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 -
  • Audit log management -


  • 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

PMOD Audit Logs

  • 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.

PMOD Operations Tracked

  • Configuration changes
  • Modules access (start/exit)
  • User login/logout
  • Data access (load/save)
  • Operations that change data or produce a new data