Pharmaceutical Laboratory Information Management System (LIMS) Compliance Checklist

A comprehensive checklist for ensuring compliance of Laboratory Information Management Systems (LIMS) with FDA 21 CFR Part 11 in pharmaceutical quality control laboratories, covering system functionality, data integrity, and regulatory requirements.

Pharmaceutical Laboratory Information Management System (LIMS) Compliance Checklist
by: audit-now
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About This Checklist

The Pharmaceutical Laboratory Information Management System (LIMS) Compliance Checklist is an essential tool for ensuring that LIMS used in pharmaceutical quality control laboratories meet FDA 21 CFR Part 11 requirements. This comprehensive checklist guides pharmaceutical companies through the complex process of implementing, validating, and maintaining compliant LIMS. By addressing key aspects such as data integrity, system security, audit trails, and integration with laboratory instruments, this checklist helps maintain the highest standards of laboratory operations, enhances the reliability of analytical results, and ensures regulatory compliance in pharmaceutical quality control processes.

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Industry

Pharmaceuticals

Standard

FDA 21 CFR Part 11

Workspaces

Pharmaceutical Quality Control Laboratories

Occupations

Laboratory Manager
Quality Control Analyst
LIMS Administrator
Compliance Specialist
Analytical Chemist

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