Recent posts

TypeTitleAuthorRepliesLast Post
PollWhen performing a quality risk assessment for a software application, which of these hazards would be rated the most critical? jmorris02 days 10 hours ago
ResourceCardiac Science, 2/10 dbartel06 days 7 hours ago
ResourceXian Libang Pharmaceutical, 1/10 dbartel06 days 7 hours ago
ResourceOhm Laboratories, 12/09 dbartel06 days 7 hours ago
PollIf your company is the subject of a software quality audit, which of the following would you NOT do? jmorris05 weeks 2 days ago
ResourceSOP Document Management dbartel05 weeks 3 days ago
ResourceCrothal Healthcare, 12/09 dbartel05 weeks 3 days ago
ResourceSunrise Pharmaceutical, 01/10 dbartel05 weeks 3 days ago
ResourceGazda MD 11/09 dbartel05 weeks 3 days ago
ResourceSibley Memorial Hospital, 12/09 dbartel09 weeks 2 days ago
ResourceEndotech, 10/09 dbartel09 weeks 2 days ago
PollPIC/S provides an internationally harmonized cGXP inspection framework. Besides the US, which other country is not a member? jmorris013 weeks 2 days ago
ResourceArnold Tuber Industries, 11/09 dbartel013 weeks 3 days ago
ResourceSpreadsheet Validation Template dbartel015 weeks 4 days ago
PollAccording to the FDA and IEEE, “Risk” is a measure of the _______ and the _______ of the undesired effect. jmorris018 weeks 1 day ago
ResourceCare-Tech Labs, 5/08 dbartel018 weeks 4 days ago
ResourceFDA Draft Guidance: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices dbartel018 weeks 5 days ago
ResourceFDA Draft Guidance: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data dbartel018 weeks 5 days ago
ResourceWeartech International, 9/09 dbartel019 weeks 1 day ago
ResourcePhoenix Bio-Tech, 10/09 dbartel019 weeks 1 day ago
ResourcePhoenix Medical Devices, 9/09 dbartel019 weeks 1 day ago
PollWhich of the following FDA regulated industries receives the most computer system related citations in Warning Letters? jmorris022 weeks 2 days ago
ResourceCooley Dickinson Hospital, 8/09 dbartel023 weeks 2 days ago
ResourceCambrex Profarmaco Milano, 8/09 dbartel023 weeks 2 days ago
ResourceBiomed Devices, 2/09 dbartel023 weeks 2 days ago