two-operator team in a single cleanroom, one year after go-live.

Cleanroom cleaning

2,080working hours saved
43%less documentation time
39%less travel time

A single site with 15 cleaners, one year after go-live.

Source: Title21 client internal audits, one year after implementation. Batch record figures are client averages; environmental monitoring and cleaning figures are from single client sites.

Engineered for GMP, built for growth

A process builder lets your team define the records, processes, masterplans, and reports your operation uses. Every definition is versioned to keep changes controlled as processes evolve.

Back office

Plan, schedule, review, approve, and report from any browser.

Companion app

Execute batch records, sampling, cleaning, and interventions on a tablet at the point of work.

Platform foundations

  • Modular, cloud-based architecture
  • Integration through APIs and OPC
  • Real-time collaboration between Manufacturing, Quality, and IT
  • Always validated, always audit-ready
21 CFR Part 11EU GMP Annex 11

Solutions Overview

Smart-MES at a glance

Download our two-page guide to Smart-MES modules, compliance features, and the results clients have measured.

Complete the form to download.

See Smart-MES run one of your batches.

Bring a batch record, a sampling plan, or a cleaning schedule. We will show you how it runs digitally, from masterplan to release.

Schedule a demo
Contact sales