IQ, OQ, PQ: Definitions, Key Activities, Deliverables, and Relationship

IQ, OQ, and PQ are standardized equipment qualification protocols used in regulated industries to confirm that systems, instruments, and equipment are installed correctly, operate as intended, and perform reliably under real-world conditions.

Installation Qualification (IQ) focuses on ensuring the proper delivery, installation, and configuration of equipment. Operational Qualification (OQ) verifies that equipment functions consistently within defined parameters under controlled conditions. Performance Qualification (PQ) demonstrates reproducibility and compliance during routine use.

Together, IQ, OQ, and PQ form a sequential validation framework, with each stage building on the previous one to ensure equipment reliability, regulatory compliance, and product safety. IQ, OQ, and PQ are essential in highly regulated sectors, such as pharmaceuticals, biotechnology, medical devices, life sciences, and food manufacturing, where they safeguard quality and protect patients or end-users.

Quality management software helps streamline IQ, OQ, and PQ processes by standardizing documentation, automating document workflows, and ensuring traceability across qualification activities.

SimplerQMS is a fully validated QMS software designed for life science companies. SimplerQMS supports the management of IQ, OQ, and PQ documentation within your quality system. SimplerQMS software itself is fully validated according to ISPE GAMP5 with completed IQ, OQ, and PQ protocols. This ensures compliance, reduces manual work, and keeps your organization inspection-ready with audit-ready records.

What Is IQ, OQ, PQ?

IQ, OQ, PQ protocols are standardized equipment qualification steps used in regulated industries to confirm that systems, instruments, or equipment are installed correctly, operate as intended, and perform reliably under real-world production conditions.

Grouped together, IQ, OQ, and PQ form the foundation of the equipment qualification process by providing documented evidence of compliance and reliability, ensuring that equipment is suitable for use.

IQ, OQ, and PQ are essential in highly regulated industries such as pharmaceuticals, biotechnology, medical devices, life sciences, and food manufacturing, where they help safeguard product quality, ensure patient safety, and support regulatory compliance.

What Is Installation Qualification (IQ)?

Installation Qualification (IQ) is the documented process of verifying that equipment, instruments, or systems are delivered, installed, and configured in accordance with approved design specifications, manufacturer, and regulatory requirements. The objective of IQ is to ensure that the installation meets predefined criteria before the equipment is put into operational use. IQ provides documented evidence that all installation activities are performed correctly, providing a reliable foundation for subsequent qualification stages.

The most common steps in performing IQ are explained below.

1. Development of IQ Protocol: Create and approve a protocol outlining the scope, objectives, responsibilities, testing procedures, and acceptance criteria for IQ activities. The protocol should align with design specifications, vendor documentation, and applicable regulatory requirements.
2. Verification of Delivery and Components: Ensures that all equipment, components, and accessories are delivered according to purchase orders and design specifications. Validation or engineering teams inspect for damages, missing parts, and conformity with supplier documentation. They also verify that all required documents, such as operational and maintenance manuals and certificates of conformity, are included.
3. Installation According to Specifications: Confirms that equipment is installed per manufacturer requirements, engineering drawings, and internal SOPs. The installation team verifies environmental suitability and utility connections, such as electrical supply, ventilation, or temperature control. A unique equipment identifier or asset tag is applied for traceability.
4. Calibration and Initial Setup: Critical instruments, sensors, or measuring devices are calibrated to confirm accuracy before operational use. Qualified technicians perform these tasks, supported by calibration certificates, in compliance with GMP and ISO standards. A preventive maintenance (PM) schedule and a list of recommended spare parts are established to ensure the continued performance and reliability of the system or equipment.
5. Documentation of Installation Activities: Every installation activity during IQ is recorded in structured protocols, checklists, and logbooks. These records provide traceability and evidence during audits or regulatory inspections.
6. Review and Approval of IQ Results: Quality assurance or engineering managers review the IQ documentation. Final approval is granted through signatures, authorizing progression to OQ testing.

Deliverables from IQ generally consist of the following records.

• IQ Protocol and Checklist: Predefined documents outlining test steps, acceptance criteria, and responsibilities for the qualification process.
• As-Built Drawings and Specifications: Verified design documents and engineering records showing the equipment as installed.
• Calibration Certificates: Documented evidence that critical instruments and measuring devices were calibrated during installation.
• Installation Records and Logs: Detailed documentation of environmental conditions, utility connections, and setup activities.
• Deviation Reports (if applicable): Records of any deviations or nonconformities identified during installation and the corrective actions taken.
• IQ Report with Approvals: A finalized report summarizing results, reviewed and signed by responsible parties to authorize progression to OQ.
• Preventive Maintenance Schedule and Recommended Spare Parts List: Documentation outlining scheduled maintenance activities and spare parts required to support continuous and reliable operation.

