Who We Are
In 2014, after a 30+ years, an FDA investigator and compliance officer decided to retire and enjoy some freedom from the working life. However, their leisure was short-lived, as a regulated company placed on Import Alert (IA) by the FDA sought the FDA retiree’s assistance in clearing the IA action. Eager to share their years of experience and knowledge, they successfully resolved the request, which marked the inception of 5Ws. Over the years, the company has flourished primarily through word of mouth, guided by the belief that doing good, honest work attracts more work.
This successful approach prompted 5Ws to bring on several associates with FDA and industry expertise, ultimately leading to a name change. Recently, 5Ws has transformed into 5Ws GxPertise, evolving through a partnership with an ever-growing team of GxP experts who collaborate to offer extensive quality and operational knowledge to clients in need of assistance or additional resources.
5Ws GxPertise embodies the collective expertise and knowledge spanning various GxP disciplines that we bring to the table. While some consultants may focus solely on compliance or operations, we have fused both aspects. Our experts bridge the gap between science and compliance, recognizing the essential balance between business and quality, working harmoniously together.
What’s in a Name
Many have asked about the origin of our name. The actual origin is threefold.
First, auditors can be likened to detectives, continually posing numerous questions, often framed around the essential interrogatives: Who, What, Why, Where, When (and, of course, How – but adding How would have just complicated the name. Keep it Simple!).
When performing investigations, after finding the purported cause, tools are used to drill down to the ROOT cause. One must ask “Why?” over and over and over again until you arrive at the root cause.
Lastly, "GxPertise" symbolizes the expertise and knowledge we bring to the table across various GxP disciplines. While some consultants may specialize exclusively in compliance or operations, we have harmoniously merged the two. Our experts bridge the gap between science and compliance, recognizing the vital balance between business and quality, fostering seamless collaboration between them.