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The system validation specialists.
Types of Services
Quality Governance With the increasing movement of the industry into advanced project philosophies, such as Risk-Based Approaches to Commissioning and Qualification and Integrated Commissioning and Qualification, new challenges present themselves to project teams that are attempting to adopt the best methodologies while maintaining project commitments and goals. VALSPEC offers a unique set of Quality Governance Services that serve to ensure just that for our clients.

VALSPEC Quality Governance Services tie together all of the important aspects of a project so that Quality is built into the processes and methodologies, resulting in:
  • Reduction and/or elimination of testing and documentation redundancy associated with typical commissioning and qualification scope
  • Successful implementation of Risk-Based testing approaches
  • Higher Quality documentation packages from OEM Suppliers
  • Reduction in overall system implementation cost
  • Schedule compression
Our Quality Governance Team provides the following services to ensure that these results are achieved:
  • Create or modify Master Validation Plans and Validation Project Plans to document project methodologies
  • Conduct Risk-Based Analysis of systems to determine testing strategy during each phase of the project
  • Create a Test Matrix across all system components (hardware, network, software) that identifies the most efficient testing paths
  • Define the elimination or significant reduction of redundant testing of the system by leveraging early testing results against qualification requirements; ensuring that early testing results that will be leveraged are documented in a quality manner
  • Evaluation of project efficiency and system maintenance tools to determine potential for use on projects; develop project execution methodologies with respect to the use of these tools
  • OEM Vendor Management
    • » Perform Quality System audits on suppliers
    • » Manage Computer Systems Qualification documents for vendor-supplied systems
    • » Define elimination or significant reduction of redundant testing of the system by utilizing an appropriate level of vendor documentation outputs as input into qualification requirements
  • Facilitate Enhanced Design Review and Team Protocol Reviews
  • Ensure compliance with the project plans
  • Perform in-process audits
  • Develop and maintain Requirements Traceability Matrix
  • Develop and maintain change control program
  • Implement in-process strategy adjustments as needed
Systems
Industries
Services
Enabling our clients to ensure the quality of their systems through well-established methodologies, which simultaneously achieve business and compliance goals.