Validation

Equipment validation is a process by which  a set of  procedures are used to check if a product meets the specifications and requirements of its intended use and these procedures are properly put together in a document called the "Validation Protocol".

At BSM Technics we carry out an intense validation that will leave our customers confident with their equipment knowing that they have documented evidence of their fit for purpose. In order to fulfil that for our valued customers, the following procedures make up our overall validation process;

  • Installation Qualification (IQ):  This is fulfilled by following a protocol  designed to verify the proper installation and configuration of an equipment and its Operation  System. During this process we also ensure that necessary files have been loaded, equipment has been installed and tested. 

  • The Operational Qualification (OQ):  The protocol  here is a set of test used to verify the proper functionality of the equipment and the processes it is designed to run. Operational Qualification is mainly focused on the design and functionality of the unit or equipment and is usually performed when the unit is not loaded  or released for use.

  • Performance Qualifications (PQ):  This protocol outlines a series of tests to be carried out to verify that a system performs as expected under real user conditions. In this instance the equipment is put under real everyday use programs and the results are documented as evidence of the fitness for purpose​ of the unit. Please NOTE; Performance Qualification is normally the responsibility of the customer as they know the processes that they run and we can help to monitor the programme, keeping a record of the parameters at work during the process.

Most of our customers who request for equipment validation usually do this when they have bought new equipment and they want to ensure that after installation their equipment still performs as validated during a Factory Acceptance Test as anything can happen from the time the unit leaves the factory to the time of intended use that can compromise the reliability of an equipment. Customers can also choose to have a validation done periodically, or a validation can also be booked  as and when the customer needs it. 

 

At BSM Technics, we carry out validations on a number of thermal equipment and the following are examples;

  • Fridges/Freezers

  • Incubators

  • Ovens

  • Stability Cabinets

  • Temperature Monitoring Systems.

What is included with Validation?

After the validation of each unit, the following are issued;

  • Calibration Certificate for each calibration carried out during the process.

  • A completed Validation Protocol (in form of a file or folder - hard & soft copies) with all the documented evidence of the data accumulated during the execution of the Validation Protocol.

  • Technical advise/Recommendations if needed.

  • A Validation Sticker affixed to the unit.

 

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