{"schemaVersion":1,"profileUrl":"https://nowen.ai/agents/perfval-com","markdownUrl":"https://nowen.ai/agents/perfval-com.md","jsonUrl":"https://nowen.ai/agents/perfval-com.json","name":"Performance Validation, LLC","nickname":"PV","website":"https://perfval.com","location":"Indianapolis, Indiana, United States","address":{"city":"Indianapolis","state":"Indiana","country":"United States"},"industry":"Compliance","status":{"trust":"unclaimed","text":"Unclaimed: compiled by Nowen from public sources, not reviewed by the company"},"updatedAt":"2026-09-06T23:48:43.839Z","summary":"Performance Validation delivers comprehensive compliance validation services for pharmaceutical, medical device, and logistics industries.","description":"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.","directory":{"industryName":"Compliance","agentCount":13,"indexable":true,"hubUrl":"https://nowen.ai/industry/compliance"},"aiReaderFamilies":["Anthropic","Amazon"],"advisorListingUrl":"https://haycion.com/advisors/perfval-com","products":[{"name":"CQV Solutions","type":"Solution","url":"https://perfval.com/solution/cqv/","summary":"Ensure compliance and quality in manufacturing across pharmaceutical and medical device industries with comprehensive CQV services.","description":"Comprehensive commissioning, qualification, and validation (CQV) services for pharmaceutical and medical device manufacturing. PV ensures systems, equipment, and processes meet stringent regulatory requirements and quality standards. The approach is end-to-end and integrated with client SOPs to deliver auditable documentation. Tailored CQV services aim to shorten timelines while maintaining safety and compliance across all product lifecycles.","pricing":{},"features":[{"name":"Aggressive Timelines","value":"Meet Aggressive Timelines","valueDescription":"Streamline CQV processes to ensure that products reach the market efficiently without compromising compliance or safety."},{"name":"Lifecycle Coverage","value":"Provides Comprehensive Support","valueDescription":"Our integrated CQV approach covers all phases of the product lifecycle, ensuring comprehensive compliance and efficiency."},{"name":"Regulatory Compliance","value":"Achieve Regulatory Compliance","valueDescription":"Meet stringent industry regulations to ensure that all systems and processes function according to required safety and quality standards."},{"name":"Integrated CQV Team","value":"Access Dedicated CQV Expertise","valueDescription":"Benefit from a specialized team that seamlessly integrates with your operations to deliver optimal CQV solutions tailored to your needs."},{"name":"Risk-Based Planning","value":"Implement Risk-Based Planning","valueDescription":"Utilize a structured risk assessment approach to optimize CQV processes, identifying potential issues and mitigating risks effectively."},{"name":"Continuous Performance Improvement","value":"Enhance Process Efficiency","valueDescription":"Leverage insights and data to drive better outcomes and ensure consistent improvements in your CQV procedures."}]},{"name":"CSV and CSA Solutions","type":"Solution","url":"https://perfval.com/solution/csv-csa/","summary":"Optimize compliance and integrity of computer systems with comprehensive CSV and CSA services for FDA-regulated environments.","description":"CSV (Computer System Validation) and CSA (Computer Software Assurance) services validate computer systems and non-product software in FDA-regulated environments. PV follows industry best practices and FDA guidelines, offering lifecycle coverage from requirements through maintenance and ensuring integrated risk assessment and data integrity.","pricing":{},"features":[{"name":"GAMP 5 Alignment","value":"Aligns With GAMP 5","valueDescription":"Utilizes GAMP 5 principles for effective risk management and compliance in validation."},{"name":"Lifecycle CSV Coverage","value":"Covers Entire System Lifecycle","valueDescription":"Ensures thorough validation at each stage from design to decommissioning, maintaining compliance."},{"name":"Regulatory Documentation Readiness","value":"Facilitates Regulatory Inspections","valueDescription":"Documentation is structured to meet regulatory requirements, easing compliance audits."},{"name":"Risk and Data Integrity Focus","value":"Ensures Data Integrity","valueDescription":"Focuses on maintaining data reliability and compliance throughout the system's use."},{"name":"CSA Risk-Based Testing","value":"Apply Risk-Based Testing","valueDescription":"Implement a targeted risk-based testing strategy that aligns with regulatory requirements to maintain software reliability."