Developing My First URS

In 2001, shortly after starting at Gen-Probe in San Diego, the organization asked me to perform a Factory Acceptance Test (FAT) on a filling equipment (See Fig. 1(70 PPM)) that had been ordered without any User Requirements Specification (URS) or other information. Coming from the Entertainment world at Walt Disney Imagineering, I was still learning concepts like FAT. So I worked on the machine for a week and mapped out the Human-Machine Interface (HMI) and figured out how to test the machine thoroughly.

At the time, GAMP was a new concept. No one was sure about how and or what to do with it. It was within this vacuum of industry guidance that I started studying the GAMP process, and from my research and hands-on applications, invented my process and templates.

Refining Templates and Processes

At Gen-Probe, I was able to apply these templates and processes to almost 100 projects and refine them along the way. As the company grew and projects became more complex, so did my sophistication and understanding of what everyone in the process needed.

I created an inquiry process to determine each stakeholder’s needs, from Management to the Operator on the floor. I created the machines’ URS with absolute commitment to eliminate all ambiguities about what the automation should do. In fact, the URS was airtight enough to use it not only as a baseline project tool but also as an automation vendor/quote evaluation tool. In several instances, a vendor declined to quote due to their lack of GAMP documentation support and understanding within their internal system.

Using URS and GAMP Discipline to Qualify New Equipment During COVID

When my company decided that we needed a high-throughput fill machine for the same products that were running on the 70 PPM machine to 200 ppm (see fig’s 2 & 3), I was able to produce the URS for this machine with new and enhanced technology requirements with automated pump calibration and recalibration, 100% fill volume and print vision inspection, 100% torque verification and online instrument validation as well as other improvements to the original process. I then went out to three vendors for quotes. Using the URS and my vendor qualification process, I was able to qualify and choose the right automation partner for the first two machines (one for placement at the company’s UK Facility).

During the machine’s qualification, Covid became a national concern. Hologic was asked to expand production of its related diagnostic products. We finished qualification of the San Diego 200 ppm machine with no change orders in record time and helped with the UK unit to support the pandemic effort. We then placed an order for three more machines for San Diego. Because of the thorough URS and subsequent GAMP documents, they were brought in, qualified and released to manufacturing in record time, with minimal involvement from me, and Hologic was able to meet its obligations to the DOD contract.

My stringent URS documentation and adherence to GAMP, we deliver on-time work, stayed compliant, and minimized risk.

Of course, in that same timeline, orders for several other supporting fill and cap assembly lines and processes were also placed and executed. While professionally exhilarating, let’s hope that we never go through another pandemic.

While faced with limited resources, the filler’s automation vendor and others chose to support our projects versus other larger companies. This was strictly due to our proper project management processes and documentation, as well as the rapport that we had built along the way. While on the surface personal relationships may seem unimportant as part of performing automation project activities, it has the potential to be one of the most important aspects of a successful project, especially when situations are critical.