Installation Qualification (IQ) – Proving the System You Installed Is the System You Intended

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Qualification & Validation • See also: IQ/OQ/PQ, CSV, GAMP 5, 21 CFR Part 11, Annex 11, Data Integrity

Installation Qualification (IQ) is the documented demonstration that an asset—equipment, utility, facility system, or computerized system—has been delivered, installed, configured, and connected according to approved specifications and supplier recommendations, in the correct environment, with all required ancillary components present, identified, and controlled. IQ establishes that the “as-installed” state faithfully matches the “as-designed” and “as-specified” state captured in procurement and design records. In regulated manufacturing, IQ is the foundation of the lifecycle that proceeds to Operational Qualification (OQ) and Performance Qualification (PQ), and, for computerized systems, aligns with risk-based Computer System Validation (CSV) per GAMP 5. IQ evidence interfaces with Document Control, Change Control, Asset Calibration Status, and ongoing CPV or maintenance programs to ensure continued qualified state.

“IQ is the moment of truth: if the installation isn’t identical to the design, no amount of testing later can make it compliant.”

1) What It Is

IQ is a structured protocol and report establishing that the received and installed system matches approved requirements: manufacturer, model, serial number, identifiers (GTIN/UDI) where applicable; correct options, firmware/software versions, and licensed features; correct utilities (electrical phases/amps, compressed air quality, gases, water systems), environmental conditions (temperature, humidity, cleanliness), and mechanical anchoring; correct safety devices, guards, interlocks, and HMI access controls; verified wiring and piping against as-built drawings; verified labels, calibration, and cleanroom classifications if relevant. It confirms that required documentation—manuals, drawings, maintenance schedules, certificates (materials, welds, surface finishes), CoA for critical components, FAT/SAT reports—is present and version-controlled. IQ also records the baseline state from which any subsequent changes must be assessed, ensuring traceability for inspections and investigations.

2) Regulatory Anchors & Scope

Qualification and validation practices are embedded across predicate GMPs and GLPs: drugs/biologics (21 CFR 210/211), medical devices (820), laboratories (58), foods (117), and supplements (111). Electronic records/signatures applied to IQ documentation fall under 21 CFR Part 11 (and EU Annex 11). CSV guidance for software-controlled equipment follows GAMP 5’s risk-based framework. IQ is also referenced implicitly in Cleaning Validation and Cross-Contamination Control where facilities and utilities must meet defined standards before process validation.

3) What a Good IQ Contains (Evidence & Traceability)

• Item identity & pedigree: make/model/SN, firmware/software build, options/licensing; supplier docs (FAT, manuals), receiving checks linked to Goods Receipt and Component Release.
• Location & environment: room/zone, cleanliness class, EM requirements (hooks to Environmental Monitoring), storage/ambient constraints.
• Utilities & connections: electrical (voltage/phase/ground), pneumatics, vacuum, gases, steam, water (WFI/PW), network; verification against P&IDs and wiring diagrams.
• Safety & guarding: interlocks, e-stops, guarding presence and function; signage and poka-yoke features installed as specified.
• Documentation set: as-built drawings, BOM, certificates (weld, surface finish, elastomers), vendor IQ checklists, retention/archival plan.
• Calibration & metrology: installed instruments identified and placed into calibration status with references and due dates; initial as-left values.
• Software & access: application versions, configuration baselines, users/roles per Part 11, audit-trail enabled, time sync verified.
• Cleaning & materials compatibility: detergents/agents approved and documented; cleaning validation starting parameters.
• Deviations & concessions: any departures logged as Deviation/NC with risk assessment and impact on OQ/PQ.

4) Process & Governance

IQ follows a plan–execute–report cycle controlled by the quality system. The plan (protocol) defines acceptance criteria for each element (utilities, environment, documentation, safety, software configuration), sampling approaches for verifications, and objective evidence to capture (photos, serial tags, screen captures, calibration stickers). Execution may involve vendor representatives and internal engineering with segregation of duties for independence. Failures are recorded immediately as deviations with disposition, and only after closure can the final report recommend proceeding to OQ. All documents flow through Document Control, and any design or procurement mismatches trigger Change Control. Where electronic records are used, system access, audit trails, and e-signatures must be proven as part of the IQ baseline for CSV/GAMP alignment.

