Q: Are there any FDA regulations or requirements that cover the tracking and recording of exchanged parts used in equipment such as medical devices? A: The current answer depends on whether you are servicing the device, remanufacturing it, or refurbishing it. If…
Tag Archive for records
Mobile Apps for Clinical Use: Any Special Rules or SDLC Modifications?
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Q: For electronic methods of collecting clinical investigation data with a mobile application, should we have any special concerns? For example, what additional controls should we consider during the development and validation activities, compared to our existing system development life…
Generic Logins: OK for SOPs and Forms on the Production Floor?
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Q: I have a question about generic logins. We’re getting computers on our production floor. Some colleagues have suggested we allow one generic login for all production personnel to view and print SOPs (with a watermark) and also to print the…
FDA Outsourcing Rules: Do They Cover More than Contract Manufacturers?
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Q: Question about FDA outsourcing rules: ISO 13485 requires that when an organization chooses to outsource a process that affects product conformity with requirements, the organization must ensure control over such processes. It also says that control of outsourced processes should…
Audit Trails: OK to Generate Reports from a Back-End Database?
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Q: I have a question and look forward to an answer from the FDA experts. 21 CFR Part 11 Subpart B 11.10 (e) states “Such audit trail documentation…shall be available for Agency review and copying”. For our clinical trial activities, we…
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…
SOUP: FDA’s Recipe for Open Source Software
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Q: Is it acceptable by FDA to use open source software for low critical applications? These applications do not have a direct impact on patient safety but are used to support GxP activities. An example would be a software testing tool.…
Incoming Inspection: Is Pass/Fail OK?
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Q: At my company, incoming inspection includes measuring the length of a cable used in our products. The results are recorded as “pass/fail”. My colleague thinks the actual results (the measurement) should be recorded instead. I can’t recall an actual regulation…
Part 11 Password Safeguards: What’s Really Required?
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Q: My question concerns the requirement for Part 11 password safeguards (Part 11.300(d)) that prevent unauthorized use of passwords or identification codes. We’ve always considered the “detect and report” portion of this requirement to include logging unsuccessful attempts and then reviewing those…
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…