In regulated industries such as pharmaceuticals and medical devices, document control is a critical component of compliance and...

As the holiday season sparkles with lights and festive cheer, many of us reflect on the year gone by while planning for what lies ahead....

Navigating FDA compliance can feel like a daunting task for small businesses, especially those operating in regulated industries like...

Like everyone else, I attend training events to further my education and growth as an industry leader and as a small business owner. When...

In the pharmaceutical and medical device industries, achieving high-quality standards is just the beginning. The true challenge lies in...

I have written many posts and spoken on many podcasts about the teams within a pharmaceutical or medical device company not working...

Building and maintaining strong relationships with clients is vital in the world of consulting. The foundation of these relationships is...

In the rapidly evolving pharmaceutical and medical device manufacturing industry, maintaining the highest quality standards is essential....

Preparing for a U.S. Food and Drug Administration (FDA) inspection is a meticulous process that demands a deep understanding of...

Customer complaint data in the pharmaceutical and medical device industries is often treated similarly to other quality systems data,...

In the realm of FDA-regulated products, be it life-saving medications or innovative medical devices, ensuring product safety and efficacy...

In a recent podcast appearance, I discussed quality systems within pharmaceutical and medical device industries. Specifically, I...

My clients hire me to fix their quality systems. I provide them with the tools to implement a strong and efficient process that will meet...

As the holiday season approaches, we are surrounded by festive cheers, twinkling lights, and the joy of giving. It is a good time to...

For FDA-regulated industries, deviations and nonconformances are inevitable challenges. When these issues arise, it is common for the...

In the dynamic landscape of modern businesses, establishing robust quality systems tailored to your unique needs is paramount. These...

My clients ask me to write SOPs all the time. This is one of their biggest headaches that they would like me to alleviate. It takes...

In a previous blog post , I shared that I am an avid knitter. Recently, I completed a cotton summer sweater. Because I am a planner, I...

While I work on many different pieces of the Quality System for my clients, the one that I spend the most time on at Quality Systems...

Most of the calls for help I receive from small pharmaceutical and medical device companies are for SOPs. Their first question is...