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Case Study Of 21 CFR Part 11

Decent Essays
Business Case
The client is a US-based multinational medical device, pharmaceutical, and consumer packaged goods manufacturer, founded in 1886. Counting on its 250 subsidiary companies with operations in 60 countries, the company leverages 130 years’ of expertise to bring innovative ideas, products, and services to advance the health and well-being of people across the globe.
In this case, the client identified lapses in data accuracy and consistency while capturing electronic records from various lab instruments used by its subsidiary companies. Additionally, some corrective and preventive actions were listed, which needed greater attention to avoid non-compliance with 21 CFR Part 11.
The scope of the service was extensive and demanded real-time monitoring of electronic records, audit trails, and necessity of monitoring compliance to enable 21 CFR Part 11.
Challenges
The multiple GMP-compliant labs located in several operating groups of the client were unable to ensure data integrity across all their lab systems due to discrepancies in different lab instruments. The instruments like Spectrometer, Titrator, Microscopes, UV Vis had their own way of capturing electronic records and there was no control over data usage. In consequence, there were huge gaps in meeting the regulatory compliance needs.
In addition,
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