
Evaluate LMS platforms for life sciences. Understand key compliance requirements: FDA 21 CFR Part 11, GxP, electronic records, and audit trails for validated training.
Evaluate LMS platforms for life sciences. Understand key compliance requirements: FDA 21 CFR Part 11, GxP, electronic records, and audit trails for validated training.
This article outlines key parameters for a comprehensive report on GxP-compliant CMMS software, covering scope, features, standards, and vendors.
Learn to build a pharmaceutical manufacturing plant from concept through commissioning. This guide covers planning, regulatory compliance, design, equipment, quality, validation, and approval.
A detailed comparison of key compliance frameworks in pharmaceutical IT, including FDA 21 CFR Part 11, GDPR, HIPAA, and GxP, with implementation strategies and best practices.
A comprehensive guide to regulatory requirements and best practices for implementing compliant Randomization and Trial Supply Management (RTSM) systems in clinical trials, covering FDA, EMA, and global standards.