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).

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 ...

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 ...

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 ...

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 & ...

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 ...

In this session, experts from Compliance Group and AWS will reveal how Agile CSA (Computer Software Assurance) can transform software validation in the MedTech industry.

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 ...

Staffing supplier quality with expertise in: Supplier Audits, Quality Management Systems, Supplier Training & Development, Software Quality, Validation, Clean Room & Laboratory Services, Manufacturing ...

Because of the rise of data theft and ransomware, data integrity shouldn’t (and can’t) be handled internally alone. Data integrity needs to focus not just on information security, but also eliminating ...

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 ...