ValGenesis
- Company typePrivate
- Founded2005
- HeadquartersFremont, United States
- Headcount501–1,000
- GTM typeB2B
- OfferingSoftware
What ValGenesis does
ValGenesis is a privately held, AI-enabled digital validation lifecycle management company founded in 2005 and headquartered in the San Jose, California area. The company sells an integrated platform called Smart GxP™ to pharmaceutical, biotechnology, medical device, and contract development and manufacturing organizations (CDMOs), reporting that 30 of the top 50 global life sciences companies use its software across more than 40 countries. Its product portfolio is organized into two suites: the Validation Lifecycle Suite (iVal™ for validation authoring and execution, iClean™ for digital cleaning validation, and iOps™ for digital operations and electronic logbooks) and the Process Lifecycle Suite (iCMC™ for Quality by Design process development and iCPV™ for continued process verification), all unified under the Smart GxP™ AI-enabled backbone. The VAL™ AI Validation Assistant adds generative-AI document generation, gap assessment, automated execution, and anomaly detection on top of the workflow platform, with claimed outcomes of up to 80% reduction in validation cycle time, 90% reduction in validation observations, and 30% cost reduction.
The company operates an enterprise field-sales GTM motion targeting large regulated life sciences buyers, supplemented by channel partnerships (notably Validator K.K. in Japan) and supported by an annual user conference (ValConnect), industry events (ISPE), webinars, and a content marketing program. Pricing is quote-based, sold as annual subscription licensing with implementation and support services, and revenue is not publicly disclosed. ValGenesis holds the first patent for paperless validation and aligns its platform with FDA, EMA, ICH Q9/Q12, GAMP 5, 21 CFR Part 11, and EU Annex 11; named customers include Roche, Bayer, GSK, Corden Pharma, Alexion, Strides, Philips, Stryker, Biocon, MilliporeSigma, Catalent, Dr. Reddy's, Illumina, Alkermes, Noven, Transcat, Theragent, and LOTTE Biologics. The company has raised approximately $40.4M in cumulative disclosed funding (including a $16M strategic financing in July 2025 from Bridge Bank and Morgan Stanley Expansion Capital), acquired Portugal-based 4Tune Engineering in June 2022, and recently appointed a new Chief Revenue Officer (Wayne Baker) to accelerate global sales execution.
ValGenesis firmographics
Firmographics- Name
- ValGenesis
- Legal name
- ValGenesis, Inc.
- Website
- https://valgenesis.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 501–1,000 employees
- Ownership category
- akta.pro rank
ValGenesis industry classification
Industry- Product category
- Life Sciences Validation Software
- NAICS
- Software Publishers (51321)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI)
- akta.pro secondary industry
- AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO)
Keywords
Where ValGenesis is headquartered
LocationHeadquarters
- HQ city
- Fremont
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
ValGenesis business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure, Others
Revenue model
- Software Platform Licensing and Subscription: AI-enabled digital validation platform delivered as SaaS/subscription model. ValGenesis Smart GxP platform provides validation lifecycle management across Validation Lifecycle Suite and Process Lifecycle Suite products. Revenue derived from software licensing, implementation services, and ongoing support.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Enterprise subscription model - quote-based pricing |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels7 records
ValGenesis product offering
Product offeringCore offering
ValGenesis develops and sells the Smart GxP AI-enabled digital validation platform, unifying development, commissioning, qualification, validation, and continued process verification for the life sciences industry. The platform comprises the Validation Lifecycle Suite (iVal, iClean, iOps) and the Process Lifecycle Suite (iCMC, iCPV), sold as enterprise SaaS subscriptions to pharmaceutical, biotechnology, and medical device manufacturers.
Product overview
ValGenesis is an AI-powered digital validation and process lifecycle management company serving the life sciences industry. The company offers two main platform suites: the Validation Lifecycle Suite (comprising iVal, iClean, and iOps) and the Process Lifecycle Suite (comprising iCMC and iCPV), unified under the ValGenesis Smart GxP™ AI-enabled platform. The portfolio covers the full product lifecycle from drug process design through commercial performance, with products addressing commissioning, qualification, validation (CQV), computer software validation (CSV), cleaning validation, electronic logbooks, quality by design (QbD), and continued process verification (CPV). The company acquired Portugal-based 4Tune Engineering in 2022 to expand its manufacturing sciences capabilities.
Differentiator
Problem solved
Functional benefit
Brands
- Smart GxP™: AI-enabled digital validation platform that seamlessly unifies development, commissioning, qualification, validation, and continued process verification.
- Validation Lifecycle Suite (VLS)
- Process Lifecycle Suite (PLS)
- iVal™
- iClean™
- iOps™
- iCMC™
- iCPV™
- VAL™
Products and services
- ValGenesis Smart GxP™ Platform
Quantifiable outcome
- Validation cycle time reduced by up to 80%
- +7 more outcomes
Companies that use ValGenesis
Customer profileNamed customers19 records
Segments4 records
Ideal customer profiles4 records
ValGenesis technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration15 records
AI capability9 records
Feature8 records
ValGenesis partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and strategic.
- Validator K.K.coreValidator K.K. designated as Excellence Partner in Japan, responsible for implementing ValGenesis digital validation solutions across Japan's life sciences sector. The partnership extends digital validation capabilities to pharmaceutical and biotechnology companies, addressing regulatory compliance, labor shortages, and digitalization challenges in Japan. Validator K.K. resells Validation Lifecycle Suite and serves as referral partner for Process Lifecycle Suite.
