CSV audit capabilities
We support clients across the entire pharma ecosystem by providing:
Vendor qualification and requalification audits
Independent audits conducted prior to vendor selection and at defined intervals, assessing validation status, governance and ongoing compliance.
Software Development Life Cycle (SDLC) review
Detailed evaluation of development processes, including requirements, testing, traceability, change control and release management.
SaaS and hosted system oversight
Assessment of validation approaches where systems are externally developed and hosted, including review of roles, responsibilities and service agreements.
Data integrity and IT security assessment
Evaluation of access controls, data hosting arrangements, security frameworks and controls supporting regulated data.
Regulatory compliance review
Alignment to FDA 21 CFR Part 11 and applicable global regulations, ensuring electronic records and signatures meet inspection expectations.
Quality issue and defect investigation support
Independent review of system-related deviations, recurring errors or bug fixes and conduct of thorough root cause analysis to confirm appropriate remediation.
Risk-based validation assessment
Evaluation of risk assessments to ensure system functionality is proportionate to GxP impact and regulatory exposure.
Integrated multi-GxP system auditing
CSV expertise embedded within broader GxP audits — ensuring computerized systems supporting clinical, laboratory, manufacturing or distribution activities are appropriately validated.
