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Systems Validation

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Submitted By Ranazole
Words 1134
Pages 5
Name: Gerard White

ID number: X00107665

Date: 24/6/2013

Title: Systems Validation Assignment

1. Outline the typical testing that is conducted when executing an IQ protocol.

Once the process equipment or systems have been designed and selection has been completed it is necessary to perform tests to ensure that the equipment or systems supplied are installed as specified based on the manufacturers, contractors or designers specifications and drawings. It is about establishing confidence that all of the equipment or systems used in the manufacturing process meet the specified requirements and are appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use. It is also necessary to validate that all the critical training has been provided for the operation of the equipment or process.

There are a number of tests and checks required when executing the installation qualification protocol and they are as follow:

1) Examining the equipment or process design. This involves documenting all the hardware systems supplied with regards to the model and serial numbers whilst performing visual checks on all of the equipment. Checking the supplied software, referencing and documenting the program number and title, the version number and last date modified. Also checking the back up software and documentation supplied. The key documents that would need to be referenced for these checks are the User Requirements specifications, the Functional specification and the design qualification.

2) The examination of material certifications for any parts coming into direct contact with the product being produced. Involves examining the materials of construction list and lubricant list to identify and obtain the required material certifications. Identifying any important elements of

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