Colgin Consulting, Inc.

In a nutshell, you brought real been there, done that experience which led to a solution that was practical and implementable.

Jamie’s expertise on Good Laboratory Practice (GLP) compliance and Quality Management Systems, both of fundamental importance and necessity in the investigations of the safety and efficacy of drug candidates, enabled my group to leverage her expertise to improve quality and compliance in the research Lab.

As an educator, she is very patient and can masterfully explain things in layman’s terms. As a leader, I value her integrity more than anything else.

One of the few people I know who can make computer validation feel less scary.

“Jamie created an integrated auditing process aligned with department’s internal goals and supplier commitments; benefiting both me and our suppliers and creating harmony between supplier and us.”

By utilizing Jamie’s expertise my team was able to evaluate and select the right vendor, assess and improve systems compliance and quality in the research labs. Her ability to carry out mock FDA, actual inspections, and recurring periodic audits at our facility helped identify shortfalls in compliance, giving us an opportunity to strive for better compliance. Her advice on validation and corrective actions proved to be a key in the success of our system validation program.

Lots of people have subject matter expertise. But the ones that stand out - like Jamie - also have good instincts and get to the heart of an issue without wasting time and resources. I have worked with Jamie for many years and her say-do ratio is a perfect 1.

We found Jamie to have a realistic view of what was achievable in a short period of time as dictated by the sponsor.  Strategizing on a way to hit the timelines was a key contribution that most auditors would not be helpful with.  Jamie sees the big picture around the clinical trial process.

We were initially challenged with getting a new piece of software in place for a global trial.  Jamie was able to facilitate the discussions between sponsor and CRO such that the software could get qualified for worldwide use quickly.

Jamie combines a deep knowledge of Quality, Compliance, and R&D in the Pharmaceutical Industry with the pragmatism necessary to achieve effective business processes AND meet regulatory and quality goals.  This is an all too rare combination.

Executive Director, IT

Our initial project dealt with the development of a complex global system for recording specific data from a large number of departments.  The challenges associated with this project were many but throughout the activity Jamie was thoughtful and constructive in her comments, was willing to listen and develop novel solutions and understood the criticality of the deliverable associated with this project.

The encounter with Jamie changed my life.  When I first met her I was a general GCP auditor.  I joined the Electronic Data Integrity Team lead by Jamie and learned about the world of auditing of computerized systems.  Jamie is not only an experienced computer system validation auditor but also a great leader who motivate the team members.  I learned a lot about the knowledge of 21 CFR Part 11, computer system validation, and auditing of computerized systems from her.  I found that auditing of computer systems was a lot of fun, and that decided me to become a computer system validation auditor in the GCP environment.