Performance Validation, LLC Unclaimed

Ensure compliance and quality in manufacturing across pharmaceutical and medical device industries with comprehensive CQV services.

Optimize compliance and integrity of computer systems with comprehensive CSV and CSA services for FDA-regulated environments.

Ensure regulatory compliance and product safety through precise temperature mapping and equipment rentals.

Expert consulting to navigate regulatory requirements and optimize facility operations.

Enhance facility performance, energy efficiency, and compliance with tailored commissioning services.

Transform process manufacturing data into actionable insights for improved operational efficiency.

Ensure compliance and product integrity with expert cleanroom services.

Ensure compliance with FDA's essential standards for cosmetics manufacturing through expert services.

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.

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.

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.

Temperature mapping and qualification for temperature‑sensitive products and storage, including equipment rental, mapping study execution, and regulatory‑compliant operating range confirmation.

Regulatory guidance, readiness planning, tailored recommendations, and experienced staff augmentation to support validation programs, inspections, and specialized regulatory requirements such as MoCRA.

CQV Solutions

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.

• Meet Aggressive Timelines
  Streamline CQV processes to ensure that products reach the market efficiently without compromising compliance or safety.
• Provides Comprehensive Support
  Our integrated CQV approach covers all phases of the product lifecycle, ensuring comprehensive compliance and efficiency.
• Achieve Regulatory Compliance
  Meet stringent industry regulations to ensure that all systems and processes function according to required safety and quality standards.
• Access Dedicated CQV Expertise
  Benefit from a specialized team that seamlessly integrates with your operations to deliver optimal CQV solutions tailored to your needs.
• Implement Risk-Based Planning
  Utilize a structured risk assessment approach to optimize CQV processes, identifying potential issues and mitigating risks effectively.
• Enhance Process Efficiency
  Leverage insights and data to drive better outcomes and ensure consistent improvements in your CQV procedures.

CSV and CSA Solutions

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.

• Aligns With GAMP 5
  Utilizes GAMP 5 principles for effective risk management and compliance in validation.
• Covers Entire System Lifecycle
  Ensures thorough validation at each stage from design to decommissioning, maintaining compliance.
• Facilitates Regulatory Inspections
  Documentation is structured to meet regulatory requirements, easing compliance audits.
• Ensures Data Integrity
  Focuses on maintaining data reliability and compliance throughout the system's use.
• Apply Risk-Based Testing
  Implement a targeted risk-based testing strategy that aligns with regulatory requirements to maintain software reliability.

Temperature Mapping Solutions

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.

• Receive Comprehensive Support
  Flexible options allow clients to choose between augmenting their teams or outsourcing the complete mapping process for efficiency.
• Meet Regulatory Requirements
  Supports clients in fulfilling stringent regulatory requirements necessary for pharmaceutical and biotechnology sectors.
• Leverage Extensive Equipment Inventory
  With a large inventory including advanced data loggers, clients can rely on effective monitoring during mapping activities.
• Ensure Compliance At Lower Costs
  Competitive pricing combined with flexible engagement choices makes temperature mapping affordable for various operational scales.

Consulting Services

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.

• Ensure Compliance
  Help clients meet ever-changing regulatory requirements effectively.
• Enhance Operations
  Provide insights that enable clients to improve workflows and achieve operational excellence.
• Custom Solutions
  Develop personalized strategies that align with client resources and goals.
• Fill Staffing Gaps
  Deploy skilled professionals to manage validation workloads effectively.

Building Commissioning Services

Building commissioning services optimize the performance of facility systems to meet design intent and owner requirements, delivering energy savings and reducing operating costs.

• Achieve Significant Savings
  Our services drive energy savings that lower operational costs and enhance sustainability.
• Maximize System Efficiency
  We ensure all systems function as intended, boosting operational efficacy.
• Align With Owner Goals
  We verify compliance with specified requirements, enhancing owner satisfaction.
• Meet Compliance Standards
  Our commissioning services ensure adherence to relevant regulations and sustainability certifications.
• Ensure Long-Term Satisfaction
  We track building performance to make necessary adjustments, ensuring ongoing owner satisfaction.

Analytics for Process Manufacturing Data

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.

• Ensure Compliance In Analytics
  Guarantees that analytics platforms are validated and compliant within regulated environments, enhancing data integrity.
• Facilitate Proactive Decision-Making
  Empowers organizations to make informed decisions and optimize processes by offering real-time data and predictive insights.
• Leverage Advanced Analytics Tools
  Utilizes Seeq to enhance data analytics capabilities, enabling better insights from operational data.
• Choose Deployment That Suits You
  Offers customizable deployment strategies to fit specific business requirements, whether on-site or in the cloud.

Cleanroom Services

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.

• Achieve ISO 14644 Compliance
  By adhering to ISO 14644 standards, we ensure that your cleanroom meets regulatory requirements, minimizing the risk of contamination.
• Conduct Particle Count Testing
  Regular testing of airborne particles helps maintain optimal cleanroom conditions, ensuring product quality and safety.
• Perform Room Recovery Testing
  Our rigorous testing ensures cleanrooms efficiently return to specified cleanliness after disturbances, crucial for industry compliance.
• Validate Clean-Up Periods
  Ensures that cleanrooms meet required standards promptly after contamination, minimizing operational downtime.

MoCRA Compliance

MoCRA compliance services help manufacturers prepare for the Modernization of Cosmetics Regulation Act, supporting regulatory readiness, process alignment, and documentation necessary for MoCRA obligations.

• Obtain Compliance Support
  Our tailored services guide you through the complexities of MoCRA, from understanding regulatory requirements to executing compliance strategies.
• Enhance Operational Readiness
  We help you prepare for regulatory inspections by aligning your manufacturing processes with best practices and the latest MoCRA standards.
• Implement Robust Validation
  Our CQV services ensure all your equipment and processes meet the stringent conditions required for MoCRA compliance.
• Achieve Detailed Documentation
  We develop and review comprehensive documentation that meets MoCRA requirements, ensuring your operational procedures are compliant and audit-ready.