Director of Information Systems and Data Compliance
It was literally by Chance that IRISYS benefited from Adolfo Ramirez’s talent 6 years ago. Chance Willkomm, Senior Accountant in the finance department, had a broken laptop and sought out Adolfo’s assistance to do the repairs because at the time IRISYS did not have an internal IT department. Though it may have been luck that initially brought Adolfo and IRISYS together, IRISYS is adept at spotting the best talent, and shortly after the first encounter, Adolfo was invited to join the IRISYS team as an independent consultant, and then as an employee. Much like today, IRISYS was growing rapidly, and a new IT department had to be created. Adolfo became the first member of that IT department that has continued to grow with the ever-expanding needs at IRISYS.
Since joining IRISYS, Adolfo’s knowledge and expertise has grown with the company. The bigger the company became, the more advanced the systems became, including in the highly specialized field of computer systems validation for the pharmaceutical industry. Adolfo began his career with a B.A. in Computer Engineering from Autonomous University in Baja California, but because of the increasing regulatory demands in the pharmaceutical industry, he’s now an expert in FDA regulated GxP systems, computer systems validation per 21CFR Part 11 requirements and GAMP5 guidelines, pharmaceutical serialization, and eCTD IND applications. He manages all IT audits conducted by the NIH, FDA, DEA and private clients, and has expertise dealing with laboratory systems and applications, including Agilent, AB Sciex, Cape Cod, Shimadzu, and Thermo Scientific. He also maintains the Electronic Quality Management System, IT Security Training and the Siemens Building Management System for the company. In the pharmaceutical industry, even the computer systems used to produce the data need to be regulated, and Adolfo makes sure that IRISYS is consistently in compliance with the industry guidelines.
Today, the IT field is saturated with talent, but there are few people with Adolfo’s specialized expertise. Though it was a challenge to adapt to the specifications of the industry, Adolfo does not truly see it in that light. His mindset, when it comes to overcoming challenges, is as impressive as his skill set. When questioned about the challenges that he has had to overcome, he couldn’t think of any one that proved insurmountable. “There have been challenges, but I’ve worked hard to overcome them, and they aren’t challenges anymore. You keep working until you can do it.” He embodies a true growth mindset attributing part of his success to the fact that he joined IRISYS when it only had 15 employees and has since been able to grow and learn with the company. And yet, his eyes are still on the horizon in this field.
Three to four years ago, the FDA began reviewing IT systems compliance and computer systems validation for the pharmaceutical industry. Most regulations had been in place since 1997, but they were not widely enforced largely because auditors were from a different era, an era where computers were not widely involved in every aspect of the industry. However, due to the increasing knowledge base of the auditors, the FDA has started enforcing the rules that were already in place. Currently, pharmaceutical companies around the world follow guidelines set forth by GAMP5, or Good Automated Manufacturing Practice, developed by the ISPE, the International Society for Pharmaceutical Engineering.
In the future, Adolfo would like to be part of the development of new ways of approaching computer validation. “The ways that we’re doing it right now have been in place for nearly a decade and the technology is advancing much faster than the guidelines. It’s due for a big overhaul. Take the cloud for example. It is nothing new, but the current regulations don’t cover all of it. There are a couple of addendums, but really the guidelines are written for servers that you have physical access to. I want to help develop a method to meet compliance in a faster and more efficient way, one that is more tolerant of changes because systems are not static, they are changing rapidly.”
Though Adolfo never considered a career in any other field, he also believes that you should not make your job your hobby. In his time away from IRISYS, Adolfo transforms into an adrenaline seeking race car driver! He’s been racing for 14 years, since he was 18, and specializes in “drifting” competitions. He builds the cars as well and helps the Jeff Jones Racing Team, a pro drift team, in their pit during races. There are eight events per year all over the United States. From building the cars to the complexity of the competition, he knows every aspect, and his goal is to obtain a professional drifting license. He estimates that it’s a 3-year project that he’ll start when the time is right, but for now he’s enjoying spending time with his 18-month-old son.