The FDA encourages a risk-based approach and critical thinking in Computer Systems Validation and promotes efficiency. Using digital validation tools and adopting paperless validation helps not only meet FDA regulations but also promotes efficiency, consistency, and audit readiness. “This draft guidance is intended to: Describe ‘computer software assurance‘ as a risk-based approach to establish confidence in the automation used for … Read more
If you have purchased or are planning to purchase a computer system for use in regulated activities, here are some key points to keep in mind. As the regulated company, your responsibilities differ from those of your vendor. There are examples from multiple regulatory documents regarding cloud and SaaS computer systems. 1. You are ultimately responsible (not the vendor) As … Read more
Companies who are are new to computer system validation often ask us whether software validation is required for their specific software or systems. And they often assume that they must validate their entire system. While that assumption makes perfect sense, it is not always correct. More on that in a bit. But first, we must understand what types of systems … Read more
Computer System Validation (CSV) is often referred to as software validation. Regulated companies perform validation projects to prove that their software or system is performing the way it is supposed to work, and not performing in ways that it isn’t intended to work. There are several examples as to why software validation is important. Look at the FDA’s library of … Read more
Computer system and software validation is about the patients and the products we make for the patients. As consumers we want to trust that our medicine, medical devices, instruments our doctors use, and so forth, work the way we expect them to work. There are product recalls for so many things – product recalls for food, toys, and even vehicle … Read more
