Simplify Your GMP Validation with Code Modules

Simplifying Acceptance Testing starts with design docs and software developed with a solid foundation of GMP change control. There are many ways to write process control code, but leveraging certain tools like code modules and parameter UDTs can greatly reduce both the initial validation effort and future system modifications.

Ask us how we can help manage the validation effort for your next automation control project.One biopharma project I was on saved over 300 pages of testing by replacing the traditional PLC & HMI structure with a set of AOI’s in about 8 lines of a structured text ‘FOR’ loop. This let us heavily leverage parameter files for indirect HMI display addressing. Combining these techniques, we had fewer custom links to validate leading to a reduced Data Display, Data Entry, Alarming, and Security testing required.

While I cherry-picked this example from my experience in a highly regulated industry, it highlights the possible effectiveness and savings that may be achieved by selecting the right tool. All projects are unique and this is just one of many efficiency techniques in your toolbox.

However, if engage the Validation/Quality groups early in a project, you have more opportunity to find a clever solution early and make everyone’s job easier.