Pharmaceutical Laboratory Information Management System (LIMS) Audit Checklist
A comprehensive checklist for auditing pharmaceutical Laboratory Information Management Systems (LIMS), covering data integrity, system validation, access controls, and electronic records management to ensure compliance with regulatory requirements and maintain data reliability.
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About This Checklist
The Pharmaceutical Laboratory Information Management System (LIMS) Audit Checklist is a crucial tool for ensuring the integrity, security, and compliance of laboratory data management processes in pharmaceutical companies. This comprehensive checklist addresses key aspects of LIMS implementation and operation, including data integrity, system validation, user access controls, audit trails, and electronic records management. By systematically evaluating LIMS processes, pharmaceutical companies can maintain compliance with regulatory requirements such as 21 CFR Part 11, enhance the reliability of laboratory data, and streamline laboratory operations. This checklist helps identify potential vulnerabilities in data management practices, ultimately contributing to the overall quality and trustworthiness of pharmaceutical research and quality control processes.
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