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EduQuest-ions and Answers Information Center. Q&A with the FDA Compliance Professionals at EduQuest. FDA Compliance, Inspection Preparedness Library. Electronic Signatures: When to Notify the FDA. January 16, 2014. Q: Does my company need FDA approval to start using electronic signatures? A: No, but you do need to notify FDA of your intentions. Under 21 CFR Part 11.100 (c), you must certify to FDA that your personnel understand that their electronic…. Read more →. FDA Requirements for Source Data. Managi...
Auditing Archives - EduQuest-ions & Answers Information Center
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EduQuest-ions and Answers Information Center. Q&A with the FDA Compliance Professionals at EduQuest. FDA Compliance, Inspection Preparedness Library. Tag Archive for Auditing. CAPA Data Sources; What Makes a Compliant CAPA System. June 24, 2016. Bull; 0 Comments. Q: My question is about what makes a compliant CAPA system, including appropriate CAPA data sources. We recently received a 483 notice citing inadequacies in our CAPA system. Could you review for me FDA’s basic requirements for CAPA? May 17, 2016.
Audit Trail Archives - EduQuest-ions & Answers Information Center
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EduQuest-ions and Answers Information Center. Q&A with the FDA Compliance Professionals at EduQuest. FDA Compliance, Inspection Preparedness Library. Tag Archive for Audit Trail. Part 11 Password Safeguards: What’s Really Required? May 17, 2016. Bull; 0 Comments. Read more →. SharePoint Validation: What’s FDA’s Latest Position? March 3, 2016. Bull; 0 Comments. Read more →. Objective Evidence: How to Document It to FDA’s Satisfaction. February 26, 2016. Bull; 0 Comments. A: First of all, remember that obj...
Audit Report Archives - EduQuest-ions & Answers Information Center
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EduQuest-ions and Answers Information Center. Q&A with the FDA Compliance Professionals at EduQuest. FDA Compliance, Inspection Preparedness Library. Tag Archive for Audit Report. Re-Audits: When and Why Should You Conduct Them? March 15, 2016. Bull; 0 Comments. 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? Read more →. February 23, 2016. Q: I’ve ...
Annex 11 Archives - EduQuest-ions & Answers Information Center
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EduQuest-ions and Answers Information Center. Q&A with the FDA Compliance Professionals at EduQuest. FDA Compliance, Inspection Preparedness Library. Tag Archive for Annex 11. Regulated Software and Systems: What FDA Expects to See. July 20, 2016. Bull; 0 Comments. Read more →. Part 11 Password Safeguards: What’s Really Required? May 17, 2016. Bull; 0 Comments. Read more →. Validating an HR-Related System: What Would FDA Say? March 15, 2016. Bull; 0 Comments. Q: We’re having an internal debate about vali...
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EduQuest-ions & Answers Information Center - Q&A with the FDA Compliance Professionals at EduQuest
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