Title21

What Title21 does

Title21 Health Solutions (legal entity Title21 Software, Inc.) is a Phoenix, Arizona-based enterprise SaaS provider founded in 2001 and owned by healthcare-focused growth equity firm ARCHIMED. The company serves cell and gene therapy (CGT) manufacturers, blood and marrow transplant programs, blood centers and biobanks, CDMOs, cellular therapy laboratories, and broader life sciences quality operations across North America, Europe, and select international markets (over 100 healthcare sites). Its name derives from Title 21 of the U.S. Code of Federal Regulations, reflecting its origin in FDA-regulated quality management.

The platform is organized as a core-plus-modules architecture: a Cell and Gene Therapy Orchestration Platform that harmonizes EMRs and laboratory systems for end-to-end CGT traceability; a cloud-based (with on-premise option) Manufacturing Execution System with nine modular extensions covering electronic batch records, environmental monitoring, sample tracking, inventory, equipment, training, cleanroom cleaning and testing, and device integration; an Enterprise Quality Management System for SOP, CAPA, training, and document control; Blood and Marrow Transplant software; and post-2026 acquired capabilities (MyCellHub's EU MES and cResults' Smart-QX, Smart-FDA, Smart-AID) that add AI-driven compliance intelligence and QC/QA resource planning. The technology stack is purpose-built for 21 CFR Part 11 and EU Annex 11 compliance, ISO 27001 certified, and GDPR/CCPA compliant, with integrations into HubSpot, Google Analytics, LinkedIn Insight Tag, and a SCIM identity access management bridge.

Title21 monetizes via quote-based enterprise SaaS subscriptions on multi-year contracts, supported by implementation, validation, and professional services revenue. Go-to-market is exclusively direct — enterprise field sales plus inside sales — augmented by industry event presence (Tandem Meetings, Advanced Therapies Week), webinars, an Advisory Council, and an extensive content marketing library. There is no channel partner or reseller model. Customer-reported outcomes include a 67% reduction in staff work time at Memorial Sloan Kettering, 13 hours/week reallocated and 208 days/year saved at ImpactLife, 65-78% reductions in error and documentation time in environmental monitoring, and 81% less documentation time with electronic batch records.

Name

Title21

Legal name

Title21 Software, Inc.

Website

https://title21.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

11–50 employees

Short description

Title21 Health Solutions provides an integrated cloud-based enterprise software platform — spanning cell and gene therapy orchestration, manufacturing execution, quality management, and blood/marrow transplant workflows — to 100+ healthcare providers, CDMOs, blood centers, and biotech manufacturers across North America and Europe.

Ownership category

akta.pro rank

Product category

Life Sciences Enterprise Software

NAICS

Software Publishers (5132), Custom Computer Programming Services (541511), Computer Systems Design and Related Services (54151)

SIC

Services-Prepackaged Software (7372), Services-Computer Programming Services (7371)

akta.pro primary industry

Cell Therapy Manufacturing Platforms & Automation (closed systems, bioreactors, fill-finish) (HLAAABAG)

akta.pro secondary industries

Lab Data Exchange & Interoperability (HL7/FHIR/LDT Results Delivery) (HLACAMAL), Electronic Data Capture (EDC) Platforms (HLACAOAA), Site Data Management Support (EDC/Source/SDV Readiness) (HLAGACAL), Clinical Document & Data Exchange (C-CDA, CCD, Direct Messaging) (HLACABAI)

Keywords

• Cell and gene therapy software
• Manufacturing execution system
• Enterprise quality management
• Blood and marrow transplant software
• Life sciences compliance platform

Headquarters

HQ city

Pleasanton

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Infrastructure, Operations

Revenue model

1. SaaS Platform Subscriptions: Title21 operates as a SaaS provider delivering cloud-based software platforms (MES, EQMS, CGT Orchestration, BMT) on a subscription basis. The company also offers the MES as an on-premise option. Multiple acquisitions (MyCellHub, cResults) expand the integrated platform offering, suggesting a land-and-expand SaaS model targeting life sciences organizations.
2. Platform Licensing and Professional Services: The company provides implementation, training, and support services alongside its software platforms. Services include software validation support, customer onboarding, and advisory council-driven product development feedback loops.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels9 records

Core offering

Title21 Health Solutions provides fully integrated cloud-based enterprise software platforms for cell and gene therapy manufacturers, blood and marrow transplant programs, CDMOs, blood centers, and broader life sciences organizations. The offerings include a Cell and Gene Therapy Orchestration Platform, a Manufacturing Execution System with modular extensions, an Enterprise Quality Management System, and Blood and Marrow Transplant software, all designed to replace paper-based workflows and disconnected systems with regulatory-grade digital workflows compliant with FDA 21 CFR Part 11 and EU Vol 4 Annex 11.

