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IQ OQ PQ

Some laboratories use validation and qualification somewhat interchangeably.

 

We recognize that “Validation” requires more than the software/hardware system that creates reports after data acquisition. Essentially this procedure provides for IQ/OQ and on a continuing basis PQ facilities. This on site service provides a documented validation of the Chromperfect systems for internal or external audits.

 

The process generally addresses a number of processes and documents the installation, operation and performance of your Chromperfect system. If you perform chromatography in a regulated environment, validation of your CDS is essential. We provide a service which uses a variety of tools necessary to ensure data integrity. The on-site service and testing is performed by one of our specialists. They will perform a series of test to check, test and document the following:

 

  • Access control - to detail and document the user and group management as installed detailing the privileges and access to data

  • Electronic signatures and “reason for change” implementation

  • Certificates

    • Installation detailing the various files and software modules that have been installed and validating the confirmation of their validity

    • System suitability documentation of a variety of tests to detail system performance when measured against published results

    • Hardware validation - a report which details the results from a series of tests of the Chromperfect hardware using a certified device

    • Auditing - A report which details a series of functions during testing using Chromperfect native auditing and history tools

  • A comprehensive report and certificate for each Chromperfect system tested.

Chromperfect Validation services

Validation

Contact our team to
discuss your requirements

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