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RC-SDLC can be used to support and manage implementation and qualification of laboratory equipment (e.g. HPLC, balances, etc.) to ensure compliance with GxP regulations and company procedures.

Main functionality

  • Generate an appropriate qualification approach for a given system, based on configurable workflow
  • Integrated Risk Management
  • Dashboard providing an overview on the qualification process and access to the corresponding documents, incl. URS, qualification protocols, etc.
  • Document and version management
  • Automated workflow for generation, review and approval of documents
  • Content management, incl.
    • definition and linking of requirements, risk items and test cases
    • possibility to manage content of templates and deliverables in MS Word
  • Integrated requirement and test management
  • Library for definition and inheritance of default requirements and test scripts
  • Design Assistance
     - View documents of similar systems
     - Import requirements and test scripts from existing documentation or library
  • Supplier Assessment & Selection
  • Automated Traceability Matrix
  • Test registration (incl. documented evidence) and defect handling
  • Change Control
  • Management Reporting

Advantages

  • GxP compliant qualification
  • Centrally and readily retrievable documentation
  • Efficient document review and approval through automated workflow
  • Consistent and adequate qualification through standardization of approach, documentation and content
  • Speeding up of the qualification process through reuse of content
  • Paperless compliance
  • 21 CFR part 11 and Eudralex Annex 11 ready

The product flyer can be downloaded here.