GxP Audits
Tower Mains helps life sciences organisations worldwide strengthen quality, manage compliance risk and navigate increasingly complex regulatory expectations. Our specialist auditors support pharmaceutical, biotech, healthcare, medical device, research and scientific organisations with the expertise needed to assess GxP compliance across their operations.
From individual supplier and facility audits to complex global audit programmes, we provide clear findings, practical recommendations and a proportionate approach tailored to your organisation’s needs. Our audits help identify risks, strengthen controls and support effective oversight and inspection readiness.
Overview of our GxP audit services
GxP audits provide a structured, independent assessment of systems, processes, facilities and third-party providers to verify compliance with Good Practice requirements, including GCP, GLP, GCLP, GMP, GDP and applicable medical device requirements.
Audits can identify compliance gaps, potential risks and opportunities for improvement while supporting data integrity, patient safety, product quality and operational control across clinical, laboratory, manufacturing and distribution environments.
Why audit and GxP compliance matter
Effective GxP compliance is essential for maintaining confidence in regulated activities and meeting evolving global regulatory expectations. Without appropriate oversight, organisations may face regulatory findings, operational disruption and increased compliance risk.
Common challenges include:
Inefficient or undocumented processes increasing compliance and operational risk.
Limited internal resources or specialist expertise to deliver effective audit programmes.
Data integrity issues affecting research, laboratory, clinical and manufacturing activities.
Delayed remediation increasing the risk of corrective actions, audit delays or programme disruption.
GxP audit services
Tower Mains provides specialist GxP audit services across the life sciences sector, helping organisations maintain effective oversight throughout the product lifecycle. We design and deliver audit programmes aligned with global regulatory requirements, using a practical, risk-based approach tailored to each organisation’s needs.
Our expertise spans GCP, GLP, GCLP, GMP, GDP and medical devices, with audits covering suppliers, vendors, facilities, processes, systems and outsourced activities. Whether you require a targeted assessment or an ongoing audit programme, we provide the technical expertise and practical insight needed to evaluate controls, address risks and strengthen quality management.
GCP audits are a critical part of the quality assurance framework for clinical trials, helping sponsors, CROs and healthcare organisations maintain compliance with ICH GCP requirements and global regulatory expectations.
We deliver GCP audits across investigator sites, CROs, vendors, clinical systems and trial documentation. Whether performed remotely or on-site, our audits provide an objective assessment of clinical activities, with a focus on trial oversight, data integrity and the effectiveness of quality controls.
GCP audit services include:
- Investigator site audits (Phase I–IV)
- System & vendor audits
- Trial Master File (TMF) audits (paper and electronic)
- Computer System Validation (CSV) audit
- Data management audits
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Maintaining GLP compliance is essential for ensuring the integrity, reliability and credibility of nonclinical research data. Tower Mains provides independent GLP audits across test facilities, laboratories, suppliers and study activities, assessing systems and processes against applicable regulatory requirements.
Our audits assess the controls supporting nonclinical research, helping organisations identify compliance gaps, strengthen oversight and maintain confidence in the integrity of their data and study activities.
GLP audit services include:
- Vendor audits, including CROs and pre-clinical facilities
- Facility, process and system audits
- Test facility/site audits
- CSV audits
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Maintaining GCLP compliance is essential for ensuring the quality, integrity and reliability of laboratory activities that support clinical research. Tower Mains provides independent GCLP audit services to assess laboratory processes, systems and documentation against applicable regulatory and quality requirements.
We assess clinical laboratories and supporting activities to review laboratory controls, documentation, data integrity and compliance with applicable requirements. Our audits provide objective insight into laboratory practices supporting clinical research, helping identify areas for improvement across laboratory operations and quality systems.
GCLP audit services include:
- Vendor audits, including biomarkers, immunoassay and bioanalytical
- CSV audits
- Study audits, including plans, amendments, critical phases, raw data and final report
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Compliance with GMP and GDP is essential to ensuring that pharmaceutical manufacturing, storage and distribution operations meet global regulatory requirements and maintain product quality across the supply chain. Tower Mains provides independent GMP and GDP audit services to assess manufacturing operations, quality systems, suppliers and distribution activities against applicable regulatory expectations.
We review key areas including manufacturing processes, quality control, supplier oversight, outsourced activities, documentation, storage and distribution practices. Our audits provide an independent assessment of the controls supporting product quality across manufacturing and supply operations, identifying gaps and areas for improvement.
GMP/GDP audit services include:
- Vendor audits from development through to commercialisation
- Storage and distribution centre audits
- Marketing Authorisation Applications / Common technical document submissions
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Maintaining compliance across the medical device lifecycle is essential for ensuring product quality, patient safety and regulatory readiness. Tower Mains provides independent medical device audit services to assess supplier controls, quality management systems and operational processes against applicable regulatory requirements.
We assess device-related activities, outsourced processes and supplier arrangements, with a focus on the effectiveness of quality controls and the management of critical activities across the device lifecycle. Audits can be used to assess current arrangements, identify gaps or provide additional assurance ahead of regulatory submissions, inspections or key supplier decisions.
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Tower Mains provides remote and hybrid GxP audit solutions for organisations seeking flexible, efficient and risk-based approaches to audit delivery.
Remote audits can be particularly effective for supplier qualification, document and data reviews, electronic systems, computer system validation and audit follow-up activities. They enable effective oversight across global operations while reducing travel, operational disruption and the time required to coordinate on-site audits.
Where appropriate, remote audits can be combined with targeted on-site activities to create a proportionate approach based on the scope, risk and requirements of the engagement.
Remote and hybrid GxP audits include:
- Electronic system vendor audits
- Computer system validation audits
- Data and report audits
- Vendor qualification audits
- Sponsor system and process audits
- Document audits
- Investigator site audits
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.
