We assist you with your Installation Qualification (IQ) & Operational Qualification (OQ)

Certified IQ/OQ – Documentation and traceability – Quality-assured operation from the start

What is IQ/OQ?

Installation Qualification

Installation Qualification (IQ) verifies that the delivered system has been installed and configured according to the customer’s order.
An IQ from ICU Scandinavia includes:

Verification that all equipment is installed according to the customer’s specifications, for example, that all sensors are mounted in the correct equipment.
Verification that the server/computer meets the requirements for the Boomerang system.
Verification that all software is correctly installed.
Verification that the system is configured according to the customer’s specifications, such as logging, alarms, alarm distribution, backup settings, etc.

Operational Qualification

Operational Qualification (OQ) ensures that the system operates correctly according to the configured setup.
Note: Installation Qualification (IQ) must be approved before OQ can be performed.

An OQ from ICU Scandinavia includes:

Verification that the system’s sensors measure values accurately, e.g., that all sensors are calibrated.
Verification that the alarm system functions correctly.
Verification that alarm distribution works properly.
Verification of traceability.
Verification that reporting and data export function correctly.
Verification that the backup function works.
Verification that the Boomerang application operates as intended.

Is IQ /OQ needed?

To answer that question, it’s important to understand the difference between validation and qualification.

Validation refers to the entire lifecycle of a product or process — from development and use to maintenance — where the company itself is responsible for ensuring that personnel, equipment, methods, and procedures comply with applicable regulations (such as GMP or GLP).

Qualification is a part of validation and focuses on ensuring that systems and modules function as intended before they are put into operation, and continue to do so according to established procedures.

IQ/OQ is especially recommended for:

Production facilities, e.g., pharmaceutical companies and cleanroom environments
Accredited laboratories
Anyone looking to validate and quality-assure their systems and processes

With an Installation and Operational Qualification (IQ/OQ) from ICU Scandinavia, you receive documented proof that your Boomerang system operates correctly and meets high standards — an important step for those who want to ensure quality, performance, and compliance.

Contact us for your IQ/OQ

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