Evolutions In Pharmaceutical Validation

By Andrey Yermakovich

Since the 70’s, the industry has gone through a major change with many regulations, standards, and guidelines that govern CQV (Commissioning, Qualification and Validation) practices being put in place. Then more recently it now has to be demonstrated that all risks are mitigated, machines and processes are fit for intended use, and software and all functions operate as designed in a predictable and repeatable manner.

Today machines come integrated with complicated software packages. Industry demands sophisticated vision, servo, SCADA, and track & trace solutions. Isolators, barrier systems, and complex fill-finish systems are changing the landscape in the industry. There is a lot of buzz about “big data,” “connectivity,” “industry 4.0,” “smart machines,” and some of these concepts are already a new reality. It’s no longer about conveyors and vial handling systems.

In this article we will discuss how the industry changed and how we can help you adapt to the new business environment.