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
CCO

XiltriX Brochure 2022 Thumb

XiltriX. Protecting your Science
24-hours a day, 7-days a week.

White Paper – The Ultimate Guide to Dewar Monitoring and Alarm

Dewars are the standard for long term tissue storage in many laboratories. This is the Ultimate Guide to Dewar Monitoring and Alarm.

Case Study – XiltriX Monitoring Past to Present; Lessons Learned in 20 years, ETZ IVF Tilburg

The ETZ IVF laboratory replaced its low O₂ box type CO₂ incubators with Miri benchtops. XiltriX in use for for 20 years was also upgraded.

XiltriX International company meeting March 2023

As a company XiltriX International has experienced a rapid growth both nationally as well as internationally; time to come together.

“In fact it would be relevant to mention that through XiltriX we could ascertain that one of our platelet
agitators suddenly stopped working therby we were able to prevent product loss.”

Dr Rema Menon
Blood bank Medical Officer
Apollo Hospitals Ltd., Chennai, India

Are you interested in eliminating liability during your
scientific processes?

Learn how XiltriX can protect your Science.

© Copyright - XiltriX International