Be audit-ready with Viedoc Inspection Readiness Packet

Be prepared for every audit and inspection with Viedoc’s Inspection Readiness Packet (VIRP)—a comprehensive resource designed to help you comply with regulatory guidelines and ensure your clinical trial systems and documentation are always inspection-ready. 

Regulatory bodies demand more than ever—complete transparency, rigorous system validation, and meticulous documentation. VIRP simplifies these complexities, equipping you with the tools and insights needed to confidently navigate audits and ensure seamless compliance. 

Regulatory compliance made simple 

VIRP is designed to help you meet the expectations of major regulatory authorities, including: 

• EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials: Align with requirements for validation, documentation access, and risk assessments. 
• FDA Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations (Q&A): Ensure data integrity, system validation, and adherence to retention policies.
• PMDA Expectations: Maintain robust data quality and procedural documentation using standardized tools.
  
  With Viedoc, you can confidently rely on our detailed validation processes and compliance documentation to meet global standards. 
  
  

Why this PDF? 

This PDF provides an overview of VIRP and how it supports your inspection readiness. The complete VIRP is available to customers to download from within Viedoc Admin.