The Practical Solutions Group was retained by an early-stage company, with a niche service offering, to assist in developing the quality infrastructure for their operations. The effort involved two intensive months, at which time the company was notified by a new and, potentially their largest, client that a vendor assessment was in the offing.
We helped our client to prepare a presentation describing their service, laying out the work flows and supporting documentation, clarifying the company's classification in the regulatory arena and identifying regulations which pertain to the operations and those which do not. Additionally, we documented the fact that there were no records that were within the scope of 21 CFR part 11. This allowed the auditor to focus attention on critical processes and operational steps, which, in turn, reduced the time of the audit from two days to one day.
In advance of the audit, we made our client aware of two issues that might result in observations. To soften the impact, we helped the client to prepare plans, prioritize the necessary tasks, assign responsibilities, identify completion dates and create a system to document the progress.
The client asked us to assess the audit observations and help with drafting the responses. Being confident about the appropriateness of the quality infrastructure, having hands-on experience with applying the regulations, and understanding the risk areas of our client, we recommended the least conservative approach. We did not agree with six of the eight observations and provided supporting information as to why we did not agree. We also suggested wording for the audit responses. Our client's client accepted all of the responses with no further commentary. All of the issues for our client were closed.
The standard, expected and conservative approach of performing all of the suggested tasks (necessary or not), would have cost our client between $10,000 and $15,000 to satisfactorily close all of the outstanding items. Our advice cost less than $1,000. Now, that's some practical savings, not to mention a real practical focus!