Are the observations/findings registered only in the CAPA?
No, the findings and observations are registered in the audit under the findings tab. They are attached to the actual internal audit being conducted. Another point is that a CAPA needs to be generated to close the finding. However, the finding is registered under the audit itself.
Does the KPI utilize AI to predict aspects of your QMS?
Yes, we have implemented AI within the KPI tool to provide you with this advantage. For example, it focuses on showing you overdue items or expired documents, trainings, and tasks. In the events tab, there is an AI engine that analyzes your historic QMS data and behavior to predict which events are highly likely to go overdue based on factors such as assigned personnel, event type, criticality level, and historical trends. Scilife will alert you about elements with a high probability of becoming overdue, even if the due date is in the future.
What happens if you close the CAPA from the Deviation but the investigation is still ongoing?
Scilife monitors everything. If you attempt to close the CAPA while there is still an ongoing investigation, the system will permit it but will issue a warning about the linked open investigation. It will prompt you to confirm your decision and electronically sign, in accordance with 21 CFR Part 11, while also requiring you to provide a reason. This information, including the signature and reason, will be logged in the audit trail so auditors can understand why the CAPA was closed before the investigation concluded.
How should an audit where the auditee fails to provide all relevant documents required be handled?
When the auditee fails to provide all relevant documents required during an internal audit, it may indicate that the auditee is not adequately prepared. There could be various reasons for this, such as lack of preparation, inadequate training, or lack of experience. To address this, the internal auditor should request the auditee to gather and organize the necessary documentation in advance of the audit.
What are the requirements for maintaining auditor qualification?
The requirements for maintaining auditor qualification include having sufficient scientific, technical, and practical experience to conduct thorough audits within the planned scope. Auditors must remain competent and up-to-date with current standards and regulations through continuous professional training, education, and development activities. They should be evaluated on their knowledge of standards, regulations, and auditing techniques. Auditors are also required to obtain auditor certifications and pass recertification examinations at regular intervals to demonstrate ongoing competency.
You showed a Risk Assessment linked to an investigation of a Deviation. Can you perform a Risk Assessment that isn't linked to a quality event?
Yes, you can create standalone Risk Assessments in addition to those linked to any Scilife item.
Can you view a full list of all maintenance tasks for your equipment, or only the overdue ones?
Yes, you can view all scheduled maintenance tasks for a piece of equipment or even export the full list of equipment and tasks.
