RC - VLM

Validation Lifecyle Management

Challenges of the industry

Up-to-date overview of:

  • systems and configurations
  • system validation state
  • (progress of) validation processes
Maintain validated state during full life cycle
How to keep it efficient:

  • Bureaucracy, generating too much paper
  • Project going out of time/budget limits
  • Frustrated review and approval process
  • When have you done enough?
  • Re-use of good practice examples
  • Traceability and consistency between physically separated documents and content

Objective of RC-VLM

  • Control, support and integrate compliance processes for systems, incl. facilities, utilities, equipment, information systems and IT infrastructure
  • Efficiently establish, maintain and demonstrate GxP-compliance throughout their entire life cycle
  • Enable paperless validation and compliance
  • Increase maturity of system development, implementation and management
COMPLIANCE & QUALITY MANAGEMENT SOFTWARE Request free Demo
COMPLIANCE & QUALITY MANAGEMENT SYSTEM

Basic principles of RC-VLM

  • Cover the full system life cycle
  • Configurable according to the company’s compliance approach
  • Supply maximum support for a given system
  • Focus on execution as well as documentation
  • SaaS solution
  • Adaptive user interface
  • Based on US and EU regulations, incl. 21 CFR part 11 and Eudralex volume 4 annex 11
  • Support different standards e.g. PIC/S, GAMP, IEEE, Cobit, ITIL, ISO, etc.
  • 21 CFR Part 11 compliant
  • Modular approach; no need to implement all modules at once
  • Webbased application (.Net) with SQL Server
  • Current version: 3.6
RC-VLM DIAGRAM

Find more details about the RC-VLM DIAGRAM Here