How should changes be categorized? Are there any specific guidelines available?
Categorizing changes typically depends on their nature and impact, but it's common practice to classify them as minor, major, or critical changes.
For example, in the case of a weighting balance, the categorization will depend on the impact of the change on the analytical results and the approval of your batch—essentially, its impact on regulatory compliance.
For specific guidelines, most organizations follow industry best practices and international standards like ICH Q10 and ISO 13485, as well as their internal SOPs.
Can the system show which forms and work instructions (WIs) are related to a specific SOP?
Yes, Scilife can link different document types, including forms, work instructions (WIs), and SOPs. When an SOP is associated with a particular process, the system can display all related documents, making it easier to track which documents support the SOP. This ensures complete traceability and simplifies document management.
How do you see the Approved Supplier List?
On the supplier management module list page.
How do we build privileges for CFT users, HODs, and QA?
Scilife manages privileges based on two levels: Permission Roles and Groups. Permission roles can be one of four types: Admin, Manager, Regular, and Read-Only users. This role determines what a user can do in the system, such as create, review, approve, publish, configure settings, create users, define templates, sign off on training, etc. It also allows you to specify whether a user with a certain permission can act in the system as a QA and/or Training Coordinator.
Groups are used to determine what information users can access and in which documents, trainings, events, CAPAs, changes, etc., they can participate actively.
What steps does Scilife take to ensure that Corrective and Preventive Actions (CAPAs) are effectively tracked and implemented?
Scilife ensures effective tracking of CAPAs by integrating them into the change control process. Each CAPA is linked to the related nonconformity and includes timelines, responsibilities, and outcomes to ensure accountability and follow-through. You also have an effectiveness check included in the CAPA workflow.
How does Scilife maintain an audit trail for changes made within the system, and why is this important for compliance?
Scilife maintains a comprehensive audit trail by automatically recording all changes made within the system, including who made the change, what was changed, and when it occurred. This feature is crucial for compliance, providing transparency and traceability.
How does the eQMS manage user access and permissions to ensure that only authorized personnel can initiate changes or access sensitive information?
Scilife has robust user management features that allow organizations to set permissions based on roles and also segregate information by 'groups'. This ensures that only authorized personnel can initiate changes, approve workflows, or access sensitive data, enhancing security and compliance.
What training resources does Scilife provide to ensure users are proficient in utilizing the eQMS for change management and supplier qualification?
Scilife offers various training resources, including online tutorials in the Scilife Academy, Knowledge Base, and live training sessions like our Deep Dives. Support is also available to address any specific questions or issues users may encounter, ensuring they can utilize the system effectively.
How does Scilife leverage data analytics to improve the efficiency and effectiveness of change management processes over time?
Scilife leverages data analytics (KPI module) to monitor change management processes, identifying trends and bottlenecks over time. By analyzing this data, organizations can make informed decisions to continuously improve their processes and enhance compliance.