What Is Operational Qualification (OQ)?

Operational Qualification (OQ) is the documented process of verifying that equipment, instruments, or systems operate according to predefined specifications and functional requirements under controlled conditions. The objective of OQ is to confirm that the system consistently performs as intended before use in production or real-world environments. OQ provides assurance that equipment functions reliably within its defined operating parameters and safety limits.

Typical steps involved in performing OQ are outlined below.

1. Development of OQ Protocol: Defines the tests, acceptance criteria, and responsibilities for verifying operational performance. QA or validation teams prepare this protocol in alignment with regulatory requirements such as the FDA, GMP, and ISO.
2. Execution of Functional Tests: Tests are carried out to verify that the equipment performs as intended within specified operating ranges, such as temperature, pressure, speed, or capacity. Validation engineers or technical staff perform these tests under controlled conditions.
3. Challenge and Stress Testing: Equipment is subjected to conditions at the upper and lower operating limits to confirm reliable performance. Challenge and stress testing help identify system weaknesses and ensure robustness.
4. Verification of Safety Features: Built-in alarms, interlocks, and fail-safes are tested to confirm that the system protects users, products, and the environment in case of deviations. Validation or engineering teams perform these checks to ensure compliance with safety requirements.
5. Documentation of Test Results: Test outcomes are recorded in structured forms, checklists, or validation protocols. These records provide traceability and support inspection readiness.
6. Review and Approval of OQ Results: QA managers or validation leads review the documented results, and approval is granted through authorized signatures, confirming compliance and readiness for PQ.
7. Verification of Data Integrity, Backup, and Security (if applicable): For computerized or automated systems, verify that user access controls, audit trails, and data backup/recovery functions operate as intended.

The typical deliverables of OQ are outlined below.

• OQ Protocol: Predefined document outlining the scope, testing procedures, acceptance criteria, and responsibilities.
• Functional Test Records: Evidence that the system performs according to specified parameters.
• Challenge Test Reports: Documentation of results under stressed or boundary conditions.
• Deviation Reports (if applicable): Records of any issues or failures observed during testing and corrective actions taken.
• OQ Summary Report with Approvals: Final report summarizing results, reviewed and signed to authorize progression to PQ.

What Is Performance Qualification (PQ)?

Performance Qualification (PQ) is the documented process of verifying that equipment, instruments, or systems consistently perform as intended under routine, real-world operating conditions. The objective of PQ is to demonstrate reproducibility, reliability, and compliance when the equipment is used within the actual production environment. PQ verifies that processes consistently deliver products of acceptable quality under normal operating conditions.

Key actions required to complete PQ are explained below.

1. Preparation of PQ Protocol: A PQ protocol is developed to define test plans, acceptance criteria, sampling methods, and responsibilities. PQ protocol is reviewed and approved by quality assurance and regulatory representatives before execution to ensure compliance and objectivity.
2. Execution of Process Simulations: The equipment is tested under routine operating conditions using representative loads, materials, or products and approved procedures. Operators run multiple production cycles to verify that processes consistently deliver expected outcomes.
3. Integration with Processes and Utilities: PQ ensures the equipment functions correctly when integrated with related systems, materials, and utilities. Cross-functional teams verify seamless compatibility and compliance with regulatory requirements.
4. Verification of Performance Consistency: Key process parameters, such as temperature, pressure, or mixing speed, are monitored across multiple runs. The goal of verification of performance consistency is to confirm that the equipment performs reproducibly and maintains control within predefined limits.
5. Assessment of Product Quality Outputs: Finished products or test batches are inspected, sampled, and tested against defined specifications. Results demonstrate that the system consistently produces products of acceptable quality under real-world conditions.
6. Documentation of Test Results: All PQ activities are documented in structured records, including raw data, monitoring logs, and quality test results. These records provide evidence of consistent performance and are maintained for audit and regulatory review.
7. Review and Approval of PQ Results: Quality assurance and regulatory teams review the PQ documentation, verify compliance with acceptance criteria, and sign off on final approval. This authorization confirms readiness for routine production.

The expected deliverables from PQ should include the following.

• PQ Protocol and Test Plans: Predefined documents outlining test scenarios, acceptance criteria, and responsibilities for the qualification process.
• Execution Records and Logs: Documentation of test results, parameter monitoring, and environmental conditions during PQ runs.
• Reproducibility and Performance Data: Evidence that processes or products consistently meet specifications across multiple consecutive runs.
• Deviation Reports (if applicable): Records of any deviations or nonconformances encountered during PQ and the corrective actions taken.
• PQ Report with Approvals: A finalized report summarizing results, reviewed and signed by quality assurance and responsible stakeholders, authorizing release of equipment for routine use.

