White Papers

This white paper aims to clarify the changes in Annex 1, specifically focusing on airflow visualization and cleanroom testing, to help manufacturers understand the technical adjustments and the necessary steps to achieve compliance. By highlighting the differences between the 2008 and 2022 versions, this document will provide manufacturers with a practical guide to implementing the […]

This white paper provides a comprehensive analysis of the recent updates to the FDA’s 21 CFR 820 regulations for medical device manufacturing, aligning with ISO 13485. It covers the key differences between the regulatory frameworks, the implications for manufacturers, and how these changes impact compliance strategies. Readers will gain insight into implementation timelines, regulatory expectations, […]

The 21 CFR Part 11 regulation establishes guidelines for electronic records and signatures, crucial for companies in the life sciences industry. This white paper provides a thorough assessment of the regulation, highlighting the necessary security, traceability, and operational controls for compliance. Key topics include: Download the white paper to explore how your organization can maintain […]

This White Paper delves into the essential role of temperature mapping in ensuring pharmaceutical and life science organizations uphold stringent storage conditions. Through expert insights and a detailed guide, it underscores how strategic temperature mapping is crucial for compliance with regulatory standards and optimizing storage environments, thereby guaranteeing the utmost in product safety and effectiveness. […]

This white paper explores the pivotal role of Critical Airflow Visualization (CAV) in safeguarding pharmaceutical manufacturing. Through advanced smoke study techniques and the innovative Live-Stream system, it highlights how CAV is essential for effective contamination control, regulatory compliance, and optimizing cleanroom environments, ensuring the highest levels of product safety and integrity. Fill out the form […]

This white paper highlights how visual inspection safeguards pharmaceutical quality and safety through non-destructive testing, preventing defects and ensuring compliance. It discusses current validation methods and future tech advancements for enhanced safety and brand protection. Fill out the form below to have “The Importance of Visual Inspection in FDA-Regulated Industries” sent straight to your inbox. […]

This white paper explores the growing adoption of Automated Storage and Retrieval Systems (AS/RS). AS/RS systems offer space-efficient pallet storage and real-time tracking, revolutionizing inventory management. It also discusses Performance Validation’s innovative solutions for addressing the unique validation challenges posed by AS/RS systems. Fill out the form below to have the “Automated Storage & Retrieval […]

This white paper emphasizes the critical role of computer systems in FDA-regulated industries, highlighting their benefits and risks. It discusses the importance of validation and maintenance for compliance and patient safety while comparing Computer System Validation (CSV) and Computer Software Assurance (CSA) approaches. Fill out this form to have “Comparative Analysis of CSV and CSA […]

One common question asked by companies with rooms, buildings, or other enclosures with Heating, Ventilation, and Air Conditioning (HVAC) requirements is, “At what point does an excursion outside the specified range need to be logged?”

Software as a Service (SaaS) is growing in demand more each year with the evolution of cloud services and the lack of capital budgets for on-premise deployments. Software as a service features a complete application offered as a service on demand.

The purpose of this white paper is to provide the life science industry with an approach to process validation that provides a method to identify what variables exist in the process, which variables exhibit dominance, and control methods to minimize process variability using the concepts of Dominance as described by Dr. Juran.