The bio technology field requires quality control over constantly changing manufacturing, testing, packaging, and distribution procedures. The FDA constantly monitors every operation. Every procedure from how to test to what is placed on product label is documented in writing from the original and every revision through document obsolesence. In case of FDA investigations or legal actions this document history is crucial.
This multi-user system provided hierachical document tracking by division and function for all employees. This included each person writing, revising, approving, training, and trained on the procedure.
The system provided statistical analysis to determine how often procedures changed. It helped tracked operational problems to document activity. Over 3 work years from design through testing — accomplished in 1 calendar year.