What Performance Validation does

Performance Validation, Inc. is a U.S.-based professional services firm founded in 1988 and headquartered in Indianapolis, Indiana, specializing in commissioning, qualification, and validation (CQV) services for FDA-regulated industries. The company serves pharmaceutical manufacturers, medical device companies, biotechnology firms, CDMOs/CMOs, and adjacent regulated verticals (3PLs, healthcare facilities, cosmetics under MoCRA), delivering a portfolio of services that includes CQV, Computer System Validation (CSV), Computer Software Assurance (CSA), temperature mapping, critical airflow visualization, AS/RS qualification, cleanroom services, digital validation, building commissioning, and consulting.

The firm's underlying technology is built on risk-based validation methodologies aligned with GAMP 5, ICH Q9, ASTM E2500, FDA CSA guidelines, and 21 CFR Part 11. It maintains one of the largest temperature mapping equipment inventories in the country and integrates third-party platforms such as Seeq (process analytics, anomaly detection, predictive analytics) and ValGenesis (enterprise validation lifecycle management) to deliver digital and paperless validation engagements. All services are delivered by in-house subject matter experts rather than through a software product.

Performance Validation operates as a 100% employee-owned ESOP with no external investors or parent company. Revenue is generated through project-based professional services engagements and staff augmentation, with pricing that is quote-based and project-specific, plus ancillary revenue from temperature mapping equipment rentals. The go-to-market motion is enterprise field sales, supported by content-driven marketing (white papers, webinars, case studies, podcast), with seven regional hubs across Indiana, Michigan, Washington, Illinois, Kansas, North Carolina, and Wisconsin enabling nationwide service delivery.

Name

Performance Validation

Legal name

Performance Validation, Inc.

Website

https://perfval.com

Company type

Private

Founded year

1988

Operating status

Operating

Headcount range

101–250 employees

Short description

Performance Validation is a 100% employee-owned U.S. professional services firm founded in 1988, providing commissioning, qualification, and validation (CQV) services to pharmaceutical, biotech, medical device, and CDMO manufacturers. It delivers risk-based validation, digital validation, and process analytics across seven regional hubs nationwide.

Ownership category

akta.pro rank

Headquarters

HQ city

Indianapolis

HQ country

United States

HQ region

North America

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CQV (Commissioning, Qualification and Validation) Services: Project-based professional services for commissioning, qualification, and validation of facilities, equipment, utilities, and systems for life sciences organizations. Services range from small system qualifications to multi-million-dollar greenfield manufacturing facilities projects.
2. Staff Augmentation: Deploying experienced validation professionals to clients to fill staffing gaps and complete critical validation projects on demand.
3. Temperature Mapping Equipment Rentals: Rental of temperature mapping equipment for clients needing to conduct temperature mapping studies for regulatory compliance.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels8 records

Core offering

Performance Validation is a professional services firm that delivers commissioning, qualification, and validation (CQV) and related compliance services for FDA-regulated life sciences manufacturers, including pharmaceutical, biotech, medical device, CDMO/CMO, 3PL, healthcare, and government facility clients. Its offerings span full CQV project execution, Computer System Validation (CSV), Computer Software Assurance (CSA), temperature mapping and equipment rentals, critical airflow visualization, cleanroom services, building commissioning, PPAP, MoCRA compliance, AS/RS qualification, and digital validation services supported by Seeq analytics and ValGenesis tooling.

Product overview

Performance Validation is a validation services company (not a software product company) offering a comprehensive portfolio of expert services for FDA-regulated industries. The core offerings include CQV Pharma Services, CQV Medical Devices, Computer System Validation (CSV), Computer Software Assurance (CSA), Temperature Mapping, Critical Airflow Visualization (CAV), Building Commissioning, PPAP, and MoCRA Compliance services. Supporting services include Digital Validation/Digital Validation Tools, Validation for 3PLs, Analytics for Process Manufacturing Data, Cleanroom Services, ASRS qualification, and Consulting. The company also offers Temperature Mapping Equipment Rentals as an add-on. All services are delivered by expert validation professionals who work within clients' standard operating procedures using risk-based approaches aligned with cGMP requirements.

