PMOD Quantification
PMOD for Contract Research Organizations
- Adding strict access control and tracking of operations to the PMOD toolkit
- Supporting a 21 CFR part 11-compliant workflow (i.e. US FDA requirement for clinical trials)
- Access control - login with Active Directory, controlled access to project databases
- Procedure logging -
- Trusted tools – the comprehensive functionality used in hundreds of publications per year
- Enterprise scalability – centralized Scientific Data Management System, as many concurrent users as you need to drive your projects
- Audit trail – full access control and tracking of operations, database-based audit trail to support a 21 CFR part 11 compliant workflow
- Operation time - date and time of performed operation (local computer time)
- User - user name
- Module - module name in which operation was performed
- Level - level of operation (from general System to data Image/Component level)
- Operation - type of operation
- Subject name - name of the subject if data operation is performed
- Subject ID - ID of the subject if data operation is performed
- Complex DBID - database identifier
- Details - descriptive details of the operation
- Additionally operations on the images are traced in the Image History.
- Configuration changes
- Modules access (start/exit)
- User login/logout
- Data access (load/save)
- Operations that change data or produce a new data
