Tag Archive for Design control

Re-Audits: When and Why Should You Conduct Them?

Q: What is industry practice — or more importantly, FDA’s viewpoint — regarding re-audits? Do we need defined and documented criteria for when to conduct re-audits? If so, what would such criteria include? A: My experience is that industry rarely does what is…


Objective Evidence: How to Document It to FDA’s Satisfaction

Q: Could you tell me what’s considered best practice when it comes to documenting objective evidence? A: First of all, remember that objective evidence is NOT the words “pass/fail”, “true/false”, “as expected”, or “yes/no”. They are conclusions. [pullquote align=”right” cite=”” link=”” color=”” class=””…


Risk Assessment: When is One Necessary?

Q: Can you tell me when I need to perform a risk assessment?A:  I believe a risk assessment is always necessary. For everything you produce, you should have a product risk assessment that provides you with an understanding of how your product design may impact patients…