VALIDATION OF A REGULATED COMPUTER SYSTEM – WHAT’S THE BIG DEAL?

Anyone who has been part of a successful validation effort for a regulated computer system (IT system) should consider themselves lucky souls. Throughout my own personal development, this was likely the most impactful experience that shaped my career development.  There is a lot of activity happening behind the scenes that many may not be aware of unless you too are one of the lucky ones.

Having been on teams validating and deploying IT systems in both regulated and non-regulated industries, I can say with conviction that validating an IT system in a regulated industry can require double or sometimes triple the time and resources.  Before any skeptics take over, allow me to elaborate.

Why Validation of a Regulated Computer System is Important

Many of us have used over the counter (OTC) medicines (e.g. Ibuprofen) or know someone who has.  Likewise, many of us know someone that relies on the accuracy of a medical devicesuch as an insulin monitor or a blood pressure reader.  How does this relate to what I’m sharing about validating IT systems?

To begin with, companies delivering consumable lifesaving products must demonstrate they follow good manufacturing practices (GMPs) including any regulations applicable to the given product.  They must demonstrate their product is safe and efficacious with efficiency and agility to remain competitive and be first to market.

In our modern world, many companies have digitized their processes and utilize IT systems to implement, track and/or monitor the required GMPs.  These systems are a major contributing factor to the company’s confidence level for claims of the safe and efficacious product.  Therefore, validation of IT systems is definitely a big deal.

Especially when these regulated computer systems are used to drive decisions and processes that ensure GMPs and any applicable regulations are effectively implemented.

Why the fuss about the behind the scenes activity? 

From experience, I can assure you they are all important.  Anyone who can consider themselves lucky will tell you that a good methodology and process will return substantial gains of time and quality.  I consider myself lucky because I learned a lot.  I was fortunate to have knowledgeable leaders that took the time to explain the value behind validation.

Great mentors that helped me to appreciate why we were taking the time to draft a good requirement that was not only testable but traceable to what the user needed the system to do.  Like many in the growth phase, I didn’t realize my state of luck at the time.

It wasn’t until I had an opportunity to experience how the impact of budget cuts meant streamlining what validation critics referred to as “overhead.”  We were left with a validation project without the benefits of any planning.  Even the trace matrix was tossed out the window.

I remember these projects all too well because I would lie awake reflecting on what caused the delayed implementation or the countless rework of design.  It always came back to a lack of traceability and planning.

Prepare for the Unexpected (or the Expected)

The reality is that many people have been in or will find themselves in the same budgetary situation.  Budget season is always prime time to make cuts or pull timelines up.  Teams have opportunity to pull in outside experts, but there’s almost always a system learning curve that negates the benefits of onboarding them.

Many software vendors offer validation services.  If your validation standards are like mine, you’ll want to know if they have earned their lucky badge or if they consider themselves lucky at all.  If they look at you as if you were a three-headed monster, that might be a good indication that you should keep looking.

Like shoes, be sure to try on a few.  Walk in them a bit and ensure your validation expertshave done so themselves.  Considering your regulated computer systems to be a critical puzzle piece to the ensuring quality product development; don’t take it lightly.  It’s a big deal.

In Summary

Validation of a regulated computer system is a critical component of a company’s overall Quality Management System and product lifecycle.  It’s an expectation of all global regulator. to drive higher levels of quality and control.  Be selective.

At AssurX, we pride ourselves in ensuring our team has walked in your shoes. Our Validation Management Experts have been around the block and have earned their lucky badges.  If you’re looking for assistance for your computer system validation, contact us today to learn more about the experience that makes us lucky ones.