Equipment validation is a term used to describe a set of independent procedures that are used to check if a product meets the specifications and requirements of its intended purposes.  Regulatory agencies around the world have strict requirements for quality, procedures, performance testing and safety checks, for a wide range of products.

The Importance of Equipment Validation

With precision instruments, lab equipment or specialized machinery, minor inaccuracies can cause problems and lead to inaccurate or incomplete results.  Equipment validation ensures your product will consistently perform within a given parameter.  Most consumers look for certification from quality management systems, like ISO, before they consider purchasing a product. 

Protocols
To be kept in mind for successful Equipment Validation 

  1. Documentation Availability
  2. Component and Design Verification
  3. Electrical Connections and Supply
  4. Utility Supply
  5. Safety Compliance
  6. Critical Instrument Calibration
  7. Environmental Verification
  8. Standard Operating Procedures
  9. Instrumentation for Validation 

Validation Process

Instrument Validation begins with a validation master plan that defines the steps in each process.

  1. Design Qualification (DQ)
    1. A proposed design must satisfy the DQ before construction and procedure of parts.
  2. Installation Qualification (IQ)
    1. The instrument and all its components and documentation are placed correctly and checked for performance according to the requirements.
  3. Operational Qualification (OQ)
    1. All the major parts of the instrument are tested to ensure they all perform correctly
  4. Performance Qualification (PQ)
    1. The instrument is monitored over a period of time to check it is consistently delivering results within the required parameters.
  5. Component Qualification (CQ)
    1. Components and parts that are sourced from a 3rd party manufacturer is periodically subjected to random tests for quality and performance to ensure they are manufactured to the right specifications.

Creating a calibration process that encompasses all the requirements can be time-consuming and cumbersome.  Validation Services can help you save both time and money by streamlining your validation procedures. 

As a leader in Scientific Equipment Repair and Medical Equipment Calibrations, Scientific Instrument Center works with many corporations, universities, and hospitals providing the highest level of laboratory services. Whether we are providing biosafety cabinet calibration or medical equipment calibration, we keep your equipment performing to industry codes and regulations. Feel free to contact us using our contact form or give us a call at (614) 771-4700