Automated PQ: The Missing Link in Most Validation Packages

Think Your MES or QMS Vendor Covered Validation? Think Again.

You just rolled out a new MES or QMS and your vendor provided a validation package. It includes IQ, OQ, and maybe even some PQ templates. So you are fully validated, right?

Not quite.

The Truth Behind “Validation Packages”

Most MES and QMS vendors provide a solid start. Their packages often include:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Basic Performance Qualification (PQ) templates

But here is the catch. They do not execute your PQ. That critical final step is still on you.

After software configuration is complete, you are responsible for proving the system performs as required in your environment. That means creating test cases, executing scripts, capturing evidence, and documenting results for auditors.

That is where the real validation workload begins.

Why Automated Validation Tools Still Matter

A tool like SIMCO’s automated validation platform picks up where vendor packages leave off. It helps you:

  • Execute PQ tests quickly and consistently
  • Eliminate manual testing errors
  • Generate audit-ready documentation
  • Launch new systems faster with less resource strain

Without automation, most quality teams are stuck executing PQ manually. That slows down go-live timelines, adds compliance risk, and burns out already overloaded teams.

You Bought the Software. Now Prove It Works.

Your vendor validation package is the blueprint. Automated PQ execution is the buildout. If you stop at IQ and OQ, your validation is incomplete.

To protect your business, your data, and your compliance standing, you need to close the loop with a complete, efficient PQ process.

Ready to simplify your PQ validation?
Discover how SIMCO’s Automated Software Validation Tool can accelerate compliance and eliminate manual testing headaches.

Interested in learning more about how to automate your software validation process?
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