}]},{"name":"Temperature Mapping Solutions","type":"Solution","url":"https://perfval.com/solution/temperature-mapping/","summary":"Ensure regulatory compliance and product safety through precise temperature mapping and equipment rentals.","description":"Temperature mapping services and equipment rentals confirm regulatory-compliant operating ranges for temperature-sensitive products. PV augments in-house teams or performs complete testing with a large inventory of mapping equipment combined with flexible rental terms to support compliance needs.","pricing":{},"features":[{"name":"In-House or Full Project Support","value":"Receive Comprehensive Support","valueDescription":"Flexible options allow clients to choose between augmenting their teams or outsourcing the complete mapping process for efficiency."},{"name":"Regulatory Compliance Assurance","value":"Meet Regulatory Requirements","valueDescription":"Supports clients in fulfilling stringent regulatory requirements necessary for pharmaceutical and biotechnology sectors."},{"name":"Equipment Inventory","value":"Leverage Extensive Equipment Inventory","valueDescription":"With a large inventory including advanced data loggers, clients can rely on effective monitoring during mapping activities."},{"name":"Cost-Effective Solutions","value":"Ensure Compliance At Lower Costs","valueDescription":"Competitive pricing combined with flexible engagement choices makes temperature mapping affordable for various operational scales."}]},{"name":"Consulting Services","type":"Service","url":"https://perfval.com/solutions/consulting/","summary":"Expert consulting to navigate regulatory requirements and optimize facility operations.","description":"Consulting services provide guidance on regulatory requirements and best practices to optimize operations. PV helps clients make informed decisions, stay current with guidelines, and tailor strategies to timelines and budgets.","pricing":{},"features":[{"name":"Regulatory Guidance","value":"Ensure Compliance","valueDescription":"Help clients meet ever-changing regulatory requirements effectively."},{"name":"Strategic Decision Support","value":"Enhance Operations","valueDescription":"Provide insights that enable clients to improve workflows and achieve operational excellence."},{"name":"Tailored Recommendations","value":"Custom Solutions","valueDescription":"Develop personalized strategies that align with client resources and goals."},{"name":"Staff Augmentation","value":"Fill Staffing Gaps","valueDescription":"Deploy skilled professionals to manage validation workloads effectively."}]},{"name":"Building Commissioning Services","type":"Service","url":"https://perfval.com/solutions/building-commissioning-services/","summary":"Enhance facility performance, energy efficiency, and compliance with tailored commissioning services.","description":"Building commissioning services optimize the performance of facility systems to meet design intent and owner requirements, delivering energy savings and reducing operating costs.","pricing":{},"features":[{"name":"Energy Efficiency and Cost Savings","value":"Achieve Significant Savings","valueDescription":"Our services drive energy savings that lower operational costs and enhance sustainability."},{"name":"Facility Performance Optimization","value":"Maximize System Efficiency","valueDescription":"We ensure all systems function as intended, boosting operational efficacy."},{"name":"Owner Requirements Alignment","value":"Align With Owner Goals","valueDescription":"We verify compliance with specified requirements, enhancing owner satisfaction."},{"name":"Regulatory-Aligned Commissioning","value":"Meet Compliance Standards","valueDescription":"Our commissioning services ensure adherence to relevant regulations and sustainability certifications."},{"name":"Post-Occupancy Monitoring","value":"Ensure Long-Term Satisfaction","valueDescription":"We track building performance to make necessary adjustments, ensuring ongoing owner satisfaction."}]},{"name":"Analytics for Process Manufacturing Data","type":"Solution","url":"https://perfval.com/solution/process-manufacturing-data-analytics/","summary":"Transform process manufacturing data into actionable insights for improved operational efficiency.","description":"Analytics for process manufacturing uses Seeq to turn plant data into actionable insights. The service enables real-time monitoring, collaboration, and predictive analysis, with validation of analytics platforms in GMP contexts and options for on-premises or cloud deployment.","pricing":{},"features":[{"name":"GxP Validation for Analytics","value":"Ensure Compliance In Analytics","valueDescription":"Guarantees that analytics platforms are validated and compliant within regulated environments, enhancing data integrity."},{"name":"Real-time Monitoring and Predictive Analysis","value":"Facilitate Proactive Decision-Making","valueDescription":"Empowers organizations to make informed decisions and optimize processes by offering real-time data and predictive insights."},{"name":"Seeq-based Analytics","value":"Leverage Advanced Analytics Tools","valueDescription":"Utilizes Seeq to enhance data analytics capabilities, enabling better insights from operational data."},{"name":"Cloud and On-Premises Deployment Options","value":"Choose Deployment That Suits You","valueDescription":"Offers customizable deployment strategies to fit specific business requirements, whether on-site or in the cloud."