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…
Tag Archive for clinical studies
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…
Is Structured Product Labeling (SPL) Covered under Part 11 Rules for Electronic Records?
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Q: I’ve started to get involved in Structured Product Labeling (SPL) and other electronic methods for submitting documentation to the FDA. I tried asking this question to the Project Manager of SPL, but I didn’t get a confident answer. So I…
Electronic Data Capture (EDC): FDA Expectations for Vendor-Hosted Systems
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Q: Our company uses a vendor-hosted system for Electronic Data Capture (EDC) of clinical trial data. The system is validated under the vendor’s validation lifecycle process, which our company will review and deem acceptable (or not) through our vendor audit…
Electronic Notebook Validation: When Do You Need to Validate Notebooks Used in Research?
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Q: What are FDA’s expectations for electronic notebook validation, including those used by chemists or other scientists in discovery research? A: FDA doesn’t expect you to validate electronic notebooks used strictly for discovery research. However, if you use data from electronic notebooks…
Archiving Training Records
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Q: Can you tell me how long I should keep training records and when to archive them? We manufacture active pharmaceutical ingredients (APIs) with an expiration date of five years. A: The rule of thumb is to keep training records…