- Validation
Installation & Operational Qualification Services
Validation services that protect quality, safety and compliance.
Installation Qualification (IQ) and Operational Qualification (OQ) services validate proper installation and consistent performance of your equipment in regulated industries.
cGMP
IQ + OQ
Audit
Full-range
OVERVIEW
Why customers pick BDH
for IQ/OQ services.
In regulated industries such as pharmaceuticals, biotechnology, healthcare, and manufacturing, ensuring the proper installation and performance of equipment is critical for maintaining quality, safety, and regulatory compliance. “Installation Qualification (IQ)” and “Operational Qualification (OQ)” services are integral components of validation processes that validate the successful installation and proper functioning of equipment, machinery, and systems. These services play a vital role in upholding product
quality, operational integrity, and compliance with industry regulations.
Quick Summary
Installation Qualification (IQ)
IQ is the first step in the qualification process, ensuring that equipment is properly installed according to manufacturer specifications and regulatory requirements. Key aspects of IQ include
Verification of Installation
Technicians verify that the equipment is correctly installed in its designated location, and components are properly connected.
Documentation Review
The documentation provided by the equipment manufacturer is reviewed to confirm that it aligns with the installation process.
Calibration and Verification
Any necessary calibration or verification checks are performed to confirm that the equipment operates within specified parameters.
Functional Checks
Basic functional tests are conducted to ensure that the equipment operates as intended and can proceed to the next qualification phase.
Quick Summary
Operational Qualification (OQ)
OQ builds upon IQ by testing the equipment’s performance under various operational conditions. This phase ensures that the equipment consistently performs within predefined specifications. Key aspects of OQ include
Performance Testing
Equipment is tested under various operating conditions to verify its performance and functionality.
Limit Testing
Equipment is tested at the upper and lower limits of its operating parameters to ensure it performs as expected across its entire range.
Worst-Case Scenarios
Testing is conducted in worst-case scenarios to assess how the equipment handles challenging conditions.
Data Integrity
Data recording and documentation are scrutinized to ensure accurate and comprehensive data collection.
WHAT’S INCLUDED
Benefits of IQ and OQ Services
Quality Assurance
IQ and OQ services ensure that equipment is properly installed, functions as intended, and complies with regulatory requirements.
Risk Mitigation
Verification through IQ and OQ minimizes the risk of equipment failures that could impact product quality, safety, or business operations.
Regulatory Compliance
IQ and OQ services align with regulatory standards, such as FDA's Current Good Manufacturing Practice (cGMP) regulations.
Data Integrity
Rigorous documentation of IQ and OQ processes ensures traceability and supports compliance audits.
Operational Efficiency
Properly validated equipment is more likely to function efficiently, reducing downtime and operational disruptions.
Process Improvement
Identifying potential issues during qualification allows for addressing and improving equipment performance early in its lifecycle.
Conclusion
In conclusion, Installation Qualification (IQ) and Operational Qualification (OQ) services are essential components of equipment validation processes in regulated industries. By ensuring proper installation and functional performance, these services contribute to maintaining product quality, operational excellence, and compliance with industry regulations. Whether you’re launching a new facility or updating existing equipment, IQ and OQ services provide the foundation for a robust and compliant operation.
WHAT’S INCLUDED
A complete service capability
Installation Verification
Confirm correct placement and connection of all components.
Documentation Review
Manufacturer documentation reviewed against installation reality.
Calibration Checks
Calibration checks confirm operation within specified parameters.
Performance Testing
Verify performance and functionality across operating conditions.
Limit Testing
Test upper and lower operating limits for full-range assurance.
Data Integrity
Scrutinize data recording and documentation for accuracy.
HOW WE DELIVER
Our four-step delivery process
Protocol
Approve IQ and OQ protocols tailored to your equipment.
IQ Execution
Verify installation, services and documentation.
OQ Execution
Run performance, limit and worst-case scenario tests.
Certification
Final report, deviation log and signed certificates.
DELIVERABLES
What you receive
- Approved IQ and OQ protocols
- Executed test scripts with raw data
- Deviation and CAPA log
- Final qualification report
- Signed IQ and OQ certificates
GET STARTED
QUESTIONS
Frequently asked
Do you also provide PQ?
Yes, performance qualification (PQ) is available as an add-on with method-specific test scripts.
Can you re-qualify after relocation?
Yes — full re-qualification is available after lab moves or major service events.
Are protocols audit-ready?
Yes. Protocols and reports are formatted for cGMP / regulatory audit consumption.
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Ready to move forward with IQ / OQ
Services?
Our specialists are ready to scope, quote and deliver — typically within one business day.