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The system validation specialists.
Types of Services
Commissioning and Qualification VALSPEC is a Life Sciences industry leader in the application of Risk-Based approaches to Commissioning and Qualification activities.

VALSPEC specializes in the development of approaches that align testing practices and documentation with levels of risk in terms of patient safety, process criticality, project dynamics, and computer system technologies. These approaches are developed in partnership with client project teams and with the client quality representatives as appropriate.

The VALSPEC Risk Analysis program incorporates experience from:
  • Valspec Experience with similar types of facilities and technologies
    • » Criticality assessments
    •    - System and Component Level
    • » Impact assessments
  • Broad System Life Cycle expertise
  • Industry best practices (FMECA, GAMP risk considerations)
  • Client experience
The results of the Risk Analysis are incorporated into the appropriate Commissioning and Qualification Plans. The results often include a Test Matrix which documents all required testing steps for each component of the system (Instrumentation, Process Control System hardware, network infrastructure and application software) and maps those testing requirements against the appropriate project phase (FAT, Commissioning, Qualification). This Test Matrix will dictate what level of testing will be performed and documented during which project phase based on the risks identified.

As part of a Risk-Based approach in collaboration with its customers, VALSPEC regularly leads the development and implementation of Integrated Commissioning and Qualification (ICQ), resulting in:
  • A streamlined project execution work practice
  • Elimination of non value-added work
  • Integration of Qualification requirements into the Commission Step
  • Allows for one single simultaneous execution of Commissioning & Qualification of Direct Impact Systems
  • Significant reduction in schedule and cost
Digitally enabled ICQ leverages attributes of digital technology to further reduce non value-added C&Q project execution work practice activities through the use of:
  • On-screen commissioning and calibration
  • Enhanced data integrity
VALSPEC directly employs dozens of trained engineers and consultants who have expertise in various computer-based systems and all regulatory requirements and guidelines. We have the expertise to fully commission and validate your system.

Deliverables may include, but are not limited to:
  • Validation Master Plan
  • Validation Project Plan
  • Risk Assessment Plan
  • Quality Assurance Plan
  • 21 CFR Part 11 Assessment
  • Requirements Traceability Matrix
  • Users Requirements Specification
  • Functional Requirements Specification
  • Detailed Design Specification
  • Site Acceptance Test
  • Commissioning Test Plan
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Final Validation Report
  • Standard Operating Procedures
Enabling our clients to ensure the quality of their systems through well-established methodologies, which simultaneously achieve business and compliance goals.