What Is the Relationship Between IQ, OQ, and PQ?

The relationship between IQ, OQ, and PQ is that they represent the three sequential stages of equipment qualification, each building on the previous one to complete the validation lifecycle. Together, IQ, OQ, and PQ ensure that equipment is installed correctly, operates as intended, and performs reliably under real-world conditions.

The three core stages of qualification are outlined below.

1. IQ Verifies Installation: Installation qualification confirms that equipment is delivered, installed, and configured according to approved design specifications, manufacturer protocols, and regulatory requirements. IQ provides the foundation for further qualification activities.
2. OQ Verifies Operational Functionality: Operational qualification demonstrates that the equipment consistently operates within predefined limits under controlled conditions. The OQ stage helps ensure that performance specifications are satisfied before transitioning to production environments.
3. PQ Verifies Performance Under Process Conditions: Performance qualification validates that the equipment performs reproducibly and reliably during routine use with actual materials, processes, and utilities. PQ confirms long-term suitability and compliance.

Each stage of IQ, OQ, and PQ is interdependent, producing documented evidence required for the next phase. Skipping or inadequately executing one stage compromises the reliability of the overall validation process. Together, IQ, OQ, and PQ form a sequential compliance framework that is essential for regulated industries.

What Is the Difference Between Qualification and Validation?

The difference between qualification and validation lies in their scope and focus within regulated industries.

Qualification is a documented process that ensures equipment and systems are installed correctly, operate as intended, and perform consistently under real operating conditions. Qualification typically involves the three core stages of IQ, OQ, and PQ, which together confirm that the equipment is suitable for use.

Validation, on the other hand, is the broader activity of proving that an entire process, method, or system consistently produces results that meet predefined quality and compliance requirements. Validation extends beyond equipment to cover manufacturing processes, cleaning methods, analytical procedures, and more.

In practice, qualification supports validation. Without qualification, process validation would lack a reliable foundation.

In simple terms, qualification answers the question, “Is the equipment working correctly?” while validation asks, “Does the process consistently deliver quality results?”

What Are the Regulatory Expectations for IQ, OQ, and PQ?

Regulatory expectations for IQ, OQ, and PQ are defined across global requirements such as FDA 21 CFR Part 211, EU GMP Annex 15, ISO 13485, and ICH Q10. While EU GMP Annex 15 provides the most direct guidance on IQ, OQ, and PQ, other regulations reference these activities indirectly through requirements for validated processes, qualified equipment, and calibrated instruments to monitor those processes. Each qualification stage includes specific requirements to ensure that equipment and systems are properly qualified and validated for compliant use in regulated industries.

• Installation Qualification (IQ): Regulatory frameworks require documented evidence that equipment is installed in accordance with approved design specifications and manufacturer requirements. For example, EU GMP Annex 15 (Section 3.8 and 3.9) specifies that IQ must verify installation, documentation, calibration, and supporting utilities. Similarly, ISO 13485 provides guidelines in relation to infrastructure and equipment management.
• Operational Qualification (OQ): FDA 21 CFR Part 211.68 and EU GMP Annex 15 (Section 3.10-3.12) mandate testing of equipment functions to confirm that systems operate within predefined ranges. OQ ensures alarms, controls, and operating parameters meet safety and performance requirements under controlled conditions.
• Performance Qualification (PQ): FDA process validation guidance and EU GMP Annex 15 (Section 3.13-3.14) require PQ to demonstrate consistent performance in real-world production. PQ must show that processes produce reproducible results that meet product quality and compliance standards across multiple runs.

Together, IQ, OQ, and PQ provide the documented assurance that regulators expect for equipment qualification. IQ, OQ, and PQ form a lifecycle approach to validation, ensuring compliance, patient safety, and product quality.

What Are the Common Challenges Across IQ, OQ, and PQ?

The common challenges across IQ, OQ, and PQ are outlined below.

