Can you define different levels of criticality for findings in an audit?
Yes, you have the option to set up your own different types of findings in the module settings. In our case, we have critical, high, medium, low, and recommendations. You can categorize them and even make it mandatory to open quality events, CAPAs, and risk assessments based on their criticality. For high critical findings, you might require that a non-conformity is open, a CAPA is open, and a risk assessment is created. For recommendations, it might be just a finding that someone can close without the need for additional actions.
If I would like to learn more about the risk assessment tool, how can I do it?
You can find plenty of information about the risk assessment tool on our website. If you need further assistance or want a demonstration, feel free to book a meeting with our Product Specialist. The risk assessment tool is quite powerful and might warrant a dedicated session to explore its capabilities.
Instead of issuing a deviation, can we do a risk assessment for an audit observation?
Yes, you can choose to perform a risk assessment instead of issuing a deviation. It depends on how you set up the different types of findings. If you configure the system to allow risk assessments for specific findings, you can skip the deviation and directly proceed to the risk assessment. From there, you may choose to open a CAPA based on the risk assessment's results.
What is the retention period of documents and records in SciLife?
In Scilife, there is no limit or specific retention period for documents and records. The system is 21 CFR Part 11 compliant with electronic records. This means that your decision on how to maintain records should be based on predicate rule requirements and that you base your decision on a justified and documented risk assessment. You should determine the value of the records over time in line with current regulations. However, note that nothing is deleted permanently in Scilife. Even if you delete a document, it will be stored in the deleted items section along with the entire history of versions. Similarly, the audit trail is always stored, even for deleted documents. This ensures that all data remains accessible and traceable indefinitely.
When reviewing and updating a document, is it mandatory to have retraining of all relevant users?
No, it is not mandatory to retrain all relevant users when reviewing and updating a document. When you approve a document after the update, there is a small checkbox that allows you to decide whether this update triggers additional training or not. If the revision is minor and doesn't require retraining, you can exclude it from the training process.
You're also integrating a risk assessment tool. What is the structure recommended in GLP flow for this?
The recommended structure for conducting risk assessments in the GLP (Good Laboratory Practice) flow is to use tools like FMEA (Failure Mode and Effect Analysis). FMEA is based on identifying hazards and risks and evaluating and calculating the risk priority number (RPN) based on severity, probability, and detectability. This helps in prioritizing risks and developing a mitigation plan. Scilife integrates FMEA and other risk assessment tools, making it easier to perform comprehensive risk assessments within the system.
