Equipment Validation Explained

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SOURCE:http://www.rscal.com/equipment-validation-explained/

 

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.

IdeaEssential Sections of Any Validation Plan

Validation Process

Instrument validation begins with a validation master plan that defines the steps in each process. Traditionally, these steps can be categorized into 5 separate qualification categories (DQ IQ OQ PQ CQ), which include:

  • Design Qualification (DQ) – The first step is to demonstrate whether the proposed design of the instrument can cope with the functional requirements of the end user. A proposed design must satisfy the DQ before construction and procurement of parts.
  • Installation Qualification (IQ) – The instrument, with all its components and documentation, is placed correctly and checked for performance according to the requirements.
  • Operational Qualification (OQ) – All the major parts of the instrument are tested to ensure they all perform correctly and are in sync with the entire system.
  • Performance Qualification (PQ) – The instrument is monitored over a period of time to check if it consistently delivers results within the required parameters.
  • Component Qualification (CQ) – Auxiliary components and parts that are sourced from a third-party manufacturer are periodically subjected to random tests for quality and performance to ensure they are manufactured to the right specifications and won’t hamper the performance of the instrument.

Benefits of Equipment Validation Services

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. Let’s look at the detailed benefits of validation services below:

  • Your validation and quality checking processes may include unnecessary tests and procedures, which add to your delivery time and waste labor resources.
  • A validation service can provide a standardized methodology to optimize the validation lifecycle to cover only the required steps and checks.
  • Equipment validation services can provide documented independent verification and validation of your system’s performance.
  • Purchasing equipment for validating products can be a costly venture. A validation service can offset the cost, without jeopardizing the end results. Experienced and qualified staff for managing your validation process is also expensive.
  • Experienced validation services can perform routine checks to further improve your process and prevent lapses in quality.
  • Just like any other industry, there are a range of certifications and compliance norms for service providers, so
    you can be sure of what to expect.

Validating your products might seem like a long, drawn-out process, but there’s a good reason for it. If you can ensure your products perform consistently and meet all the requirements of the industry, the value of both the product and your brand increases, and that’s always a good thing!

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