Digitize GMP Operations from End-to-End
Title21 Manufacturing 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.
Right-First-Time Execution
Guided workflows minimize errors and maintain GMP compliance from material receipt through batch release.
Real-time Data View
Collaborate on the same batch record, approve the same cleaning record and monitor the same samples.
GMP Compliance by Design
21 CFR Part 11 and EU Annex 11 compliant by design, with built-in validation, audit trails, e-signatures, and data integrity.
Error Warnings
Ensure your team follows the correct steps to enable ‘right-first-time’ manufacturing.
Built in Reviews and Approvals
Records can be electronically signed and have their own built-in audit trail.
Easy IT integration
Use all - or only one - of our modules, while always having access to data via APIs.
One Platform. Built Around Your Facility
Our back office and companion app come standard. Add the pre-configured modules and extensions that support your workflows.
Cleanroom Cleaning
Manage tasks to keep cleanrooms clean.
Cleanroom Testing
Validate that your cleanroom is within specifications.
Electronic Batch Records (eBR)
Track any production process.
Environmental Monitoring (EM)
Organize sample plans and automate trending.
Sample Tracking
Know where your samples are in the testing process.
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 one platform and operate it from there.
Proven Impact
Organizations leveraging Title21 Manufacturing have achieved measurable efficiency gains.
Faster documentation time.
Fewer manual errors.
Higher productivity across production and QA teams.
Title21 Manufacturing for GMP
Solution Overview
Title21 Manufacturing
Download the Title21 Manufacturing Solution Overview to see how Title21 delivers a unified digital manufacturing solution built specifically for cell & gene therapy, CDMOs, and GMP facilities.
Complete the form to download.
See Title21 Manufacturing in Action
Schedule a demo of Title21 Manufacturing and see how teams replace paper, reduce deviations, and gain real-time visibility from batch start to release.