What makes for a great Validation Lead?

What makes a Validation Lead great? Well, my career in software validation started with an SAP implementation at a small generic drug company. My manager used to say: “IT and the business are going to move forward with or without us. Our job is to run along their sides, shore up their work and not get in the way.” I’ve thought over the years about that and why validation often gets a bad rap. If validation can’t learn to be adaptable, open-minded, and creative, it will always be seen as a necessary evil and a roadblock.

As my career advanced, I was able to recruit and manage numerous contract validation leads. What I found was that most staff augmentation organizations are great at providing armies of what I have dubbed the “cut and paste validation leads.” They are proficient at using company-provided documents from previous validations and pasting in the new system names and changing a few details. What they are not good at is critical thinking, suggesting improvements and adding value to the organizations they serve. If you have contracted validation leads in the past, this likely sounds all too familiar to you.

So what makes a Validation Lead a great Validation Lead. First, I believe they need to think beyond the SOP. An SOP should be the framework under which the validation is organized, but now SOP can define every individual consideration in a validation. A great VL can provide creative options when confronted with questions and challenges. A great VL can suggest improvement and a great VL needs to leave things better than they found it. A great Val Lead can work independently with minimal disruption to the clients they serve and a great Val Lead cares about the quality of their work. The bottom line is a great Val Lead adds value and an average Val Lead merely pushes paper forward.

If you need a warm body for a validation project, call the other guy, but if you need proficient, trained, critical-thinking resources, contact us. Compliance Group carefully vets our resources. New employees are placed with veteran employees to shadow and learn from them. We routinely train our resources on Computer Software Assurance (CSA), Data Integrity, MS Word skills, trends in validation, and regulatory enforcement activities.

If you’d like to discuss this subject further, if you need a great Val Lead, or any other needs, call us for an appointment (847.327.3167 x406). As always, we’re here to help.