How we help

"Up to 60% of products on hold are due to and/or procedural errors."

Our clients are continually faced with resource, workload and time constraints, and lack of a proven approach and methodology to attack the , , and quality system problems resulting in non-conformances

The “band aid” approach is often taken as the corrective action with documentation, procedural, and process non-conformances, and doesn’t effectively address or prevent the incident from happening again.

The reality - corrective modifications become an accumulation of unnecessary content, added steps, and .

The result - Management and supervision continually spend more time and resources on investigations then they do on the manufacturing and releasing of product. The system eventually becomes overloaded with document revisions, repetitive retraining, and unnecessary costs.

business process improvement and redesign solutions assess and identify compliance gaps, unnecessary or redundant data requirements, and steps to improve the overall workflow and work process. Our redesign solution ensures quality issues are resolved and that the , procedures, manual or automated workflow "fits" the process.

Our solutions deliver positive results such as reductions in:

  • Documentation/procedural errors Quality Systems
  • Missing entries
  • Entries/data transactions
  • Time spent on investigations
  • Review cycle time
  • Product release cycle time
  • Time spent on training
  • Document creation/revision time