Using Software in Process Validation

Using Software in Process Validation

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.

Oct 01, 2019

By Robert Glaser

BioPharm International

Volume 32, Issue 10, pg 22–25

JohanSwanepoel - Stock.Adobe.comWithin pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straightforward, but how does one achieve this when it involves a myriad of multiple systems (programmable logic controllers [PLCs], human-machine interfaces [HMIs], control systems, etc.) and requires a team effort that encompasses people from various disciplines within the plant?

It is important to design processes that ensure product quality, safety, and efficacy. Today’s software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right way. For instance, these systems can deliver clear documentation, provide version control for the multitude of systems in use, and perform backup to ensure all risks are mitigated...

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