Computerized System Validation (CSV)
PharMarketing provides Computerized System Validation (CSV) consulting for pharmaceutical, biotech, medical device, CRO, laboratory and clinical research organisations. We help clients establish documented, risk-based assurance that regulated computerised systems are fit for their intended use and support reliable, secure and traceable records.
Our services cover systems used in clinical research, quality management, laboratories, pharmacovigilance, medical information, manufacturing support and other regulated activities.
Risk-based validation and assurance
Computerized system compliance should be proportionate to the system’s intended use, patient-safety implications, product-quality impact and data-integrity risk. PharMarketing helps organisations move beyond document-heavy validation activities by applying a practical, risk-based approach to planning, testing, evidence and lifecycle management.
Our CSV services include:
- CSV gap assessments and validation strategy development
- System inventory, intended-use and GxP-impact assessments
- Supplier and software-provider assessments
- Validation plans and lifecycle documentation
- User Requirements Specifications (URS) and functional risk assessments
- Risk-based test planning, test execution and evidence review
- Requirements traceability and defect-management support
- Change control, periodic review and system-retirement planning
- Validation remediation and inspection-readiness support
GAMP 5, Annex 11 and 21 CFR Part 11
PharMarketing supports validation programmes aligned to applicable regulatory expectations and recognised good practices, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
We can help assess and improve controls relating to:
- Electronic records and electronic signatures
- User access, roles and segregation of duties
- Audit trails, review procedures and data traceability
- Data integrity, backup, restoration and business continuity
- Change management and configuration management
- Supplier management and cloud/SaaS governance
- Security controls, incident management and periodic review
Clinical, quality and laboratory systems
We support the validation and assurance of computerised systems used across the life sciences ecosystem, including:
- Electronic Data Capture (EDC) systems
- Clinical Trial Management Systems (CTMS)
- eTMF and document-management platforms
- Safety and pharmacovigilance systems
- Laboratory Information Management Systems (LIMS)
- Quality Management Systems (eQMS)
- Learning-management and training systems
- Electronic patient-reported outcomes and digital-health platforms
- Data warehouses, integrations, reporting tools and bespoke applications
System audits, security and ISO 27001 alignment
Where appropriate, PharMarketing can integrate CSV work with system audits, supplier assessments, privacy requirements and information security controls. ISO/IEC 27001 is the internationally recognised standard that specifies requirements for an information security management system (ISMS).
We do not present ISO 27001 certification as part of CSV. Instead, we assess how information-security controls including access management, incident response, backup, supplier governance and continuity planning to support the compliance and resilience of regulated systems.
PharMarketing brings together GxP quality, data privacy and IT-compliance experience. We help organisations validate computerised systems in a way that supports patient safety, product quality, data integrity and operational efficiency.
Whether you are implementing a new eClinical platform, remediating legacy validation documentation, assessing a SaaS vendor or preparing for an inspection, we can tailor support to your system landscape and risk profile.
