| Poll | When performing a quality risk assessment for a software application, which of these hazards would be rated the most critical? | jmorris |
| Resource | Cardiac Science, 2/10 | dbartel |
| Resource | Xian Libang Pharmaceutical, 1/10 | dbartel |
| Resource | Ohm Laboratories, 12/09 | dbartel |
| Poll | If your company is the subject of a software quality audit, which of the following would you NOT do? | jmorris |
| Resource | SOP Document Management | dbartel |
| Resource | Crothal Healthcare, 12/09 | dbartel |
| Resource | Sunrise Pharmaceutical, 01/10 | dbartel |
| Resource | Gazda MD 11/09 | dbartel |
| Poll | Per FDA guidance, when implementing purchased software, vender supplied software requirements, test protocols, & results ______. | jmorris |
| Resource | Sibley Memorial Hospital, 12/09 | dbartel |
| Resource | Endotech, 10/09 | dbartel |
| Poll | PIC/S provides an internationally harmonized cGXP inspection framework. Besides the US, which other country is not a member? | jmorris |
| Resource | Arnold Tuber Industries, 11/09 | dbartel |
| Resource | Spreadsheet Validation Template | dbartel |
| Poll | According to the FDA and IEEE, “Risk” is a measure of the _______ and the _______ of the undesired effect. | jmorris |
| Resource | Care-Tech Labs, 5/08 | dbartel |
| Resource | FDA Draft Guidance: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices | dbartel |
| Resource | FDA Draft Guidance: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data | dbartel |
| Resource | Weartech International, 9/09 | dbartel |
| Resource | Phoenix Bio-Tech, 10/09 | dbartel |
| Resource | Phoenix Medical Devices, 9/09 | dbartel |
| Poll | Which of the following FDA regulated industries receives the most computer system related citations in Warning Letters? | jmorris |
| Resource | Cooley Dickinson Hospital, 8/09 | dbartel |
| Resource | Cambrex Profarmaco Milano, 8/09 | dbartel |
