Scott in design sent me this article published just late last year. Entitled “Critical components of FDA-Regulated Pharmaceutical Labeling,” it features an interview with Ardi Batmanghelidj who has worked extensively in FDA-regulated environments for over 25 years and is currently president of a software development and IT consulting firm specializing in solutions and services for the pharmaceutical industry.
If you work in life sciences/pharma IT, you don’t need to read this piece . . . you live it. But if I were you, I’d print it out and somehow get copies of it into the hands of every C-level executive in your company. Few articles I’ve read so clearly explain how and why FDA-regulated products have special labeling needs. For example, Mr. Batmanghelidj in classic understatement very simply says:
Whereas most industries assign labeling to the purview of IT and/or packaging personnel, pharma companies must also involve manufacturing, quality assurance, quality control, regulatory affairs, legal and even marketing in their labeling systems and standard operating procedures (SOPs). As any operations manager will tell you, the goals and objectives of different departments in a corporation rarely align perfectly. Consequently, the process of merely coordinating the human resources to effectively manage regulated labeling is a challenge.
Meanwhile, in terms of his advice to life sciences/pharma companies seeking a labeling solution, I not only concur with his advice completely, but also wish to say it sounds like he could have been doing this interview on our behalf. He wasn’t, I’m sure . . . but it is good to know there are experienced, knowledgeable people who share our point of view.