Traceability

Traces are what ties your Design Controls together and drive your Design forward. It demonstrates the dependencies in your design.  

Aligned Elements provides multiple ways to set traces, each way optimized to a particular working context. The traces can be set 1 : 1, 1 : N, N : 1or N : N, between any Item types.

In this way, you can not only define a requirements traceability matrix (RTM) but customize your traceability matrices according to standards such as IEC 62304, IEC 62366, ISO 14971 as well as according to your own QMS.

Modifications to Design Control Items highlight surrounding traces to indicate that further actions to related Items might be necessary as a consequence of the change. 

Real-time trace analysis of any selected Item-set immediately reveals any missing or inconsistent traces which can quickly be resolved.

Trace Analysis can be done on incoming and outgoing traces including, looking for types and numbers of traces including search down any number of levels in the trace chains.  

The built-in Trace Table Designer can be used to build your own customized trace tables on-the-fly.

Run the trace tables and inspect the results as a traceability matrix, make modifications to the table design, or go straight to the Document Objects to set and remove traces.

The traceability matrix can also be exported as Word Trace Table Template to be used for Trace Table export in Word.

Aligned Elements Word integration permits instant creation of multi-column trace reports with customizable look-and-feel.

The synchronizable traceability matrix in documents can be updated to the current database state with a single click.

Rich display of Design Controls and their traces dependencies can be depicted in any number of variants.