Product overview

Title21 Health Solutions offers an integrated suite of enterprise software solutions for the cell and gene therapy (CGT), biopharmaceutical, blood and marrow transplant, and broader life sciences markets. The portfolio operates as a platform-plus-modules architecture built around four core products: the Cell and Gene Therapy Orchestration Platform (harmonizing EMR and lab systems for end-to-end traceability), the Manufacturing Execution System (MES) with modular extensions covering electronic batch records, environmental monitoring, sample tracking, inventory management, equipment management, device integration, cleanroom cleaning/testing, and training management, the Blood and Marrow Transplant software, and the Enterprise Quality Management System (EQMS). In 2026, Title21 expanded its portfolio through two strategic acquisitions: MyCellHub's cloud-based MES platform for advanced therapy manufacturing (January 2026), and cResults' Smart-QX suite including Smart-FDA (AI-driven FDA compliance intelligence) and Smart-AID (automated batch record review). Together, these products form a unified digital ecosystem connecting clinical programs, manufacturing operations, quality management, and analytics across the therapy lifecycle from bench to bedside.

Differentiator

Problem solved

Functional benefit

Products and services

• Cell and Gene Therapy Orchestration Platform An integrated, pre-defined suite of tools for managing patients, products, facility, staff, and operations across the cell and gene therapy lifecycle. Harmonizes electronic medical records (EMR) and cellular processing laboratory systems, connecting clinical orders, manufacturing workflows, and quality documentation in a unified digital workflow with regulatory-grade traceability.
• Manufacturing Execution System (MES) A cloud-based Manufacturing Execution System platform designed for cell and gene therapy, CDMOs, and GMP facilities. Delivers real-time production monitoring, electronic batch records, and embedded quality management within manufacturing operations.
• Blood and Marrow Transplant (BMT) Software Complete data management tools designed to simplify and streamline blood and marrow transplant program workflows from patient evaluation through product infusion and long-term follow-up.
• Enterprise Quality Management System (EQMS) An enterprise-grade quality management system that automates and streamlines staff training and learning, SOP documentation lifecycle management, CAPA processes, deviation management, and document control for healthcare and life sciences organizations.
• GMP Facilities Services Professional services supporting GMP facility operations, including software implementation, validation, and ongoing operational support for regulated manufacturing environments.
• MyCellHub MES Platform A cloud-based manufacturing execution system (MES) tailored for regulated life science and advanced therapy manufacturing, enabling organizations to move from paper-based processes to 21 CFR Part 11-compliant digital batch records and production workflows.
• Smart-QX Platform A SaaS-based digital performance platform delivering resource planning, automated scheduling, KPI monitoring, cost-of-quality analysis, and operational efficiency management for QC and QA laboratories in life sciences.
• Smart-FDA An AI-driven capability within the Smart-QX platform that leverages natural language processing and compliance intelligence to analyze FDA Form 483 observations, helping organizations strengthen compliance while improving operational efficiency.
• Smart-AID An AI-powered capability within the Smart-QX platform that automates the batch record review process using natural language processing, reducing review cycles from days to minutes.

Quantifiable outcome

• 67% reduction in staff work time vs. manual processes at Memorial Sloan Kettering Cancer Center
• +10 more outcomes

Named customers7 records

Segments7 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

AI capability8 records

Feature9 records

Partnerships

Three partnerships are on record, tiered core.

