FT-IR Instrument Data Integrity Risk Assessment

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.

Industry

Pharmaceuticals

Area of Expertise

Data Integrity Management

Duration

4 weeks

Services Provided

Development of a comprehensive Data Integrity Risk Assessment Report with customized recommendations

Impact

Our client is able to improve the data integrity of their FT-IR instrument

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.

#CSA #CSV #LabAutomation

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