STATE OF CONTROL | IQ • OQ • PQ
Equipment Qualification &
Validation
We support organizations in qualifying and maintaining equipment in a state of control through structured IQ, OQ, and PQ activities. Our risk-based approach ensures equipment is fit for intended use, compliant with EU GMP Annex 15, ISPE guidelines, and ICH Q9, and ready for regulatory inspections.
Our Equipment Qualification &
Validation Services
Qualification Readiness & Gap Assessment
Proactive evaluation of qualification readiness to identify GMP and compliance gaps prior to regulatory inspections.
Key Deliverables
- Qualification Readiness Assessment
- GMP Compliance Gap Analysis
- Inspection Readiness Summary
Installation Qualification (IQ)
Verification that equipment is installed correctly and complies with approved specifications and utilities.
Key Deliverables
- IQ Protocol & Execution Record
- Installation & Utility Verification
- Installation Deviation Log
Operational Qualification (OQ)
Confirmation that equipment operates consistently within defined limits and functional requirements.
Key Deliverables
- OQ Protocol & Test Scripts
- Operating Range Verification
- OQ Summary Report
Performance
Qualification (PQ)
Demonstration of consistent and repeatable equipment performance under routine operating conditions.
Key Deliverables
- PQ Protocol & Sampling Plan
- Performance Data Review
- PQ Approval Summary
Deviation & Remediation Management
Structured evaluation and resolution of qualification deviations using a risk-based approach.
Key Deliverables
- Deviation Impact Assessment
- Root Cause Analysis (RCA)
- Corrective Action Records
Ongoing Compliance & Requalification
Maintenance of equipment in a continued state of control throughout its operational lifecycle.
Key Deliverables
- Periodic Review Report
- Requalification Plan
- Continued State of Control Evidence
SERVICE HIGHLIGHT
Mock Inspections &
Audit Support
Don’t wait for the regulator to find a gap. Our “Front-Room/ Back-Room” audit support services prepare your team for the pressure of a live FDA or EMA inspection.
100%
Audit Success Rate
90+
Systems Validated
What's included in Audit Support:
- Personnel Coaching & Roleplay
- Document Room Management
- Rapid Response Validation Evidence
- Post-Audit Remediation Planning
- Observation (Form 483) Defense
FAQs
Addressing the complex concerns of quality and IT leadership.
What is audit readiness in computerized system validation (CSV)?
Audit readiness in CSV refers to the state where computerized systems, validation documentation, and data integrity controls are fully compliant and can be confidently presented during FDA, EMA, or notified body inspections. This includes up-to-date validation records, traceability, risk assessments, and Part 11 / Annex 11 compliance evidence.
How do you support organizations during FDA or EMA inspections?
We provide real-time front-room and back-room inspection support, including document retrieval, validation evidence presentation, clarification of CSV controls, and assistance in responding to inspector questions. Our support helps ensure accurate, consistent, and defensible responses during regulatory inspections.
How do you handle regulatory observations such as FDA Form 483 findings?
We assess the impact of each observation, perform root cause analysis (RCA), and develop risk-based corrective and preventive actions (CAPA). Our approach ensures responses are scientifically justified, regulator-aligned, and supported by appropriate validation and data integrity evidence.
What is retrospective validation and when is it required?
Retrospective validation is performed for existing or legacy computerized systems that were implemented without adequate validation. It involves reconstructing validation documentation, assessing system risks, and implementing remediation actions to meet current regulatory expectations without unnecessary system disruption.
How do you ensure data integrity compliance during audits?
We assess data integrity risks using ALCOA+ principles, focusing on data accuracy, traceability, access controls, audit trails, and system governance. Where gaps are identified, we implement remediation measures and controls to ensure sustained data integrity and inspection readiness.