Risk-Based Commissioning, Qualification & Validation

The design, construction, commissioning, and validation of pharmaceutical facilities present significant challenges for project managers, engineers, and quality assurance professionals. The commissioning and qualification of a new or upgraded facility are both crucial for assuring success in proceeding with validation of the manufacturing process. Before you begin validating a manufacturing process, the facility and all utilities/equipment that support these operations must be in place. Facility qualification and validation activities must provide documented evidence that the premises, supporting utilities, equipment, and processes have been designed, installed, and are operating by cGMP requirements.

Unlike manual paper-based systems, ValGenesis allows SMEs to perform a risk-based commissioning and qualification process that identifies both directly and indirectly impacted systems. Our solutions help users to identify all facility components, instruments, equipment, procedures, etc., and define deliverable requirements (individual object level or combination of objects) as per approved SOPs and processes.

Facility Commissioning & Qualification

The ValGenesis VLMS provides several advantages and benefits to any organization seeking to perform facility commissioning and qualification:

  • Develop/approve a project plan with well-defined quality gate checks for commissioning activities.
  • Conduct design reviews with risk assessment to ensure critical requirements are factored into design.
  • Perform risk-based impact assessment of systems, equipment, and significant equipment components.
  • Develop a risk-based strategy for testing and documentation requirements, whether for a system or a piece of equipment, which can be approved by all stakeholders to minimize deviations.
  • Templates can be enforced with required sections and system requirements.
  • GxP asset management with real-time validation status.
  • Validated connectors for enterprise systems including SAP, MS SharePoint, EMC Documentum, etc. to pull asset information and other related data.
  • System supports controlled document creation, review, approval, and execution of test cases.
  • Application familiarity means that very little training is required to use the system.
  • Workflow process automation reduces the effort needed for commissioning.
  • Track and manage disposition of all deviations, using best practice electronic work processes.
  • Ability to respond to spot inspections and audits quickly and easily, allowing a view of all the information available about a tag, item, system, etc. (including the entire plant) at the current level.
  • Connect and synchronize equipment inventory with requirements, risk assessments, or qualification documents.
  • Continuous monitoring of compliance throughout a project (including project-specific procedures).
  • Equipment data can be directly accessed from equipment (PLC, DCS etc.) to reduce the data integrity and time requirement for qualification and validation activities.
  • CQV deliverables form a foundation for the formal validation process.
  • The system provides a complete genealogy from CQV to OQ/PQ and enables re-usability of the contents used in CQV for all the lifecycle deliverables.



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