A Lab Manager’s Guide to IQ/OQ/PQ

Ask five lab managers what validation includes and you’re likely to get five different answers. That’s a problem, not just for compliance but for consistency, throughput, and scientific credibility.

In regulated environments, 'validation' isn’t a buzzword; it’s a framework. A discipline. A safeguard. And it only works when it’s applied with precision, consistency, and documentation that stands up to scrutiny.  

If your lab is treating validation as a one-time task, or worse, leaving it up to individual teams to interpret, you’re exposed. Here’s how to close the gap. 

IQ/OQ/PQ: The Core of Equipment Validation  

Let’s start with the basics. Validation for lab equipment typically includes three distinct phases: 

• Installation Qualification (IQ): Confirms that the equipment is installed correctly and meets manufacturer specifications.  

• Operational Qualification (OQ): Verifies that the equipment operates within defined parameters under controlled conditions.  

• Performance Qualification (PQ): Demonstrates that the equipment performs reliably and consistently in its actual working environment.  

These three phases aren’t optional in a GMP lab. They are foundational. Each phase builds on the last, and missing or incomplete documentation at any stage can unravel your audit trail. 

What Auditors Really Look For

Regulators don’t just want to see that validation was done. They want to see:

• A defined validation protocol and rationale 

• Documented results for all three phases, not just initials on a checklist 

• Acceptance criteria that align with your SOPs 

• Traceable calibration records for any instruments used during testing 

• A revalidation plan tied to equipment changes or failures 

If your validation records are outdated, incomplete, or inconsistent across locations, it signals a deeper breakdown in quality control. And that’s exactly the kind of risk profile that invites more scrutiny.  

Validation Isn’t Just for Cleanrooms

Some labs still treat validation as something that only applies to large-scale bioreactors or sterile manufacturing lines. But if your team is generating data for regulatory submission or using instruments that impact product quality, validation applies. 

Examples of equipment that should be validated or revalidated after a repair, a relocation, or upgrades: 

• Cold storage units, especially those storing reagents or samples for clinical use 

• Biosafety cabinets and fume hoods for airflow testing, HEPA filter integrity 

• Incubators and thermal cyclers for consistent environmental conditions 

• Plate readers, pipettes, and balances, if used in critical measurement workflows 

If any of these are out of specification, even temporarily, you risk invalidating the work done using that equipment.  

The Case for Partnering with a Validation Expert

Labs that try to self-perform validation often cobble together their documentation and rely on internal teams to interpret regulatory requirements. This can create unnecessary exposure in regulated biotech, pharma, and research settings.    

In comparison, a validation partner provides:

• Protocol development customized to your lab and equipment portfolio 

• Standardized execution by certified and accredited technicians 

• Traceable documentation that meets regulatory expectations 

• Support for cleanroom, utility, and method validation, not just instruments 

Flagship Lab Services provides full IQ/OQ/PQ validation performed by Life Sciences Technicians (LSTtm) trained in lab compliance. We also handle revalidation after equipment moves, gets repaired, or your process changes, so that nothing falls through the cracks.  

When should lab equipment be revalidated

This is where we see many labs stumble. While initial validation may be in place, there’s no clear policy on when to revalidate. If your lab’s revalidation policy is lacking, now’s the time to tighten it up. Here’s a suggested framework to help you determine when revalidation is needed: 

The Link Between Validation and Data Integrity

If a plate reader drifts out of range and isn’t caught due to poor validation protocols, you may generate weeks of faulty data. That’s not just a technical issue; that’s a risk to scientific outcomes, reputational trust, and operational continuity.  

Strong validation policies:  

• Confirm equipment is fit for a specific purpose 

• Reduce batch failure rates 

• Protect downstream results 

• Improve auditor confidence 

In short, validation ensures that when your equipment speaks, you can trust what it’s telling you.

Final thought: Validation Shouldn’t be a Mystery 

If your team is asking “Do we really need to validate this?” or if your documentation is spread across filing cabinets and disconnected spreadsheets, it may be time to rethink your approach. 

Validation isn’t just about passing an audit; it’s about protecting your science.