An analysis of top ERP systems for the pharmaceutical sector, evaluated on regulatory compliance (21 CFR Part 11), batch traceability, and serialization.

This article explains the core functions of LIMS for sample management, data integrity, and regulatory compliance, and provides a comparative analysis of top systems.

An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies and data integrity measures.

Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance, and controls for data integrity and audit-ready systems.

Explore US pharmaceutical automation compliance, covering FDA regulations like cGMP & 21 CFR Part 11, Pharma 4.0 trends, challenges, and best practices.

Learn about the 2025 job market for Computer System Validation (CSV) professionals. Understand CSV's critical role in regulated industries for data integrity and patient safety.

Learn how NetSuite ERP modules support U.S. pharmaceutical manufacturing labs, covering GMP, FDA (21 CFR Part 11) compliance, and integrations for quality and production.

Learn about 21 CFR Part 11, the FDA regulation for electronic records and signatures. This article covers its history, purpose, and significance in the pharmaceutical industry.

Learn what Computer System Validation (CSV) is, its crucial role in pharmaceutical and biotech compliance, ensuring data integrity and regulatory adherence for patient safety.

A comprehensive guide to building and scaling Veeva Vault and CRM data pipelines for terabyte-scale datasets in the pharmaceutical industry, with a focus on compliance and performance.

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.

Comprehensive overview of Oracle's role in the pharmaceutical industry, covering their Health Sciences solutions, cloud infrastructure, compliance features, and case studies of successful implementations at major pharma companies.