| Resource | Computer System Validation Issue Log | dbartel |
| Resource | Computer System Validation Course Presentation | dbartel |
| Poll | Which of the following is not a risk assessment methodology mentioned in ICH Q9, Quality Risk Management? | jmorris |
| Resource | Pfizer, 5/10 | dbartel |
| Resource | Medtronic Navigation, 5/10 | dbartel |
| Resource | Baxter Healthcare, 6/10 | dbartel |
| Resource | Wayne State University IRB, 4/10 | dbartel |
| Resource | Optovue, 6/10 | dbartel |
| Resource | AVEVA Drug Delivery Systems, 5/10 | dbartel |
| Resource | Children’s Hospital Association Transfusion Medicine Services, 4/10 | dbartel |
| Poll | Per FDA Guidance, you "should consider auditing the vendor’s _________ used in construction of OTS (off the shelf) software” | jmorris |
| Resource | Validation Protocol - OQ or PQ | dbartel |
| Resource | Deitz MD, 4/10 | dbartel |
| Resource | Chawla MD, 3/10 | dbartel |
| Resource | 3CPM company, 3/10 | dbartel |
| Resource | Oympus Temmo Biomaterials, 2/10 | dbartel |
| Resource | Interacoustics A/S, 12/09 | dbartel |
| Poll | For spreadsheets, which of the following 21 CFR Part 11 electronic records requirements is the most difficult to meet? | jmorris |
| Resource | Ohm Laboratories, 8/09 | dbartel |
| Resource | Toledo MD, 3/10 | dbartel |
| Resource | FDA 21 CFR 820: Quality System Regulation | dbartel |
| 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 |