5) Typical IQ Failure Modes & How to Avoid Them

• “Almost the same” hardware/software. Small option or firmware differences later invalidate OQ/PQ. Fix: tie identity to model, SN, and exact firmware/build; use Barcode Validation or configuration exports.
• Utility mismatches. Voltage or air quality out of spec causes intermittent failures. Fix: measure and record utilities during IQ; add monitored alarms if critical.
• Missing documentation. As-builts and manuals not captured. Fix: make document receipt a blocking step; store under Document Control with version IDs.
• Audit trail/time sync disabled. Compromises Data Integrity. Fix: enable/verify audit-trail and NTP time at IQ with evidence.
• Calibration not established. Sensors installed but not enrolled. Fix: register all instruments and set due dates before OQ.
• Unassessed deviations. Minor fit-ups ignored. Fix: log every variance as NC with risk comments feeding OQ test design.

6) Metrics & Maintaining the Qualified State

IQ is a point-in-time milestone, but its value persists if you maintain configuration control. Track cycle time from receipt to IQ approval; first-pass IQ acceptance rate; number and severity of IQ deviations; proportion of assets with verified audit-trail/time sync; percentage of instruments enrolled before OQ; and retrievability time for IQ packets during audits. Link IQ baselines to preventive maintenance and calibration plans; require Change Control for any hardware/software modifications, re-running targeted IQ/OQ as needed to preserve validated status and protect Batch Release decisions downstream.

7) How This Fits with V5

V5 by SG Systems Global provides the governance and execution rails to plan, perform, sign, and retrieve IQ with full traceability. In V5 QMS, IQ protocols are authored and approved under Document Control with Part 11-compliant signatures; execution captures photos, serials, configuration exports, and calibration certificates directly into the record; exceptions open Deviations/NCs with routed approvals; and the final IQ report pins the released configuration for OQ/PQ. In V5 MES, equipment status (“Installed/Qualified”) and calibration state are enforced at runtime so operators cannot start eBMR steps on unqualified assets. In V5 WMS, spare parts and firmware media are controlled as materials with Barcode Validation to avoid wrong-version installs. For connected labeling and data flows, EPCIS events can capture installation and configuration milestones, and audit trails preserve who/what/when/why across modules for inspections.

8) FAQ

Q1. How is IQ different from OQ and PQ?
IQ proves correct installation and documentation; OQ challenges functions against predefined ranges; PQ demonstrates the system performs for intended product/process under normal conditions. See IQ/OQ/PQ.

Q2. Does software require IQ?
Yes—computerized systems require “installation” evidence too: server specs, OS/DB versions, application builds, configurations, security roles, time sync, and enabled audit trails per GAMP 5/Part 11.

Q3. When do we need to re-IQ?
After significant changes to hardware, software, utilities, or environment; following major maintenance; or when deviations indicate the baseline may no longer be valid. Manage via Change Control.

Q4. Can vendor FAT/SAT replace IQ?
FAT/SAT are valuable inputs, but site-specific installation, utilities, roles, and records must still be verified under your quality system. Reference FAT results within your IQ.

Q5. What if as-built drawings are late?
Treat as a deviation and block OQ until received and approved under Document Control. Drawings are part of the IQ acceptance set.

Q6. How do we show data integrity at IQ?
Capture evidence that audit trails are enabled, time is synchronized, and user/role matrices are implemented; sign electronically per Part 11 with reason-for-signature meaning defined.

Q7. Are cleaning and allergen controls part of IQ?
Where relevant, yes—document installed cleaning materials/equipment, approved agents, and segregation controls linked to Cleaning Validation and High-Risk Allergen management.

Related Reading
• Lifecycle & Validation: IQ/OQ/PQ | CSV | GAMP 5
• Records & Integrity: 21 CFR Part 11 | Annex 11 | Audit Trail (GxP) | Data Retention & Archival
• Quality Controls: Document Control | Change Control | Asset Calibration Status | Cleaning Validation
• Operations & Release: eBMR | Finished Goods Release | EPCIS