Join us for a comprehensive 3-day event focused on advancing Computer Systems Validation (CSV), Computerized System Assurance (CSA), and Artificial Intelligence (AI) in the Life Sciences. Learn from ...

Join us for an insightful webinar, “Preparing for FDA Inspections in a Digitalized Landscape: A CSA Perspective,” on November 19, 2024, from 11:00 AM to 12:15 PM (EDT). The panelists of this webinar ...

What exactly is Compliance documentation and how do you know if you are creating clear, concise, accurate content? In the life sciences field compliance documentation is crucial for meeting regulatory ...

Our team will review and confirm that you are from an organization using Polarion. Once your registration is approved, you will receive a confirmation email with the event information. If you are ...

How can we help your organization remove friction and continue your journey to Quality Excellence? Whether you are looking for information or a service quote, submit your information here and our ...

Managing complex projects starts with clear defining goals and aligns with Compliance strategic objectives and workforce planning. Clear understanding of the project requirements and challenges with ...

We are excited to announce that Insulet will host our inaugural Lifesciences Polarion User Group meeting at their headquarters in Acton MA, just outside Boston. Join us for an interactive, educational ...

Khaled Moussally is a highly accomplished executive, results-driven professional with over 27 years of experience in the FDA regulated Industries. As the Executive Vice President of Clients & ...

Join us at GMP University, where excellence in Good Manufacturing Practices awaits! Join us for an enriching 3-day conference and training program crafted to deliver the latest insights and best ...

This comprehensive white paper can be helpful for medical device companies to strategically update their risk management process to not only satisfy the requirements of the 3rd Edition of the ISO ...

Ever-growing customer expectations for innovation amplify the challenges companies face in today’s competitive business environment. While the increased ratio of software in modern products has ...

ISO 14971 is the international standard for risk management, and it guides how to identify,assess, and control risks of an organization. It also provides a framework for managing risks and guidelines ...