Is it possible to define the control range for maintenance or calibration tasks?
Yes, you can program the control range for maintenance or calibration tasks in the system. You have options to set it to repeat daily, weekly, monthly, annually, or a custom range. For example, you can set it to repeat every two months and specify when it ends or if it never ends.
Is it possible to define mandatory fields in the events module?
Yes, it is possible to define mandatory fields in the events module. When creating custom fields in the module settings, you have the option to mark them as mandatory or optional. This allows you to customize the fields and specify whether certain information must be provided or not for the events.
Are IDs generated by the system, or can you define your own structure for event risk assessments?
The IDs for event risk assessments are generated by the system but based on defined prefixes. You can define these prefixes for each event type, risk assessment type, or equipment type. The system will assign a correlative number to the prefix you define, ensuring unique identification for event risk assessments.
Is it possible to define detailed tasks for specific actions, particularly in CAPA?
Yes, it is possible to define detailed tasks for specific actions in Corrective and Preventive Action (CAPA). you can provide detailed descriptions and complementary files for the tasks. You can also assign due dates and responsible individuals to the tasks to manage them effectively.
Can the program be used for GMP equipment?
Yes, the solution is suitable for GMP (Good Manufacturing Practice) equipment. It has been validated and is compliant with regulations such as 21 CFR Part 11 and Annex 11 from the EU. The system offers access control, an audit trail, and timestamps for tracking changes and ensuring compliance with GMP regulations.
If a maintenance task is completed after the scheduled date, does the next scheduled date move forward?
If a maintenance task is completed after the scheduled date, the next scheduled date will remain the same initially. However, you can manually modify the next scheduled date if needed. The system will notify responsible individuals and managers about any delays, and there will be an escalation process to ensure timely completion of tasks.
Is it possible to have some supervisor (ideally QA) after closed maintenance and calibration tasks?
Yes, you can set the option to have QA to approve every maintenance and calibration task once it is closed by the task executor.
How will people know if they need to complete maintenance tasks? Can a manager see these tasks and is there escalation in case that person is late?
Notification of assignment of task will be sent by email, but also will appear in that user’s dashboard. They will also see it in their Dashboard calendar. Responsible user (manager) will also be informed and can also check from the list page, where they can export all maintenance tasks with their dates. Finally, through the KPI tool it is possible to have real time information about Equipment maintenance as well.
Is there a workflow for approving or qualifying equipment?
Yes, Equipment has its own workflow that allows you to qualify your equipment. You can also link to Documentation that you can create and maintain in Document Control for qualification protocols and reports.
Apart from the report option, is there some sort of log or audit trail to control equipment?
Yes, Equipment solution has an audit trail functionality for each equipment. You are able to track any activity, the person responsible for the action, time and date.
Is the system able to support similarly other risk assessment tools, like presented FMEA?
The system is able to support FMEA and FMECA tools. Scilife is adding other tools to the platform as well.
