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In The News

Understanding the Differences between Validation and Commissioning

Recently featured in the Engineering Angles column of Pharma Manufacturing magazine, read the complete article here or below for a summary of the key points.

Click here to read the Pharma Manufacturing article in its entirety.

Why This Matters

In pharmaceutical, biotech, and medical device manufacturing, the terms commissioning and validation are often misunderstood or used interchangeably. However, the differences are critical—especially when it comes to compliance, product quality, and regulatory approval.

What is Commissioning?

Commissioning prepares systems and equipment for operation but doesn’t ensure compliance. Learn what it includes and how it fits into project delivery.

Commissioning focuses on ensuring that all facilities, utilities, and equipment are installed and functioning as intended. It includes:

  • Installation and utilities verification

  • Functional testing (e.g., FAT and SAT)

  • Calibration and operational readiness

  • Troubleshooting and performance checks

This process verifies that a system is “as-built” and operational—but not necessarily compliant with regulatory expectations.

What is Validation?

Validation proves that a system consistently meets quality standards and regulatory expectations. Learn the phases and why it matters.

Validation is a documented, regulated process that proves with a high degree of assurance that systems, equipment, or processes consistently deliver results within defined specifications. It is essential for:

  • FDA, EMA, and global regulatory compliance

  • Data integrity (e.g., 21 CFR Part 11, ISO 17025)

  • Quality control and risk reduction

Three core phases of validation:

  • IQ (Installation Qualification) – Verifies correct installation

  • OQ (Operational Qualification) – Tests operational performance

  • PQ (Performance Qualification) – Demonstrates real-world reliability

Common Pitfalls to Avoid

 Learn the top mistakes engineers and QA teams make during validation—and how to prevent them.

Key mistakes include:

  • Treating commissioning as validation

  • Using outdated or generic protocols

  • Failing to train or qualify staff

  • Ignoring traceability to URS/FDS

  • Overlooking minor deviations or typos in documentation

These can lead to compliance issues, rework, or regulatory citations.

Best Practices for Success

Avoid confusion and compliance risk with these tips for aligning commissioning and validation strategies.

To ensure a smooth transition from commissioning to validation:

  • Define the handoff early in the project lifecycle

  • Involve QA and validation teams early in planning

  • Conduct mock qualifications to catch gaps before they matter

Know the Difference—It Matters

Commissioning gets systems ready. Validation ensures they’re compliant and capable of producing quality results.

Misunderstanding the difference can delay projects, increase risk, and lead to regulatory consequences.

Written by Eric Bankos, Senior CQV Engineer

About Genesis AEC

Genesis AEC – an award-winning consulting, architecture, engineering, and construction management firm – has partnered with life sciences companies for more than 25 years to complement the scientific expertise of our clients as they usher in the next generation of life-saving therapies, treatments, and technologies. Whether it’s providing AE support for existing sites; commissioning, validation, and qualification (CQV) for specific processes or equipment; or turnkey design-build solutions, our team blends sound science and technical expertise with quality assurance and safety measures to deliver unparalleled results.