Compliance & Validation

Compliance & Validation

Many XiltriX installations are in laboratories operating in highly regulated environments, where compliance and validation is an essential part of the implementation of the system. This is a multi-step process, and XiltriX can assist during every stage.

URS and Functional Specifications

XiltriX provides the necessary User Requirement Specification (URS) and Functional specification documentation to initiate the validation process. These documents are compared to the needs and requirements of the customer. The results of this exercise will be reported in a Review document which is the first step of the validation process. Any subsequent changes will be recorded in the Change request documents provided. This part of the process is oftentimes known as DQ (Design Qualification).

Installation Qualification (IQ)

After installation, Installation Qualification (IQ) documents will be completed that record in detail all necessary product information: part numbers, serial numbers, delivery dates, version numbers, and so on. The manner in which the XiltriX installation was performed is also recorded in great detail. The finished IQ documents provide a blueprint of how the complete system has been installed, detailing all components. The IQ documents are the second part of the validation report.

Operational Qualification (OQ)

The next step is to prepare the Operational Qualification (OQ) template to confirm that the system complies with the functional specifications. This describes all necessary tests, and provides printed proof that the complete XiltriX installation performs to optimum specifications. The finished OQ is recorded in a Review document that is also part of the validation report.

Performance Qualification (PQ)

Finally the customer will regularly perform a Performance Qualification (PQ) exercise in order to prove that XiltriX continues to perform correctly, on a daily basis under normal working conditions. We can provide documents and procedures to facilitate and largely automate the PQ process with any test results are archived by the XiltriX solution.

Validation Report

The complete validation report will contain all the above documents and the printed evidence to show auditors that XiltriX complies with the appropriate accreditation regulations and compliance.

If you would like to know more about XiltriX, let me know.

Han Weerdesteyn

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