Prove it was installed the way it was designed.
Environment baseline, installation script verification, configuration capture and IQ execution — with evidence auto-linked to the RTM.
Installation Qualification confirms a system was installed as designed: the correct software version and build, the approved configuration, qualified infrastructure, working interfaces and the specified security roles. It is short, factual and almost entirely about capturing evidence rather than exercising the system, and it must be reported before Operational Qualification begins.
Outcomes you can expect
- Executed IQ protocol + evidence
- Configuration baseline record
- RTM-linked evidence
Installation Qualification (IQ) Services is delivered by our validation & compliance services practice. Where it saves time, the team uses our products: GxP Copilot for validation lifecycle work and TraceDraft for clinical documentation.
Explore related capabilities: Computer System Validation (CSV), Computer Software Assurance (CSA), AI Validation Services (Annex 22), FDA 21 CFR Part 11 Compliance.
What Installation Qualification Must Document
Installation Qualification is the formal first phase of the GxP lifecycle qualification sequence. Its purpose is precise: confirm that a system was delivered and installed in accordance with the approved specification, and capture the configuration baseline at the moment of installation. IQ is not a test of whether the system works — that comes in OQ. IQ establishes the reference point that every future change control event compares against. If the baseline is wrong or incomplete, the entire downstream qualification history is unreliable.
A compliant IQ documents: hardware and software components delivered match the purchase order and vendor spec; the installation environment meets vendor requirements for power, temperature, network, and space; the software version installed matches the Validation Plan; physical installation details such as cable labeling, earthing, and rack mounting are verified; and the initial configuration baseline is captured and placed under version control. Our IQ protocols are adapted to each system type — cloud SaaS tenancy configuration, on-premise LIMS installation, laboratory instrument firmware baseline — not applied from a generic template.
Evidence Standards That Survive Inspection
IQ evidence must meet three standards: contemporaneous (recorded at the time of installation, not reconstructed), attributable (signed and dated by the person who performed the check), and complete (every protocol step has a recorded result). Screenshots as IQ evidence are valid only when they are unambiguous, carry a system date/time stamp, and are stored in a controlled location preventing post-execution editing.
For cloud SaaS systems, the IQ scope shifts from physical installation to configuration baseline documentation: tenancy settings, security configuration, integration endpoints, and data centre location. For laboratory instruments with embedded software, IQ captures model, serial number, firmware version, calibration status, and environmental monitoring of the installation location. We manage IQ evidence to these standards across every engagement, producing a record that can be reconstructed coherently by an independent reviewer years after installation.
See it on your own system.
Bring a URS or a system. We show you the validation package it produces.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan and scope