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Laboratory Informatics Experts

Empower 3 Enhancement and Validation

Situation

BiopharmaceuticalAt a global consumer healthcare company’s Ontario site, the organization was seeking to increase their laboratory efficiency and harmonize the company’s chromatography methods globally, where feasible. The site was utilizing a validated version of Empower 3, however, standardized processing and report methods across groups had not been established, requiring each group to recreate these items, as needed. This, of course, negatively impacted the efficieny of the scientists and allowed variations in the processing and reporting methods. This, in turn, affected product testing consistency and quality across both the site and the enterprise. the company, therefore, decided to enhace and harmonize their Empower 3 CDS at the Ontario facility by developing standardized processing and reporting methods. Once established and validated these methods could then be proliferated to all sites and labs.

In order to standardize and automate the processes, enhance,ents and configuration changes would have to be developed, implemented and tested. In fact, in a regulated environment such as this, the changes and new functionality would require an incremental validation of the Empower 3 CDS be conducted. CSols, Inc. was engaged to document, develop, impleent, and validate the new Empower 2 processing and reporting methods. Csols was chosen for this project because of our expertise with Empower 3, our domain knowledge, hands on experience (industry, type of lab, etc.), our regulatory expertise and our track record of successfully delivering other informatics projects for this client.

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