• cResultscoreTechnology or Integration · 2 June 2026Acquisition: Title21 acquired cResults, a SaaS-based digital performance platform provider for QC and QA laboratories. cResults brings Smart-QX platforms for resource planning, automated scheduling, KPI monitoring, cost-of-quality analysis, and operational efficiency. Smart-FDA uses AI-driven compliance intelligence and NLP to analyze FDA Form 483 observations; Smart-AID reduces batch record review cycles from days to minutes. Founded in 2005 with nearly two decades of domain expertise serving leading life sciences companies.
• MyCellHubcoreTechnology or Integration · 6 January 2026Acquisition: Title21 acquired MyCellHub, a Belgium-based provider of cloud-based MES technology for regulated life science and advanced therapy manufacturing. MyCellHub's platform helps organizations move from paper-based processes to 21 CFR Part 11-compliant digital batch records and production workflows. The acquisition expanded Title21's geographic coverage to include Europe, adding the Belgium-based team.
• Germfree LaboratoriescoreStrategic or Co-development Partner · 20 October 2023Strategic partnership to create a groundbreaking mobile manufacturing platform powered by Title21's digital operating system. Germfree provides cutting-edge cleanroom infrastructure and mobile manufacturing units; Title21 provides the digital OS backbone enabling decentralized cell and gene therapy manufacturing. This collaboration enables therapy production outside traditional centralized facilities, reducing time-to-market and expanding patient access. The partnership targets decentralized and point-of-care manufacturing models aligned with emerging FDA guidance.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• ValGenesis: ValGenesis provides a digital validation and process lifecycle management platform used by life sciences manufacturers to replace paper-based validation, directly overlapping with Title21's electronic batch records, GMP facilities services, and software validation content. Both target regulated cell therapy, CDMO, and biopharma manufacturers.
• MasterControl: MasterControl provides an enterprise quality management system (EQMS) plus manufacturing and document control software for FDA-regulated life sciences organizations, directly overlapping with Title21's EQMS, MES, and electronic batch record offerings. Both vendors target biopharma, cell therapy, and medical device customers with paper-to-digital quality and compliance transformations.
• Kneat: Kneat offers a paperless validation lifecycle management platform for regulated life sciences manufacturers, closely paralleling Title21's software validation, electronic batch records, and GMP compliance capabilities. Both compete for digital transformation mandates at biopharma, cell therapy, and medical device manufacturers under 21 CFR Part 11.
• DotCompliance: DotCompliance delivers a cloud-based QMS platform for life sciences and healthcare, including document control, training, CAPA, and audit management modules that directly overlap with Title21's EQMS offering. Both vendors compete for regulated digital quality transformation budgets at pharma, biotech, and medical device customers.

Emerging players

• Tulip Interfaces: Tulip is a frontline operations / no-code MES platform increasingly adopted by life sciences manufacturers for electronic batch records and regulated production workflows, directly competing with Title21's MES and electronic batch record modules in biopharma and cell therapy manufacturing. Both target paperless, validated digital manufacturing under 21 CFR Part 11.
• Scitara: Scitara provides a laboratory data connectivity and exchange platform purpose-built for life sciences, directly aligning with Title21's device integration, LIMS harmonization, and lab/manufacturing interoperability capabilities. Both target the integration gaps between instruments, LIMS, MES, and QMS in regulated cell therapy and biopharma labs.

Broad incumbents

• BIOVIA (Dassault Systèmes): BIOVIA provides scientific informatics, laboratory, and manufacturing software for life sciences R&D through commercial operations, with QMS, LIMS, and ELN capabilities that overlap with Title21's EQMS, MES, and laboratory data management modules. Both anchor on regulated biopharma and life sciences customers with paper-to-digital transitions.
• Veeva Systems: Veeva is the dominant cloud software provider for the global life sciences industry, with regulated quality, clinical, regulatory, and commercial suites that overlap with Title21's EQMS, clinical data capture, and life sciences manufacturing functionality at the highest end of the market. Both vendors anchor on 21 CFR Part 11 compliance and target biopharma and emerging therapy manufacturers.
• Sparta Systems (TrackWise) — now part of Honeywell: TrackWise (Sparta Systems, now part of Honeywell) is a long-standing enterprise QMS platform used across life sciences manufacturing, overlapping with Title21's EQMS, CAPA, deviation management, and document control modules. Both serve FDA-regulated customers under 21 CFR Part 11, with TrackWise positioned as a broader incumbent and Title21 as a focused cell therapy and biotherapy specialist.

Regional players

• Greenlight Guru: Greenlight Guru is a cloud QMS platform focused on the medical device industry, sharing Title21's emphasis on regulated quality management, document control, and CAPA workflows under 21 CFR Part 11. While Greenlight Guru is concentrated on medical devices and Title21 on cell therapy and biopharma, both compete for regulated quality transformation budgets in adjacent life sciences markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/title21-health-solutions
• Xx.com/Title21Health

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Title21