Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Does FDA certify electronic systems and methods used to obtain electronic signatures? 1.70K viewsClinical Research 0 Votes 1 Ans Will the FDA cite you for 21 CFR 11 non-compliance? 1.94K viewsClinical Research 0 Votes 1 Ans Does the FDA conduct random 21 CFR 11 only inspections? 1.70K viewsClinical Research 0 Votes 1 Ans Do I need to validate commercial software like Microsoft Word or Excel? 1.49K viewsClinical Research 0 Votes 1 Ans What should sponsors and other regulated entities consider when deciding to validate outsourced electronic services that are used in clinical investigations? 2.06K viewsClinical Research 0 Votes 1 Ans Under what circumstances would FDA choose to inspect the electronic service vendor? 1.74K viewsClinical Research 0 Votes 1 Ans What does Electronic Systems Primarily Used in the Provision of Medical Care ? 1.59K viewsClinical Research 0 Votes 1 Ans What access controls should sponsors implement for mobile technology accessed by study participants for use in clinical investigations? 1.90K viewsClinical Research 0 Votes 1 Ans When using mobile technology to capture data directly from study participants in clinical investigations, how do sponsors identify the data originator? 1.80K viewsClinical Research 0 Votes 1 Ans If sponsors and other regulated entities outsource electronic services, who is responsible for meeting the regulatory requirements? 1.51K viewsClinical Research 0 Votes 1 Ans Should sponsors or other regulated entities establish service agreements with the electronic service vendor? 1.60K viewsClinical Research 0 Votes 1 Ans Does FDA consider it acceptable for data to be distributed across a cloud computing service’s hardware at several different geographic locations at the same time without being able to identify the exact location of the data at any given time? 1.65K viewsClinical Research 0 Votes 1 Ans What should sponsors and other regulated entities have available on site to demonstrate that their electronic service vendor is providing services in accordance with FDA’s regulatory requirements? 1.97K viewsClinical Research 0 Votes 1 Ans Should sponsors and other regulated entities perform audits of the vendor’s electronic systems and products? 1.62K viewsClinical Research 0 Votes 1 Ans Under 21 CFR 11.10(d), what are FDA’s expectations regarding the use of internal and external security safeguards? 1.80K viewsClinical Research 0 Votes 1 Ans Under what circumstances are part 11 requirements not applicable for electronic copies of paper records? 1.86K viewsClinical Research 0 Votes 1 Ans Can sponsors and other regulated entities use and retain electronic copies of source documents in place of the original paper source documents? 1.85K viewsClinical Research 0 Votes 1 Ans Can electronic copies be used as accurate reproductions of electronic records? 1.90K viewsClinical Research 0 Votes 1 Ans Can sponsors and other regulated entities use durable electronic storage devices to archive required records from a clinical investigation? 1.62K viewsClinical Research 0 Votes 1 Ans Does FDA provide preliminary audit service to inspect an electronic system used in a clinical investigation to ensure compliance with part 11 controls? 1.44K viewsClinical Research « Previous 1 2 … 109 110 111 112 113 … 283 284 Next » Question and answer is powered by anspress.net
