Savings of over $100K in 3.5 hours

We were contacted by an outsourcing laboratory that 1) wanted an interpretation of a finding provided by a potential client but which included no detail, and 2) needed to understand what business ramifications might apply. With no advanced preparation, familiarization with the issue or additional information, and within 3.5 hours, we

• Gained an understanding of the laboratory’s processes and
• Explained the nature/intent/likely resulting outcome of the finding.

Furthermore, we were able to

• Provide a detailed roadmap to follow in order to document the work-arounds/controls that are in place to ensure data quality and integrity and
• Identify additional operational risks and regulatory compliance gaps in the current process that were initially overlooked.

And, as if these things alone were not valuable enough, the highlight of our 3.5 hour visit was helping the laboratory save over $100K in projected expenses; whereas the laboratory was considering a major capital expense to overcome some of the operational and regulatory compliance gaps, we outlined a defensible mitigation strategy based on utilizing, compiling and documenting information already available. If this is not viewed as a practical approach to problem solving, then little of anything else would be.