Good Clinical Laboratory Practice (GCLP) Audit Services
Tower Mains provides specialist GCLP audit services to help organisations maintain the quality, integrity and reliability of laboratory activities supporting clinical research. Our independent, risk-based assessments help clinical laboratories, sponsors and research organisations evaluate laboratory processes, systems, documentation and data against applicable GCLP and regulatory requirements.
From central laboratories and specialist testing providers to laboratory systems, study documentation and data management processes, our experienced auditors identify compliance gaps, assess potential risks and provide practical recommendations to strengthen oversight and support inspection readiness.
Why GCLP audits matter
A robust GCLP audit programme helps organisations maintain confidence in clinical laboratory data, strengthen quality systems and ensure laboratory activities supporting clinical research meet applicable regulatory and quality requirements. Without appropriate GCLP oversight, organisations may face:
Data integrity, traceability or documentation concerns.
Inconsistent laboratory processes or quality system weaknesses.
Regulatory findings during inspections or study reviews.
Delays to clinical development programmes and increased corrective action requirements.
Tower Mains helps organisations proactively identify and address these risks through independent GCLP audits, providing clear insight and practical recommendations to strengthen laboratory compliance, data integrity and inspection readiness.
Our GCLP audit services
Tower Mains provides flexible GCLP audit solutions to support sponsors, clinical research organisations and laboratory providers involved in clinical development. Our audits are tailored to your requirements and delivered using a risk-based approach aligned with GCLP principles and applicable regulatory expectations.
Vendor Audits
- Central laboratories
- Biomarkers
- Immunoassay
- Bioanalytical
Computer System Validation (CSV) Audits
Study Audit
- Study plan/amendments
- Critical phase
- Raw data
- Final report
Our GxP audit process
Tower Mains applies a practical, risk-based approach to GxP auditing, ensuring each audit is delivered by a specialist with the appropriate technical expertise and regulatory knowledge.
1. Understanding your requirements
We begin by understanding your objectives, audit needs, timelines and key areas of focus.
2. Selecting the right GxP auditor
We assign an auditor with relevant GxP expertise, industry experience, technical knowledge and an understanding of your specific requirements.
3. Preparing for your audit
Your auditor prepares the audit plan, agenda and documentation requirements.
4. Conducting the audit
Audits are performed remotely or on-site through interviews, document reviews and assessment of relevant systems, processes, facilities, suppliers or studies.
5. Delivering clear audit outcomes
You will receive a comprehensive audit report, prepared using your preferred format or our own template, detailing observations, findings and practical recommendations for improvement.
6. Follow-up and ongoing support
Where required, we provide follow-up activities including CAPA review, re-audits and additional quality assurance support.
Why choose Tower Mains?
Global GxP Expertise
Access experienced auditors, quality professionals and subject matter experts across the GxP landscape, from clinical and laboratory environments to manufacturing, devices and research. We bring industry experience and specialist insight to help you address quality and compliance priorities.
Regulatory and Technical Insight
Our team brings extensive, real-world experience across global regulatory frameworks, including ICH, FDA, EMA and MHRA requirements. We help organisations interpret regulatory expectations, focus on what matters, assess risk and make informed quality decisions with confidence.
Flexible Quality Solutions
From single audits and annual audit programmes to vendor oversight, QA support and inspection readiness, we provide the right support for your objectives and risk profile. Services can be delivered in person, remotely or through a hybrid approach.
Practical. Proportionate. Collaborative.
We believe quality should enable your organisation, not add unnecessary complexity. Working alongside your teams, we bring an objective perspective, provide constructive challenge and help strengthen quality systems through sustainable improvements.