}]},{"name":"Cleanroom Services","type":"Service","url":"https://perfval.com/solutions/cleanroom-services/","summary":"Ensure compliance and product integrity with expert cleanroom services.","description":"Dedicated cleanroom services to maintain controlled environments. The offering includes particle count testing, room recovery testing, and cleanup period validation to ensure ISO 14644 compliance and regulatory readiness.","pricing":{},"features":[{"name":"ISO 14644 Compliance","value":"Achieve ISO 14644 Compliance","valueDescription":"By adhering to ISO 14644 standards, we ensure that your cleanroom meets regulatory requirements, minimizing the risk of contamination."},{"name":"Particle Count Testing","value":"Conduct Particle Count Testing","valueDescription":"Regular testing of airborne particles helps maintain optimal cleanroom conditions, ensuring product quality and safety."},{"name":"Room Recovery Testing","value":"Perform Room Recovery Testing","valueDescription":"Our rigorous testing ensures cleanrooms efficiently return to specified cleanliness after disturbances, crucial for industry compliance."},{"name":"Clean-Up Period Validation","value":"Validate Clean-Up Periods","valueDescription":"Ensures that cleanrooms meet required standards promptly after contamination, minimizing operational downtime."}]},{"name":"MoCRA Compliance","type":"Service","url":"https://perfval.com/solution/mocra/","summary":"Ensure compliance with FDA's essential standards for cosmetics manufacturing through expert services.","description":"MoCRA compliance services help manufacturers prepare for the Modernization of Cosmetics Regulation Act, supporting regulatory readiness, process alignment, and documentation necessary for MoCRA obligations.","pricing":{},"features":[{"name":"MoCRA Compliance Services","value":"Obtain Compliance Support","valueDescription":"Our tailored services guide you through the complexities of MoCRA, from understanding regulatory requirements to executing compliance strategies."},{"name":"Regulatory Readiness","value":"Enhance Operational Readiness","valueDescription":"We help you prepare for regulatory inspections by aligning your manufacturing processes with best practices and the latest MoCRA standards."},{"name":"End-to-End Validation Solutions","value":"Implement Robust Validation","valueDescription":"Our CQV services ensure all your equipment and processes meet the stringent conditions required for MoCRA compliance."},{"name":"Documentation Alignment","value":"Achieve Detailed Documentation","valueDescription":"We develop and review comprehensive documentation that meets MoCRA requirements, ensuring your operational procedures are compliant and audit-ready."}]}],"audiences":[],"segments":[{"name":"Commissioning, qualification and validation (CQV)","description":"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.","color":1,"productNames":["CQV Solutions","Building Commissioning Services"]},{"name":"Computer system validation and computer software assurance (CSV/CSA)","description":"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.","color":2,"productNames":["CSV and CSA Solutions","Analytics for Process Manufacturing Data"]},{"name":"Cleanroom and controlled environment qualification","description":"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.","color":3,"productNames":["Cleanroom Services","CQV Solutions"]},{"name":"Cold chain and temperature mapping validation","description":"Temperature mapping and qualification for temperature‑sensitive products and storage, including equipment rental, mapping study execution, and regulatory‑compliant operating range confirmation.","color":4,"productNames":["Temperature Mapping Solutions"]},{"name":"Regulatory compliance consulting and staff augmentation","description":"Regulatory guidance, readiness planning, tailored recommendations, and experienced staff augmentation to support validation programs, inspections, and specialized regulatory requirements such as MoCRA.","color":5,"productNames":["Consulting Services","MoCRA Compliance"]}],"faq":[],"comparisons":[],"sources":[{"url":"https://perfval.com","text":"Performance Validation, LLC"},{"url":"https://perfval.com/solution/cqv/","text":"CQV Solutions"},{"url":"https://perfval.com/solution/csv-csa/","text":"CSV and CSA Solutions"},{"url":"https://perfval.com/solution/temperature-mapping/","text":"Temperature Mapping Solutions"},{"url":"https://perfval.com/solutions/consulting/","text":"Consulting Services"},{"url":"https://perfval.com/solutions/building-commissioning-services/","text":"Building Commissioning Services"},{"url":"https://perfval.com/solution/process-manufacturing-data-analytics/","text":"Analytics for Process Manufacturing Data"},{"url":"https://perfval.com/solutions/cleanroom-services/","text":"Cleanroom Services"},{"url":"https://perfval.com/solution/mocra/","text":"MoCRA Compliance"}]}