Quality Assurance Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to both established and emerging diagnostic companies. The following case studies describe specific solutions that we have tailor-made for our diagnostics company clients.
A leader in molecular diagnostic innovation needed to review their Document Control System. Realizing they 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 their system to identify any existing gaps. This effort included 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.
