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.

Pharmaceutical Laboratory Information Management System (LIMS) Audit Checklist
by: audit-now
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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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Industry

Pharmaceuticals

Standard

21 CFR Part 11 (Electronic Records; Electronic Signatures) and EU GMP Annex 11 (Computerised Systems)

Workspaces

Pharmaceutical Laboratories and IT Departments

Occupations

IT Manager
Quality Assurance Specialist
Laboratory Manager
LIMS Administrator
Data Integrity Auditor

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