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, safety
checks and the like, for a wide range of products.

The Importance of Equipment Validation

In precision instruments, lab equipment or specialized machinery, even minor
inaccuracies can cause problems and lead to inaccurate or incomplete results.

Equipment validation ensures your product will consistently perform within a

given range. Most consumers look for certification from quality management
systems, like ISO, before they even consider buying a product; so an incorrect
system of validating your equipment can threaten your adherence to industry
norms, as well as your certifications and compliances.

Different Aspects of Equipment Validation

Here are some of the protocols that need to be kept in mind for successful equipment validation:

• Documentation Availability – All the documentation that is required should be

verified and made available. This includes electrical schematics, mechanical
and instrument drawings, utility and supply ratings, spare parts lists, and such.
• Component and Design Verification – The design of the equipment and its
components should be verified in accordance with specifications and
verification norms.
• Electrical Connections and Supply – All the electrical connections and the
power supply to the equipment needs to be checked thoroughly before you
begin the validation process.
• Utility Supply – Hydraulic, pneumatic, and other input supplies, as well as the
connections, should be verified for quality and checked for leaks.
• Safety Compliance – Safety checks should be tested and noise levels should
be within applicable standards. Electrical connections and fail-safes need to be
checked and tested, and the wiring needs to be checked for leaks. Radiation
and interference levels should be within acceptable limits too.
• Critical Instrument Calibration – Any sensors or monitoring instruments need
to be calibrated correctly. The accuracy of primary monitoring instruments and
controls should be within the limits of traceable standards, and the resolution
should be within the required range.
• Environmental Verification – Instruments need to be checked for operation in
various environments. This includes testing within the required ranges of
temperature, humidity, light, electrostatic discharge isolation, and other
conditions.
• Standard Operating Procedures – SOPs for various procedures should be
available, like cleaning, periodic maintenance, software configuration, disaster
recovery, etc.
• Instrumentation for Validation – The instruments used to validate the
installation qualification should be listed and should be within the due date for
re-calibration

These are just a few things that almost every validation process should
incorporate. Depending on the industry the instruments are built for and the
individual requirements of the validation, other aspects might also need to be
taken into account.