Life Sciences Audit Services

PharMarketing provides independent audit services for pharmaceutical, biotech, medical device, CRO and clinical research organizations across the EU and internationally. We assess quality systems, clinical operations, computerised systems, data processes, information security and privacy controls to help organisations identify compliance risks, strengthen governance and prepare for inspections, partnerships or transactions.

Our auditors combine life sciences expertise with practical experience in GxP, clinical research, IT, data protection and vendor oversight.

Audit Services We Provide

CRO, Vendor and Supplier Audits

Outsourcing does not remove your responsibility for quality, compliance, patient safety or data integrity. PharMarketing conducts risk-based audits of third parties supporting your operations, including:

Contract research organisations (CROs)
Clinical data management providers
Pharmacovigilance and safety vendors
Medical information service providers
Software-as-a-service and clinical technology providers
Laboratories, specialist consultancies and other subcontractors
Data processors and other privacy-relevant suppliers

Our audits help sponsors assess whether vendors have suitable processes, documentation, controls and corrective actions in place before engagement or during an ongoing relationship.

GxP, Quality and Clinical Operations Audits

We perform audits across core life sciences processes to support compliance, inspection readiness and continuous improvement.

Our audit scope can include:

Quality assurance and quality management systems
Clinical trial management and clinical operations
Clinical data management processes
Pharmacovigilance and drug-safety processes
Medical information processes
Computerised system validation (CSV)
Data integrity and electronic records
Data protection and privacy governance

Good Clinical Practice is an international ethical and scientific quality standard for designing, recording and reporting clinical trials involving human participants. Sponsor audits are distinct from clinical trial monitoring and form part of an effective quality oversight model.

IT, Cybersecurity and Data Protection Audits

Digital systems supporting clinical research and regulated operations must be secure, reliable and appropriately governed. PharMarketing delivers IT and privacy audits designed to assess operational, technical and compliance risks upon requests collaborating with information and cyber security experts.

Services include:

General IT control audits
Detailed IT infrastructure and application audits
IT security and cybersecurity assessments
Data governance and data-protection audits
Access-control, backup, business-continuity and incident-management reviews
Review of supplier security controls
Privacy and GDPR compliance assessments
ISO/IEC 27001 Readiness Assessments

Our Audit Methodology

Each engagement is tailored to the organisation, process, system or vendor being assessed. A typical audit includes:

Scoping and risk assessment to define objectives, applicable requirements, systems, locations and documentation.
Kick-off meeting and audit plan to align stakeholders, agenda, evidence requirements and timelines.
Document review and questionnaires to assess procedures, records, system controls and governance.
Interviews and audit activities conducted remotely or on site, as appropriate.
Close-out meeting to discuss preliminary observations, critical risks and agreed next steps.
Audit report and CAPA support with documented findings, risk-based recommendations and support for corrective and preventive action planning.

PharMarketing brings together quality, clinical research, IT security and privacy expertise—helping life sciences organisations avoid fragmented assessments that overlook how systems, data, suppliers and regulated processes interact.