FT-IR Instrument Data Integrity Risk Assessment
Our Contract Lab Testing Client retained the services of the Brevitas team to provide them with support to assess the data integrity of their FT-IR instrument to ensure regulatory compliance with FDA, Health Canada, EU regulatory requirements and the industry’s best practices.
Business Challenge
Our client required the data integrity of their FT-IR instrument to be assessed. The project involved the development of a workflow diagram of the instrument, and a detailed assessment of the data integrity of the entire workflow to produce a comprehensive data integrity risk assessment report along with recommendations for the FT-IR instrument.
Our Approach
We visited our client’s site to understand their current process and procedures for the instrument. We developed a data flow diagram showcasing the workflow and data lifecycle from acquisition, to analysis, to storage and disposal. We conducted a DI risk assessment on this data flow and identified procedural and engineering controls to achieve DI compliance for this system. We also developed a data integrity risk assessment procedure and provided personnel training.
Results Achieved
From inception to completion, the Brevitas team contributed to our client’s success by delivering a comprehensive Data Integrity Risk Assessment Report of the FT-IR instrument with customized recommendations, a Data Integrity Risk Assessment procedure and personnel training.
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