Compliance Gurus had the unique opportunity to work with a small medical device company located in Massachusetts. The company was faced with many challenges. The first challenge was they wanted to get their product on the shelves of a major retailer. However, in order to do so, they had to pass a series of GMP audits by a third party contracted out by the retailer. Compliance Gurus Inc. was called in at this point to help assess and prepare for the audit. The second challenge the company faced was they had no QA department and very little understanding of the Code of Federal Regulations, especially 21 CFR Part 820. The third challenge the company faced was a lack of resources. These three challenges combined, made the task at hand seem impossible at first.

Like so many small to medium sized companies, a QA department doesn't exist, nor does the company understand they are required to comply with aspects of the Quality System Regulation, 21 CFR Part 820. In some events, the QA Department consists of one individual that reports up into operations. Unfortunately, this is not considered an independent QA unit (QAU) so this poses a risk to an organization, as it jeopardizes the integrity of the QAU. In any event, in this case, there was no QAU, therefore, the company had to find a Quality Assurance function without having to hire a full-­‐time employee. Subsequently, the company decided to outsource their Quality Assurance function to Compliance Gurus Inc.(CGI).

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