Q: At our company, we don’t have an issue with validating production software or firmware, but we do make improvements to software and firmware on the production floor. Do you have any insight as to when and if FDA expects prior…
Tag Archive for verification
Data Warehouses and Business Intelligence Software: Tips for Validation
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Q: How should we go about validating data warehouses and business intelligence systems? I understand that any regulated source systems would, of course, need to be validated individually. But how do you validate the data that has been extracted, transformed and…
Product Risk Assessment Basics: Continually Collect Data, Update Documentation Often
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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…
Guidelines for Making Quality System Changes
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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?
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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?
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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?
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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?
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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?
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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
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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…