Challenge: A leader in molecular diagnostic innovation needed to review its document control system.

Beaufort Solution: Realizing it had insufficient internal resources, the Quality Assurance division sought assistance in transitioning from a paper-based document system to a software-based document control system.  Beaufort performed an initial review of its system to identify any existing gaps.  This effort included a review of approximately 670 SOPs and 350 forms for content including obsolete references; document relevance; assignment of appropriate ownership/responsibility; and potential for SOP deletion, modification, or combination.  In addition, Beaufort worked closely with functional areas to gain an understanding of the numerous processes and how they were potentially linked. This assignment led to a follow-on SOP project.

Date posted: October 27, 2011

Categories: Case Studies Quality Assurance & Compliance