White Papers

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.