Welcoming Robert Perks to the Performance Validation Team 

robert perks image

Performance Validation, Inc. (PV) is thrilled to announce that Robert Perks has joined our team as the new Digital Solutions Director. This strategic addition to our team will significantly enhance our Automation and CSV services, including IT and OT CSV, Process Automation, Paperless Validation, and Digital Transformation initiatives. Robert’s extensive experience and expertise will undoubtedly […]

Read More

Enhancing Efficiency and Effectiveness: The Positive Impact of CSA on CSV Programs 

In the pharmaceutical industry, computerized systems (hardware, software, processes) play a critical role in creating and managing data, producing products, and ensuring compliance with regulatory requirements. 21 CFR Parts 210 and 211 contain aspects which drive the need for computer system validation (CSV). Of course, there is 21 CFR Part 11 (electronic records and signatures) […]

Read More

Streamlining Medical Device Validation: A Risk-Based Approach to Computer Software Assurance

Computerized systems (hardware, software, and processes) play a critical role in the medical device industry. They are used to create and manage data, produce products, and ensure compliance with regulatory requirements.  Computer system validation (CSV) is the process of ensuring that computerized systems meet their intended requirements and can consistently produce accurate and reliable results. […]

Read More

Staff Augmentation for CSV Services: A Cost-Effective Solution for Your Business  

Pharmaceutical manufacturing is a highly regulated industry that requires strict adherence to quality and regulatory requirements. However, staffing shortages or a backlog of projects can put companies at risk of non-compliance and costly delays. In such cases, staff augmentation services can provide an effective solution for pharmaceutical manufacturers to meet their CSV needs. In this […]

Read More

FDA’s Computer Software Assurance Guidelines 

In Food and Drug Administration (FDA) regulated industries, computer systems and software play a critical role in managing data, controlling processes, and ensuring compliance with regulatory requirements. To ensure the safety, efficiency, and quality of pharmaceutical products, the FDA has established specific regulations and guidance documents that outline the requirements for computer system validation (CSV) […]

Read More