Title21 MES digitizes GMP operations to eliminate manual work, accelerate batch release, and ensure compliance across every site. From batch records to environmental monitoring, it unites people, equipment, and data in one connected platform for complete manufacturing control.

Digitize GMP Operations from End-to-End

Right-First-Time Execution

Guided workflows minimize errors and maintain GMP compliance from material receipt through batch release.

Built-In Compliance

21 CFR Part 11 and EU Annex 11 compliant by design, with built-in validation, audit trails, e-signatures, and data integrity.

Real-Time Visibility

Monitor operations, review records instantly, and access insights on any device to keep teams aligned.

Proven Impact

Organizations leveraging Title21 MES have achieved measurable efficiency gains:

81%

Faster documentation time.

65%

Fewer manual errors.

40%

Higher productivity across production and QA teams.

Connected Modules for Complete Control

Electronic Batch Records (eBR)

Streamline process documentation and approvals with interactive, step-by-step workflows.

Environmental Monitoring (EM)

Automate sampling, trending, and deviation alerts to maintain controlled environments.

Sample Tracking & Testing

Coordinate testing activities and approvals with full traceability.

Cleanroom Cleaning

Centralize all cleaning tasks to plan, including cleaning agent rotations.

Cleanroom Testing

Keep track of only one plan to know which samples to pull.

Available Extensions

Inventory Management

Track stock, expirations, and material movement in real time to keep production continuous.

Equipment Management

Know when to maintain your devices from one central location.

Device Integration

Centralize all device data on and operate it from one platform.

Free White Paper

Interoperability Unlocks the Potential of Digitalization

Lack of interoperability in healthcare creates communication silos, increasing errors and delaying treatment, ultimately harming patient outcomes. The future depends on seamless information sharing and patient-centric care. Download our free white paper to learn how interoperability can transform healthcare.

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