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.