Q: I’ve been assigned to do a product risk assessment on a new device we’re developing. My background is not in risk management, so any advice you can offer would be very much appreciated. I’m especially concerned about how often we…
Tag Archive for verification
Guidelines for Making Quality System Changes
• 0 Comments
Q: I think we understand what’s required for changes to a product design or manufacturing process. But when it comes to making changes to a quality system procedure or work instruction, we’re not clear on what’s needed prior to implementing such quality…
Can You Trust E-Signatures from Your Software Package Vendor?
• 0 Comments
Q: I have concerns about e-signatures supplied by a software vendor. Our company is using a Quality Management System (QMS) supplied by a software vendor who provides a validation package. The package shows how the QMS was validated, and the documents…
Can Characterization Substitute for Design Verification?
• 0 Comments
Q: We have characterized a material change to our medical device and have confirmed there’s no impact to any of our design inputs or outputs. Do we still have to formally perform Verification and Validation (V&V)? In other words, is the…
Re-Audits: When and Why Should You Conduct Them?
• 0 Comments
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…
Process Control Rules: What’s the Difference Between Qualified and Trained Personnel?
• 0 Comments
Q: I have a question about FDA’s process control and training rules. The “Production and Process Controls” section of FDA’s Quality Systems Inspection Technique (QSIT), says the FDA investigator should “Verify that personnel have been appropriately qualified to implement validated processes…
FDA Requirements for the Device Master Record: What Should You Include?
• 0 Comments
Q: I’d like you to clarify whether or not we should include verification and validation (V&V) information within the Device Master Record (DMR) for each of our products. 21 CFR 820.181(c) says the DMR should include quality assurance procedures, including acceptance…
Supplier Audits: Tips for Evaluating Suppliers Not Familiar with FDA Expectations
• 0 Comments
Q: I’ve been added to my company’s team to perform supplier audits of some potential new vendors and contractors. Some of their facilities have not done work previously for an FDA-regulated company like ours. One of our biggest concerns is whether they…
Tips for Obtaining Objective Test Evidence: Document What You Observe
• 0 Comments
Q: When testing an Interactive Voice Response System (IVRS) for deployment, what method would you recommend for obtaining objective evidence of the failure test steps? These are steps where you intentionally enter erroneous data to test the IVR’s edit checks.…
Design Changes: When It’s OK to Verify but Not Validate
• 0 Comments
Q: My colleagues and I are having a discussion about design changes. We have characterized a material change to our medical device and have confirmed there’s no impact to any of the product’s design inputs or outputs. In this case, do we…