Validation, Qualification and Commissioning (RC-SDLC)

Back to compliance software

Objective

Manage and support development, engineering, implementation, validation, qualification and commissioning of automated systems to ensure compliance with GxP regulations and company procedures.

RC-SDLC can be used for:

• implementation and qualification of laboratory equipment (e.g. HPLC, balances, etc.)
• engineering, implementation and qualification/commissioning of production equipment, facilities and utilities (e.g. filling lines, cleanrooms, etc.) 
• development, implementation and validation of information systems (e.g. LIMS, ERP, etc.)
• development, implementation and validation of software for medical devices
• development, implementation and qualification/commissioning of IT Infrastructure (e.g. networks, servers, etc.)

Main functionality

• Integrated Project Management
• Generate an appropriate validation/qualification/commissioning approach for a given system, based on configurable workflow
• Integrated Risk Management
• Dashboard providing an overview on the validation/qualification/commissioning process and access to the corresponding documents
• 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, incl. version management for software
• Management Reporting

Advantages

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

The product flyer can be downloaded here.