- LOTTE BiologicscoreSouth Korea-headquartered CDMO successfully implemented ValGenesis e-Logbook solution at satellite QC lab in Songdo. Implementation replaces paper-based logbooks with real-time digital forms featuring QR/barcode-based selection, offline data capture, and automated review workflows. Plans to extend platform across main laboratory and production facilities at Songdo Bio Campus and Syracuse, New York facility.
- 4Tune EngineeringstrategicPortugal-based company specializing in manufacturing sciences and technologies. Acquisition completed June 6, 2022, aimed to expand ValGenesis' product portfolio, enhance validation lifecycle management systems, accelerate Pharma 4.0 strategy, and strengthen presence in European and LATAM markets.
Scale indicators11 records
Recent moves6 records
Expansion highlights7 records
ValGenesis competitors and assessment
Company assessmentDirect peers
- Veeva Systems: Veeva's Vault QualityDocs and Vault Validation products provide cloud-based quality and validation document management for life sciences. Overlaps directly with ValGenesis's validation lifecycle and document-centric offerings, both targeting pharma/biotech GxP buyers.
- MasterControl: MasterControl offers a unified quality and validation platform (Validation, QMS, EQMS) used by pharmaceutical and medical device manufacturers. Direct competitor in digital validation, especially for CSV and equipment qualification use cases.
- Kneat (now part of Stibo Systems): Kneat's e-Validation platform digitizes commissioning, qualification, and validation lifecycles in life sciences. Closely comparable as a paperless validation SaaS targeting the same regulated pharma/biotech/medtech buyers.
Broad incumbents
- Sparta Systems (a Honeywell company): TrackWise QMS and quality solutions from Sparta (Honeywell) serve pharma/life sciences including validation-related workflows. Competes broadly with ValGenesis on regulated quality and validation capabilities backed by a much larger parent.
- ArisGlobal: LifeSphere platform (QMS, regulatory, safety) serving large pharma/biotech including validation-adjacent workflows. A broader regulated quality suite that overlaps with ValGenesis's GxP compliance buyers.
- IQVIA (Quality Compliance): IQVIA's technology and services portfolio includes quality/compliance and lab digital solutions for life sciences. A broad incumbent with overlap to ValGenesis's pharma/medtech GxP buyers.
Emerging players
- Qualio: Qualio provides cloud-native eQMS and validation tools for life sciences startups and mid-market pharma/medtech. Smaller-scale overlap with ValGenesis, particularly in CSV and document management for regulated quality systems.
- Dot Compliance: Provides AI-enabled quality and compliance management (eQMS) for pharma and medical device manufacturers. Emerging competitor in AI-augmented QMS with partial overlap to ValGenesis's VAL AI approach.
- Greenlight Guru: Quality management software purpose-built for medical device companies under ISO 13485 and FDA requirements. Adjacent overlap with ValGenesis's medical-device validation segment.
- ComplianceQuest: Next-gen QMS, EQMS, and quality management solution built on Salesforce targeting life sciences manufacturers. Competes with ValGenesis in regulated quality and validation documentation.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat6 records
Key risks5 records
Key highlights6 records
Customer concentration
ValGenesis social profiles
Digital presenceValGenesis compliance and trust
Trust signalCompliance2 records
ValGenesis financial estimates
Financial estimateRevenue estimate
Valuation estimate
ValGenesis leadership team
Management profileNumber of profiles
Profiles9 records
ValGenesis subsidiaries and ownership
Company hierarchySubsidiaries1 record
ValGenesis funding detail
Funding detailFunding overview
Funding rounds3 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ValGenesis M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ValGenesis
What does ValGenesis do?
ValGenesis develops and sells the Smart GxP AI-enabled digital validation platform, unifying development, commissioning, qualification, validation, and continued process verification for the life sciences industry. The platform comprises the Validation Lifecycle Suite (iVal, iClean, iOps) and the Process Lifecycle Suite (iCMC, iCPV), sold as enterprise SaaS subscriptions to pharmaceutical, biotechnology, and medical device manufacturers.
Is ValGenesis a public or private company?
ValGenesis is a private company. It is classified as venture growth investor backed and is currently operating.
When was ValGenesis founded?
ValGenesis was founded in 2005. It employs 501 to 1,000 people.
Where is ValGenesis based?
ValGenesis is headquartered in Fremont, United States, in the North America region.
How does ValGenesis make money?
One revenue line is on record: software Platform Licensing and Subscription.
Who are ValGenesis's main competitors?
Direct peers on record are Veeva Systems, MasterControl and Kneat (now part of Stibo Systems). Broad incumbents are Sparta Systems (a Honeywell company), ArisGlobal and IQVIA (Quality Compliance). Emerging players are Qualio, Dot Compliance, Greenlight Guru and ComplianceQuest.
Does ValGenesis have an API?
No public API is recorded for ValGenesis.
What industry is ValGenesis in?
ValGenesis's product category is Life Sciences Validation Software. Its primary akta.pro industry code is HLAGAJAI, Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs), with a secondary code of HLAGAJAO, AI/ML Platforms for Drug Discovery & Experiment Optimization. Its NAICS code is 51321 and its SIC code is 7372.