Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How can individually identifiable health information be de-identified? 1.58K viewsHospital and Healthcare 0 Votes 1 Ans Can electronic copies be used as accurate reproductions of paper or electronic records? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to retain paper printouts or static records instead of original electronic records from stand-alone computerized laboratory instruments, such as an FT-IR instrument? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Can electronic signatures be used instead of handwritten signatures for master production and control records? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans When does electronic data become a CGMP record? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Why has the FDA cited use of actual samples during “system suitability” or test, prep, or equilibration runs in warning letters? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to only save the final results from reprocessed laboratory chromatography? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Can an internal tip regarding a quality issue, such as potential data falsification, be handled informally outside of the documented CGMP quality system? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Should personnel be trained in detecting data integrity issues as part of a routine CGMP training program? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the FDA investigator allowed to look at my electronic records? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA recommend data integrity problems identified during inspections, in warning letters, or in other regulatory actions be addressed? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Processes of Complying with Pharmaceutical Compliance? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the Significant Aspects of Pharmaceutical Compliance? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the HIPAA Privacy Rule expand the ability of providers, plans, marketers and others to use my protected health information to market goods and services to me? Does the Privacy Rule make it easier for health care businesses to engage in door-to-door sales and marketing efforts? 1.83K viewsHospital and Healthcare 0 Votes 1 Ans Many of our production processes are documented by means of a batch record on paper. What should we do as concerns the review of the audit trail? Should we review the good documentation practice in the batch record by means of an audit trail review? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans A small filtration facility (pressure measurement/flow measurement/temperature) with a locally installed SCADA system would then rather deliver static data? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an “audit trail”? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA use the terms “static” and “dynamic” as they relate to record formats? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA use the term “backup” in § 211.68(b)? 2.13K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the “systems” in “computer or related systems” in § 211.68? 2.19K viewsDrugsPharmaceutical « Previous 1 2 … 119 120 121 122 123 … 283 284 Next » Question and answer is powered by anspress.net
