Audits, Brian and Chromeleon CDS – as Easy as ABC!

[brian-alliston]

This is the first installment of a regular blog post where Brian Alliston, Data Integrity Expert and CDS Specialist, from Sterling Pharma Solutions shares his on-going experiences with Chromeleon CDS. The aim of this post is to share some of Brian’s learning, knowledge, tips and endeavors, and to promote discussion on topics including:

• Experiences receiving external and internal audits


• Controlling manual integration and monitoring usage


• Reviewing data and audit trails


• Best practices for file names & folder structures


• Use of eWorkflow™ procedures and eSignatures to streamline work


• Report templates and data queries for data analysis


• Evolving regulatory requirements

Over to Brian for the story so far…

In 2011 Sterling Pharma Solutions began the mission to replace their two unsupported Chromatography Data Systems (CDS) with a single solution. Chromeleon 7.1 CDS was selected for the short list and, after a rigorous assessment it was chosen and installation began in late 2011.

My involvement with Chromeleon CDS began in 2011 as a QC / Development analyst and quickly moved on to the reorganisation of the file naming convention. With the support of Thermo Fisher Scientific we began investigating how to best use the features of Chromeleon CDS with the aim of having the most efficient and compliant use possible of the CDS.

Ultimately I became Sterling’s Data Integrity and Chromeleon software specialist. I have participated in several regulatory audits including the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency UK (MHRA) and we are routinely audited by our customers. To date we have not received any major observations relating to Chromeleon CDS.

The table below details the timeline of some of our past, current, and planned future developments with the CDS. Next time I’ll talk more about our successes in controlling and driving down the use of manual integration at Sterling.

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About Sterling Pharma Solutions Ltd

Sterling Pharma Solutions is a contract research & manufacturer of active pharmaceutical ingredients (API). They provide small molecule API development and manufacturing services to the global pharmaceutical industry.