Qualification and Validation Services That Support Inspection Readiness
Qualification and validation services play a critical role in maintaining product quality, data integrity and regulatory compliance across pharmaceutical, biotech and medical device operations. Regulatory agencies expect documented evidence that facilities, utilities, equipment and processes perform as intended. When qualification or validation gaps appear, inspections stall, approvals are delayed and enforcement risk increases.
FDAQRC delivers qualification and validation services designed to help you meet FDA and global regulatory expectations with confidence. With deep pharmaceutical and device validation expertise and a white-glove (customizable) consulting model, FDAQRC strengthens compliance, supports inspection readiness and reduces operational risk across your quality systems.
Comprehensive Qualification and Validation Services
Effective qualification and validation programs require technical precision, clear documentation and alignment with current regulatory guidance. FDAQRC provides end-to-end qualification and validation services tailored to your operations, product life cycle and regulatory footprint.
FDAQRC applies risk-based methodologies to support the qualification and validation of the facility, utility and equipment. This strategic approach ensures validation activities focus on systems that directly impact product quality and patient safety.
Leverage these three services to improve operational efficiency while maintaining compliance with FDA and international standards.
1. IQ, OQ and PQ Validation for Regulated Environments
Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) form the foundation of compliant systems and processes. FDAQRC supports IQ, OQ and PQ validation across manufacturing, laboratory and support systems to confirm each element performs as designed under real-world conditions.
Receive clear protocols, executed testing and defensible validation reports that withstand inspection scrutiny. FDAQRC aligns validation documentation with regulatory expectations, helping demonstrate control, consistency and compliance during audits.
2. Cleaning Validation Pharmaceutical Expertise
Cleaning validation pharmaceutical programs protect against cross-contamination and ensure equipment cleanliness meets regulatory thresholds. FDAQRC supports cleaning validation strategy development, protocol execution and remediation following inspection findings.
Services address worst-case assessments, acceptance criteria, sampling methods and data evaluation. By integrating cleaning validation into the broader quality framework, FDAQRC helps reduce contamination risk and supports uninterrupted manufacturing operations.
3. Laboratory Equipment Qualification and Data Integrity
Laboratory equipment qualification remains a key focus area for inspectors due to its direct impact on testing accuracy and data reliability. FDAQRC provides lab equipment qualification services covering analytical instruments, environmental monitoring systems and controlled storage equipment.
FDAQRC supports qualification planning, execution and documentation while aligning with data integrity expectations. When appropriate, FDAQRC leverages industry-standard tools, including FDA-aligned monitoring solutions, to support compliant temperature mapping and continuous monitoring programs.
Pharmaceutical Validation Services Backed by Global Expertise
FDAQRC delivers pharmaceutical and device validation services through a vetted global network of more than 500 consultants supported by a strong internal project management team. This model enables rapid deployment of subject matter experts with direct experience supporting FDA inspections and global regulatory audits.
Whether you need proactive validation planning or remediation following an inspection, FDAQRC provides responsive, hands-on support that integrates seamlessly with your internal teams. The result is a practical validation program that supports compliance without disrupting operations.
Start Your Qualification and Validation Engagement
Qualification and validation readiness directly impacts inspection outcomes, product approvals and business continuity. FDAQRC delivers qualification and validation services that help you demonstrate control, maintain compliance and move forward with confidence.
Request a consultation to discuss your pharmaceutical validation needs or laboratory equipment qualification support.
Request a Consultation