Reasons for CI CFFs in regulated environments
| Reasons for CI barriers in regulated environments | Strongly agree | Agree | Neither agree nor disagree | Disagree | Strongly disagree |
|---|---|---|---|---|---|
| Fear of extra validation activity | 39% | 34% | 11% | 7% | 0% |
| Compliance vs quality (closing issues/investigations within deadlines) | 27% | 27% | 9% | 7% | 0% |
| Regulatory culture of being “safe” | 20% | 20% | 18% | 9% | 0% |
| Overdependence on a continuous improvement owner/department to drive program | 20% | 14% | 25% | 9% | 0% |
| Changes seen as potentially affecting compliance to regulations | 18% | 32% | 11% | 11% | 0% |
| Fear of extra regulatory submission workload | 16% | 36% | 9% | 11% | 0% |
| CI seen as a quality department. initiative | 16% | 11% | 16% | 16% | 7% |
| Lack of training | 11% | 34% | 16% | 11% | 0% |
| CAPA seen as unwanted extra work | 11% | 39% | 11% | 7% | 0% |
| Regulatory department do not see benefits | 9% | 25% | 14% | 7% | 18% |
| Lack of management support | 7% | 25% | 25% | 11% | 2% |
| Heavy external audit schedule limits time for CI | 7% | 25% | 11% | 2% | 0% |
| Reasons for CI barriers in regulated environments | Strongly agree | Agree | Neither agree nor disagree | Disagree | Strongly disagree |
|---|---|---|---|---|---|
| Fear of extra validation activity | 39% | 34% | 11% | 7% | 0% |
| Compliance vs quality (closing issues/investigations within deadlines) | 27% | 27% | 9% | 7% | 0% |
| Regulatory culture of being “safe” | 20% | 20% | 18% | 9% | 0% |
| Overdependence on a continuous improvement owner/department to drive program | 20% | 14% | 25% | 9% | 0% |
| Changes seen as potentially affecting compliance to regulations | 18% | 32% | 11% | 11% | 0% |
| Fear of extra regulatory submission workload | 16% | 36% | 9% | 11% | 0% |
| CI seen as a quality department. initiative | 16% | 11% | 16% | 16% | 7% |
| Lack of training | 11% | 34% | 16% | 11% | 0% |
| CAPA seen as unwanted extra work | 11% | 39% | 11% | 7% | 0% |
| Regulatory department do not see benefits | 9% | 25% | 14% | 7% | 18% |
| Lack of management support | 7% | 25% | 25% | 11% | 2% |
| Heavy external audit schedule limits time for CI | 7% | 25% | 11% | 2% | 0% |
Sharing content requires targeting cookies to be enabled. Please update your cookie preferences to use this feature.