Installation Qualification & Operational Qualification
For life science and biotech facilities where compliance is non-negotiable, Palico offers an optional comprehensive IQ/OQ service performed by our experienced team
Installation Qualification (IQ)
During the Installation Qualification, we systematically verify that your equipment has been delivered and installed in accordance with the manufacturer’s specifications and your facility’s requirements. This includes confirming correct assembly, utility connections, environmental conditions, and that all necessary components are present and accounted for. Every check is documented in full, providing a clear and auditable record that installation was completed correctly.
Operational Qualification (OQ)
The Operational Qualification phase verifies that the equipment performs as intended across its defined operating range. Our team conducts functional testing against predetermined acceptance criteria, ensuring the instrument behaves consistently and reliably under the conditions it will be used in. Any deviations are recorded, investigated, and resolved/corrected before the qualification is signed off.
Documentation & Records
We conduct our IQOQ using manufacturer-provided templates, ensuring that all documentation aligns with the equipment’s validated design and is readily acceptable to regulatory reviewers. All completed qualification documents are compiled into a formal record package and handed over to you upon completion, ready for your quality management system, audit files, or regulatory submissions. Our processes are conducted in accordance with GMP principles, and we are equally equipped to support qualifications under other applicable frameworks and standards.
Get in Touch
Ready to schedule an IQ/OQ for your equipment, or want to find out more about how Palico can support your qualification requirements? Get in touch with our team today and we will be happy to walk you through the process, answer your questions, and put together a plan that works for your facility and timeline