• Documentation Gaps: Missing or incomplete protocols, checklists, or reports weaken traceability and make it difficult to demonstrate compliance during audits.
• Resource Constraints: Limited availability of skilled personnel, time, or budget often slows down qualification and increases the risk of errors.
• Protocol Deviations: Failure to follow approved qualification protocols can invalidate results, requiring costly retesting and rework.
• Regulatory Non-Compliance Risks: Inadequate alignment with FDA, GMP, or ISO requirements exposes organizations to inspection findings, warnings, or penalties.
• Change Management Issues: Uncontrolled changes to equipment, processes, or documentation can disrupt qualification consistency and traceability.
• Technology and System Challenges: Legacy systems, lack of automation, or integration problems complicate qualification execution, monitoring, and reporting.
• Training and Competency Gaps: Insufficient training or lack of experience leads to errors and inconsistencies in executing qualification protocols.
• Vendor and Supplier Dependence: Delays in receiving documentation, calibration certificates, or technical support from external vendors can stall the qualification process.
• Complex Equipment and Processes: Highly specialized or integrated systems increase the difficulty of writing, executing, and maintaining qualification protocols.
• Cost Overruns: Extended timelines, repeated testing, and unexpected protocol deviations can drive qualification costs beyond the allocated budget.

What Are the Best Practices for IQ, OQ, and PQ?

The best practices for IQ, OQ, and PQ are outlined below.

• Robust Documentation: Maintain complete and accurate documentation for each qualification stage to ensure traceability, audit readiness, and regulatory compliance.
• Clear Acceptance Criteria: Define measurable and unambiguous acceptance limits before testing begins, reducing ambiguity and preventing disputes during reviews.
• Cross-Functional Collaboration: Engage engineering, quality, regulatory, and operations teams to ensure that all perspectives are considered and risks are addressed.
• Regulatory Alignment: Align qualification protocols with FDA 21 CFR Part 11, EU GMP Annex 15, ISO 13485, ICH Q10, or other relevant industry requirements to avoid compliance risks and inspection findings.
• Risk-Based Approach: Prioritize qualification activities based on the criticality of equipment and processes, focusing resources where potential failures would have the highest impact on quality and patient safety.
• Change and Lifecycle Management: Implement structured processes to control changes or updates, requalification, and continuous monitoring throughout the equipment lifecycle.
• Training and Competency Development: Ensure personnel involved in qualification are properly trained and competent, reducing execution errors and ensuring consistency.
• Use of Standardized Protocols and Templates: Apply standardized qualification documents and templates to improve efficiency, consistency, and audit readiness.
• Leverage Automation and Digital Tools: Utilize eQMS or validation software to manage protocols, approvals, audit trails, and evidence, minimizing manual errors.
• Periodic Review and Requalification: Conduct periodic reviews of equipment performance and requalify as necessary to maintain compliance throughout its lifecycle.
• Vendor and Supplier Involvement: Engage suppliers early to provide calibration certificates, technical documentation, and support during qualification activities.

How Does SimplerQMS Streamline IQ, OQ, and PQ Processes?

SimplerQMS streamlines IQ, OQ, and PQ or QMS software validation processes by automating workflows, integrating document control, and embedding regulatory compliance requirements. This QMS software validation ensures consistent execution of qualification processes, reduces manual effort, and helps organizations maintain a continual state of audit readiness.

SimplerQMS is a fully validated life science eQMS designed specifically for life science companies. As a digital QMS, it simplifies qualification processes by centralizing records, automating approval workflows, and supporting compliance with regulatory requirements. The system helps manage documentation and maintain audit readiness across IQ, OQ, and PQ by providing secure audit trails and version control.

Key features that address common qualification challenges are outlined below.

• Automated Documentation Management: Centralizes qualification records, maintains version control, and ensures traceability for audits and inspections.
• Regulatory Compliance Support: Helps manage qualification documentation in accordance with FDA 21 CFR Part 11, EU GMP Annex 15, ISO 13485, and other requirements.
• Workflow Automation: Routes qualification documents through structured approval workflows, reducing manual errors and ensuring timely execution.
• Risk and Change Management: Provides tools to assess risks, manage deviations, and control equipment or process changes throughout the lifecycle.
• Audit Readiness: Supports data integrity, maintains secure audit trails, and provides clear, traceable documentation for regulatory inspections and audits.

By automating workflows, supporting compliance, and centralizing documentation, SimplerQMS helps organizations save time, reduce errors, and remain inspection-ready.

SimplerQMS is fully validated in accordance with ISPE GAMP5 guidelines, ensuring a compliant and structured approach to software validation. The system’s own IQ, OQ, and PQ are already completed by SimplerQMS, so customers do not need to perform separate system validation.

In addition to qualifications, SimplerQMS supports a broad range of QMS processes, including document control, training, CAPA, audits, change control, design control, supplier management, equipment management, and more. This comprehensive functionality helps life science companies ensure compliance with GMP, FDA 21 CFR Part 11, EU GMP Annex 15, ISO 13485, ICH Q10, and other regulatory requirements, while improving efficiency and business continuity.