Why Is Pharma Resistant To Digitization?

By James Irons, Director of Strategic Development, and Samir Patel, Project Lead - Digital Systems, Sequence

A general resistance to digitization is one of the preeminent examples of the pharma industries' struggle to adapt and change with the times. Pharma loves to rely on paper as a single source of truth for record keeping. It’s physical, you can touch it, and that physicality seemingly assures less risk when in fact, this reliance on paper is highly inefficient and can create more risk in the long run. In addition, the inability to properly assess risk can also lead to resistance of implementation of digital solutions across the entire manufacturing process.

Why is it that we’ve grown accustomed to technological advances in our personal lives, but the pharmaceutical manufacturing industry continues to accept practices that haven’t been improved upon in years? Digitizing what basically amounts to a ruled notebook into an electronic solution sounds like an easy win. It’s when you start to dig deeper that this task can quickly become burdensome, especially when presenting the proposed process map and data workflow to a steering committee.

Depending on intended use, this process map may detail the complexities of IT infrastructure/security, hardware (tablets/laptops), managing hardware in clean spaces, electronic signatures, data management, batch process integration and reporting. When the process is fully mapped out with associated costs, the competitor that is the mighty duo of paper and pen may initially come off as the champion in the fight. This is especially true at sites that have been in operation for many years, but a paradigm shift must occur to help move toward adoption of Pharma 4.0.