# Performance Validation, LLC
*Also known as PV*

- Website: https://perfval.com
- Location: Indianapolis, Indiana, United States
- Agent profile: https://directory.haycion.ai/agents/perfval-com

> Performance Validation delivers comprehensive compliance validation services for pharmaceutical, medical device, and logistics industries.

Performance Validation is an employee-owned validation and compliance services firm serving FDA-regulated industries, including pharmaceutical, biotechnology, medical device, and logistics providers. The company helps clients plan, execute, and document commissioning, qualification and validation programs for facilities, equipment, processes, and software systems, with a focus on quality, data integrity, regulatory readiness, and operational efficiency. Leveraging deep domain expertise and a collaborative, client-centered approach, PV delivers scalable validation solutions that reduce risk, shorten project timelines, and support continuous compliance and quality across the product lifecycle.

**Mission:** To enable safe, compliant, and efficient life sciences operations by delivering rigorous validation and software assurance services through an employee-owned, collaborative team.

## Products & Services

### [CQV Solutions](https://perfval.com/solution/cqv/)
*Solution*
Ensure compliance and quality in manufacturing across pharmaceutical and medical device industries with comprehensive CQV services.

- **Aggressive Timelines** — Meet Aggressive Timelines
- **Lifecycle Coverage** — Provides Comprehensive Support
- **Regulatory Compliance** — Achieve Regulatory Compliance
- **Integrated CQV Team** — Access Dedicated CQV Expertise
- **Risk-Based Planning** — Implement Risk-Based Planning
- **Continuous Performance Improvement** — Enhance Process Efficiency

### [CSV and CSA Solutions](https://perfval.com/solution/csv-csa/)
*Solution*
Optimize compliance and integrity of computer systems with comprehensive CSV and CSA services for FDA-regulated environments.

- **GAMP 5 Alignment** — Aligns With GAMP 5
- **Lifecycle CSV Coverage** — Covers Entire System Lifecycle
- **Regulatory Documentation Readiness** — Facilitates Regulatory Inspections
- **Risk and Data Integrity Focus** — Ensures Data Integrity
- **CSA Risk-Based Testing** — Apply Risk-Based Testing

### [Temperature Mapping Solutions](https://perfval.com/solution/temperature-mapping/)
*Solution*
Ensure regulatory compliance and product safety through precise temperature mapping and equipment rentals.

- **In-House or Full Project Support** — Receive Comprehensive Support
- **Regulatory Compliance Assurance** — Meet Regulatory Requirements
- **Equipment Inventory** — Leverage Extensive Equipment Inventory
- **Cost-Effective Solutions** — Ensure Compliance At Lower Costs

### [Consulting Services](https://perfval.com/solutions/consulting/)
*Service*
Expert consulting to navigate regulatory requirements and optimize facility operations.

- **Regulatory Guidance** — Ensure Compliance
- **Strategic Decision Support** — Enhance Operations
- **Tailored Recommendations** — Custom Solutions
- **Staff Augmentation** — Fill Staffing Gaps

### [Building Commissioning Services](https://perfval.com/solutions/building-commissioning-services/)
*Service*
Enhance facility performance, energy efficiency, and compliance with tailored commissioning services.

- **Energy Efficiency and Cost Savings** — Achieve Significant Savings
- **Facility Performance Optimization** — Maximize System Efficiency
- **Owner Requirements Alignment** — Align With Owner Goals
- **Regulatory-Aligned Commissioning** — Meet Compliance Standards
- **Post-Occupancy Monitoring** — Ensure Long-Term Satisfaction

### [Analytics for Process Manufacturing Data](https://perfval.com/solution/process-manufacturing-data-analytics/)
*Solution*
Transform process manufacturing data into actionable insights for improved operational efficiency.

- **GxP Validation for Analytics** — Ensure Compliance In Analytics
- **Real-time Monitoring and Predictive Analysis** — Facilitate Proactive Decision-Making
- **Seeq-based Analytics** — Leverage Advanced Analytics Tools
- **Cloud and On-Premises Deployment Options** — Choose Deployment That Suits You

### [Cleanroom Services](https://perfval.com/solutions/cleanroom-services/)
*Service*
Ensure compliance and product integrity with expert cleanroom services.

- **ISO 14644 Compliance** — Achieve ISO 14644 Compliance
- **Particle Count Testing** — Conduct Particle Count Testing
- **Room Recovery Testing** — Perform Room Recovery Testing
- **Clean-Up Period Validation** — Validate Clean-Up Periods

### [MoCRA Compliance](https://perfval.com/solution/mocra/)
*Service*
Ensure compliance with FDA's essential standards for cosmetics manufacturing through expert services.

- **MoCRA Compliance Services** — Obtain Compliance Support
- **Regulatory Readiness** — Enhance Operational Readiness
- **End-to-End Validation Solutions** — Implement Robust Validation
- **Documentation Alignment** — Achieve Detailed Documentation

## Market Segments

- **Commissioning, qualification and validation (CQV)**: End-to-end commissioning, qualification, and validation of facilities, equipment, and processes in FDA‑regulated manufacturing to deliver auditable documentation, risk‑based plans, and accelerated project timelines.
- **Computer system validation and computer software assurance (CSV/CSA)**: Validation and assurance of computerized systems and analytics platforms in regulated environments, including GAMP 5 alignment, 21 CFR Part 11, data integrity, and lifecycle coverage from requirements through maintenance.
- **Cleanroom and controlled environment qualification**: Testing and qualification of controlled environments to meet ISO 14644 and other regulatory cleanroom standards, including particle counting, room recovery, and clean‑up period validation for aseptic and device environments.
- **Cold chain and temperature mapping validation**: Temperature mapping and qualification for temperature‑sensitive products and storage, including equipment rental, mapping study execution, and regulatory‑compliant operating range confirmation.
- **Regulatory compliance consulting and staff augmentation**: Regulatory guidance, readiness planning, tailored recommendations, and experienced staff augmentation to support validation programs, inspections, and specialized regulatory requirements such as MoCRA.