How do we keep up with a speeding car that’s only getting faster? QA and Compliance Specialist Nicola Brady gives an outsider’s perspective on trying to adapt to the ever-changing technologies and tools at our disposal in the life sciences sector.
I’m not naturally tech savvy. I’ll be the first to admit that I call the IT help desk whenever I encounter any issue with my computer – after I try to turn it off and on again, of course – so you’d hardly believe that I studied some computer science elements as part of my undergraduate degree in science. I cast my mind back now to those classes on C+ programming, SQL and database design, biomedical imaging and emerging technologies, and I remember thinking “how is this science?”. Now, the question is “how wrong was I?”
Science and information technology do not exist independently of each other. Look at the life science industry, for example; how would drug product development or drug product manufacturing be possible without the symbiosis of science and information technology? In fact, life science companies these days are investing more time, resources and effort than ever before in implementing and maintaining Information technologies to deliver safe, efficacious and affordable products to patients. The information technologies and tools that I encountered during my studies may even be redundant now (I am not going to share how long ago that was!), as those technologies and tools are evolving so quickly that it is often difficult for organisations to keep pace. Should I have paid more attention? Perhaps, although I could argue that I know what I know, and I certainly know what I don’t know!
Over the course of my career in various Quality Control, Quality Assurance and Compliance roles in the life sciences sector, I have interacted as an end user with my fair share of information technologies and tools. I have supported validation and qualification activities, facilitated risk assessments, conducted investigations and audited the associated processes for these same technologies and tools. But these roles did not require me to be a software developer, or a programmer, or a system builder. There are many more skilled people suitable for performing these types of technical tasks. No, my role is about looking at these information technologies and tools relative to their intended use and application, asking the tough questions like, for example, how will we meet the regulatory requirements? How can we qualify or validate the technology for its intended use? How can we assure data integrity? What do we need to implement to monitor and control?
So, while I will try my best to embrace the new information technologies and tools as they emerge – tools including cloud computing, data analytics, blockchain, IOT (Internet of Things) devices and even AI (Artificial Intelligence) – I will most definitely stay on top of the changing regulatory landscape pertaining to their use in the life science industry.