Eliminating the Design History File of any gaps and inconsistencies is of outmost importance for all medical device producers. Aligned Elements provides the industry's most extensive range of real-time consistency checks to find irregularities such as:

  • Missing, suspect and illegal traces
  • Insufficiently mitigated risks
  • Unimplemented mitigations
  • Failed tests
  • Unexecuted tests
  • Open deviations
  • Unreviewed items
  • Incomplete E-signatures
  • Items altered after review
  • Items not present in Word documents
  • Outdated items in Word documents
  • Inconsistent item states
  • Overdue dates

The state of your current documentation quality at a glance. The consistency coverage visually summarizes how much work lies ahead before the documentation is ready to be scrutinized by the auditor.

The consistency coverage view gives direct access to the incomplete items and provides a tool-set for solving inconsistencies immediately. 

Consistency checks can be applied as process guidance, triggering on-the-fly checks before saving information.

Set up control rules in workflow transitions to automatically verify that the entered information is consistent with the development process before it is committed.

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