GxP System Validations

Another long-running detail of my career is that I've mostly worked in biotech / pharmaceutical environments.  As you can expect, these are pretty heavily regulated areas, with some regulations being just as strict as those in the financial industry.   Here are some of the validation focused projects I'm most proud of.

Company: PolarityTE - Salt Lake City, UT
Overview: In support of company-wide efforts to begin* commercial production of our product, I worked with the Manufacturing team, QA, Executive Management, and my IT colleagues to develop a series of validation packages that integrated with our existing quality system.   

• Worked with team to author risk assessments for both cleanroom manufacturing systems and QC Laboratory testing systems.
• Using these risk assessments, I wrote single-document system and business requirements for each of the relevant systems.
• These requirements documents were then used to generate a validation plan for each system.  These plans included the previously created risk assessment and requirements docs, and were joined by a validation overview document (almost a table of contents for the package), test scripts, and upon the completion of the validation process, a report was included to describe the entire process and results.
• Following approval of the document packages in our MasterControl document management system, I entered the cleanroom and executed the test scripts for the associated machines.  I only mention this because it was kinda cool to try to generate enough dust in the sealed RABS (inside a cleanroom) to set off a particle counter's alarm.  

Company: Nektar Therapeutics - Multiple Global Locations
I can't really break Nektar's validation projects down into concise bullet points, as I was involved with Nektar's validation initiatives for well over a decade.  

Examples of systems I helped validate at Nektar:

• The "Manufacturing Control Network" (MCN) at the San Carlos facility was my first introduction to the concept of validation, circa 2004.   This was an isolated LAN with four redundant servers, multiple human-machine interface (HMI) kiosks, and a tape-based backup system.  This environment ran the process controls for a large-scale clinical manufacturing operation.  
• Multiple HPLC systems - I handled a lot of the network and infrastructure side of validating these systems, which were used in both clinical and commercial testing laboratories.   

IT Qualification

In the Nektar IT department, we used a mostly custom IT Quality System which ultimately tied in / reported up to the corporate QA Quality System.   This IT Quality System described the creation and management of "System Implementation Packages" (the name changed periodically) for each "system" managed by the IT team.   Our level of qualification was at the same strict standard as the validation processes we'd perform on required systems.  As a result, effectively most of the business systems in use by the company were managed as if they were validated.  This doesn't sound really great in text, but if you ask me about it on a video session, I'd love to rap more about it.  Also if John is reading, dude, we griped and grumbled about that quality system at the time but it was SOOO GOOOD, so thank you for your leadership in letting us tweak it to our needs instead of dumping it entirely.