Services

Modern R&D processes are increasingly intertwined with computerised systems and cutting-edge IT-based clinical tools. Without proper management, these technologies pose a significant threat to the regulatory integrity of vital data, crucial document authenticity, and the security of networks and applications.

The team of Computer System Validation (CSV) specialists at SPGL is equipped to collaborate with your organisation, ensuring that both you and your vendors establish or enhance a robust System Development Life Cycle (SDLC). Alternatively, we can craft and deploy an SDLC tailored specifically for your organisation.

Our goal is to ensure that your validation audits are not only regulatory-compliant but also meaningful and effective in pinpointing critical issues. We achieve this by performing thorough audits, both internally and at your vendors’ sites, on your organisation’s behalf.

In keeping pace with the growing complexity and ubiquity of networks and applications, regulatory bodies now commonly expect organisations to conduct comprehensive CSV process audits, in addition to validation audits.

SPGL is here to guide you through these expanded requirements, ensuring thorough oversight and adherence to these new regulatory standards.

Our range of CSV services encompass:

Computer system validation audit

• System specific computer system validation audits
  • Data centres
  • Back and data recovery
  • Business Continuity and disaster recovery
  • IT security
• 21 CFR compliance GAP analysis
• Computerised System Development Life Cycle (SDLC) process audits
• All aspects of system and application planning and development processes and change control
• CSC GAP analysis