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…
What are Considered “Work Operations” under FDA’s CAPA Rules?
Q: 21 CFR Part 820.100(1) says we should establish and maintain CAPA procedures with requirements for “analyzing processes, work operations…” Does “work operations” mean operations of processes? Should we determine criteria and methods to ensure that our “work operations” are effective?…
FDA Rules for Tracking Exchanged Parts: Are You Servicing, Remanufacturing, or Refurbishing?
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?
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?
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…
Design Validation: More than Just User Testing
Q: Really, in the final analysis, isn’t design validation just user testing? A: I’ve heard that a lot lately. But it’s not true. The Quality System Regulation (21 CFR Part 820) includes requirements for design controls. The regulation requires design validation…