Differentiator

Problem solved

Functional benefit

Products and services

• CQV Pharma Services Commissioning, Qualification, and Validation services for pharmaceutical manufacturing, covering facilities, equipment, utilities, and systems to ensure cGMP compliance for FDA-regulated manufacturers.
• CQV Medical Devices CQV services tailored to medical device manufacturers, supporting compliant facility, equipment, process, and system implementation in accordance with FDA QSR and ISO 13485.
• Computer System Validation (CSV) Validation services ensuring computerized systems are fit for intended use, maintain data integrity, and meet regulatory requirements for FDA-regulated industries.
• Temperature Mapping Temperature mapping services verifying environmental conditions, supporting regulatory compliance, and protecting product quality throughout storage and distribution for life sciences clients.
• Building Commissioning Building commissioning services optimizing performance, improving energy efficiency, and verifying systems operate as intended throughout the facility lifecycle for healthcare, education, and government clients.
• Critical Airflow Visualization (CAV) Airflow visualization services verifying airflow patterns, identifying contamination risks, and supporting compliance in critical manufacturing environments, including aseptic manipulations and equipment design.
• CSA (Computer Software Assurance) Risk-based assurance services helping organizations ensure software is fit for intended use while reducing validation effort and maintaining FDA compliance.
• PPAP (Production Part Approval Process) PPAP services helping manufacturers establish confidence in production processes, verify quality requirements, and support successful product launches.
• Digital Validation (as a Service) Digital validation solutions streamlining validation activities, improving collaboration, and reducing effort required to maintain compliance across the validation lifecycle.
• Validation for 3PLs Validation services tailored to third-party logistics providers, ensuring compliant storage, handling, and distribution of pharmaceutical products under GMP.
• Analytics for Process Manufacturing Data Advanced analytics solutions transforming manufacturing data into actionable insights, leveraging the Seeq platform for pattern recognition, real-time monitoring, anomaly detection, and predictive analytics.
• Cleanroom Services Comprehensive cleanroom services helping maintain contamination control, verify environmental performance, and support regulatory compliance in pharmaceutical and healthcare environments.
• MoCRA Compliance Compliance and validation support helping cosmetic manufacturers navigate MoCRA requirements and strengthen quality systems.
• ASRS (Automated Storage & Retrieval Systems) Qualification Qualification and validation services ensuring automated storage and retrieval systems perform reliably and remain compliant, delivered in partnership with Dematic for pharmaceutical clients.
• Consulting Technical consulting services helping organizations solve complex compliance, quality, validation, and operational challenges across life sciences manufacturing.
• Temperature Mapping Equipment Rentals Rental of temperature mapping equipment from one of the largest temperature mapping equipment inventories in the country, providing cost-effective hardware for temperature mapping studies.

Quantifiable outcome

• AS/RS downtime reduced to less than 2 hours per week on average vs. 20+ hours at similar sites using different systems
• +2 more outcomes

Named customers5 records

Segments8 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature3 records

Partnerships

Three partnerships are on record, tiered core and minor.

• ValGenesiscoreTechnology or Integration · 1 January 2025Performance Validation partnered with ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), to deliver unique compliance-focused digital validation solutions for life sciences companies in the US. This partnership combines PV's 30+ years of validation expertise with ValGenesis's VLMS technology platform.
• SeeqcoreTechnology or IntegrationPerformance Validation partnered with Seeq, a powerful data analytics platform purpose-built for process manufacturing. This partnership enables clients to automate analytical workflows including data cleansing, pattern recognition, customized dashboards, real-time monitoring and anomaly detection, and predictive analytics for process manufacturing data.
• DematicminorStrategic or Co-development PartnerDematic, a global supplier of automated warehouse solutions, partnered with Performance Validation for AS/RS validation projects. PV collaborated with Dematic's onsite team to validate automated storage and retrieval systems for pharmaceutical clients.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Others

• Seeq Corporation: Process-manufacturing analytics platform and PV's data analytics partner. Adjacent rather than directly competitive, enabling PV's AI-driven monitoring but not a CQV service provider.

Direct peers

• Integrated Project Services (IPS): Full-service engineering and validation firm focused on life sciences. Delivers CQV, CSV, and commissioning/qualification services that directly overlap with PV's core menu.
• Kymanox: US-based CQV/CSV and regulatory consulting firm focused on life sciences manufacturers. Operates in the same niche of pharma/biotech/medical device validation that PV targets.
• Commissioning Agents Inc (CAI): Engineering-led CQV, validation, and compliance services firm serving pharma and food/beverage manufacturers. Closely comparable service portfolio including CSV, CQV, and temperature mapping.
• PharmEng Technology: Pharmaceutical consulting and CQV firm offering validation, GMP, and engineering services to drug manufacturers; competes in the same life-sciences validation RFPs as PV.
• CRB Group: Engineering, architecture, and consulting firm with a substantial life-sciences CQV/validation practice. Competes for the same large greenfield pharma build-out projects PV cites.
• AVS Life Sciences: Specialty consulting firm dedicated to computer system validation and quality/compliance work for FDA-regulated life sciences — a tight functional overlap with PV's CSV practice.
• Atlantic Quality Consulting: CSV, CQV, and quality/compliance consultancy serving pharmaceutical and medical device manufacturers — closely comparable in customer base and scope.
• DPS Group: Global professional services and engineering firm providing CQV, validation, and process engineering to life-science clients. Overlaps with PV's facility/equipment qualification and CSV offerings.

Broad incumbents

• ValGenesis: Enterprise validation lifecycle management system (VLMS) software vendor and PV's stated digital-partner. Overlaps via digital validation tooling and adjacent implementation services, not core CQV fieldwork.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/perfval
• Facebookfacebook.com/profile.php?id=100081668888217
• LinkedInlinkedin.com/company/performance-validation
• Instagraminstagram.com/performance_validation

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments

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

Frequently asked questions about Performance Validation