Q: Are our quality risk management findings accessible to regulatory agencies? Or are they considered private and confidential company information? A: All quality risk management activities and documentation are accessible to the regulatory authorities. Your company should base its findings on the…
Tag Archive for records
Product Recall Outside the U.S.: Should FDA Be Notified?
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Q: We just had a product recall outside of the United States. What are the implications with FDA — are we required to notify the Agency about a non-U.S. product recall? A: Technically, no. But you definitely should be prepared to answer…
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…
Does FDA Specify Environmental Conditions for Computer Systems?
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Q: Are there FDA guidelines or regulatory requirements for maintaining specific environmental conditions for industrial PCs (HMI, SCADA, DAS, etc.) used in manufacturing operations? If yes, what should be the ideal limits? A: Your question comes from a pharmaceutical perspective but applies…
Re-Qualification: How Often Should You Re-Qualify a Computer System?
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Q: What should be the ideal time period for re-qualification of a computerized system? Is it three years, five years, or something else? I’m a bit confused, as there is no proper guidance available in GAMP5 or other industry guidelines. A: There really is…
SCADA Qualification and Upgrade: Can You Qualify a System While It’s Live and On-Line?
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Q: If we perform a modification to a qualified SCADA (supervisory control and data acquisition) system, can we use the SCADA system while it’s still on-line — and also while we are performing the SCADA qualification? A: The SCADA software manufacturer should…
FDA Rules for Tracking Exchanged Parts: Are You Servicing, Remanufacturing, or Refurbishing?
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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…
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…