We are often asked, “if your clinical trial software is open source, how can it be validated”? The answer is that, like with many other things open source, you have multiple options.
If you choose, you can validate the product yourself from the ground up. This involves defining your requirements, generating and executing test cases that [...]
Filed under: Uncategorized | Tagged: 21 CFR Part 11, GCP, open source, security, validation | Leave a Comment »
