{"id":6068,"date":"2018-07-19T15:03:08","date_gmt":"2018-07-19T15:03:08","guid":{"rendered":"https:\/\/www.thermofisher.com\/blog\/analyteguru\/tips-for-validating-your-chromatography-data-system\/"},"modified":"2024-02-15T23:38:20","modified_gmt":"2024-02-15T23:38:20","slug":"tips-for-validating-your-chromatography-data-system","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/analyteguru\/tips-for-validating-your-chromatography-data-system\/","title":{"rendered":"Tips for Validating Your Chromatography Data System"},"content":{"rendered":"
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Reading through some recent U.S. FDA Warning Letters to pharma manufacturers concerning data integrity, I came across a new one<\/a> regarding a Chromatography Data System (CDS). There were a couple of very powerful sentences in the letter that companies really need to pay attention to:<\/p>\n

\u201cHowever, procuring new instruments, installing new and upgraded data acquisition software, and enabling various features on software are not sufficient alone. These steps will be effective only if you implement appropriate procedures and systems to ensure that you retain data as required…and control data and associated audit trails.\u201d<\/em><\/p>\n

This is obviously talking about the need to have standard operating procedures (SOPs) in place that describe how to use the software, and performing a validation of your CDS to demonstrate it is operating as intended. Many commercial CDS packages are 21 CFR Part 11 capable<\/em>, but in order to ensure they are 21 CFR Part 11 compliant<\/em>, the software needs to be validated after it has been configured to your specifications. Compliance, after all, comes down to having documented evidence that you are following your procedures and quality systems.<\/p>\n

Thermo Scientific\u2122 Chromeleon\u2122 Chromatography Data System (CDS)<\/a> provides validation certificates with the installation documentation. These certificates are for the validation of the software itself, but do not cover any installation. Chromeleon CDS has several built-in Station Qualification tools. These are intended to qualify the installation by checking to verify the correct files are present and that the software is operating as Thermo Fisher Scientific intended. These built-in qualifications do not, and cannot, validate that the Chromeleon software is operating as you, the end-user, intend it to \u2013 that validation must be performed separately, and can be accomplished in three steps:<\/p>\n

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    1. Determine the policies, roles, access and privileges you require.<\/strong> Chromeleon CDS can be configured in many different ways depending on your internal requirements. Common areas to think about include:\n