Articles tagged with “fda-regulations”

An analysis of how DocuSign is used for electronic signatures in pharma and life sciences. Learn how it can meet FDA 21 CFR Part 11 compliance with its modules.

A detailed guide for IT on 21 CFR Part 11. Learn the FDA's rules for electronic records & signatures, including system validation, audit trails, & data integrit

An analysis of the 2025 surge in new drug manufacturing plants from Eli Lilly, AstraZeneca & more. Learn about the key drivers: supply chain & geopolitics.

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

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.

Explore Good Manufacturing Practice (GMP) in pharma. Learn its principles, global regulations, implementation, and compliance challenges for quality assurance.

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

In-depth guide to U.S. pharmaceutical marketing regulations: FDA, FTC, Sunshine Act, anti-kickback, compliance, and IT obligations for pharma companies.

An analysis of how artificial intelligence is transforming regulatory affairs in pharmaceuticals, from submission preparation to compliance monitoring and regulatory intelligence.

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 detailed exploration of Non-Personal Promotion strategies in pharmaceutical marketing, covering best practices, compliance requirements, and tools for effective HCP engagement without face-to-face interaction.