A Step-By-Step Approach To Digitalizing Biopharma Manufacturing: Part II

By Shawn Opatka, Vice President & GM Life Sciences at Honeywell

Digitalization can be daunting, especially in biopharma industries where compliance and operational workflows are vital. For this reason, many organizations opt for a simpler starting point, concentrating on implementing solutions that can seamlessly mesh with one another and existing systems such as Enterprise Resource Planning (ERP).

While there are a number of ways to embrace early adoption, the most successful involve a modular approach centered on stand-alone digital solutions tailored to the specific needs of the manufacturing operation. These solutions should align with an organization's available resources, budget constraints, and manageable deployment timelines.

A modular approach may include the development of electronic logbooks and procedural guides, weigh and dispense processes, and Master Batch Records (MBR)/Electronic Batch Records (EBR). While the sequence and configuration of these elements can vary based on a company's key priorities and needs, there is a logical progression that can facilitate smoother equipment integration.