Articles tagged with “pharma-compliance”

DocuSign in Pharma: A Guide to 21 CFR Part 11 Compliance

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.

45 min read

10/23/2025

docusign 21 cfr part 11 pharma compliance electronic signatures life sciences fda regulations gxp system validation annex 11

GAMP 4 vs GAMP 5: Key Differences & Migration Guide

Learn the key differences between GAMP 4 and GAMP 5. This guide for pharma IT covers the shift to risk-based validation and provides a clear migration path.

35 min read

10/15/2025

gamp 5 gamp 4 vs gamp 5 risk-based validation pharma compliance ispe gxp guidelines data integrity

Pharmaceutical Marketing Regulations: A Comprehensive Overview

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

65 min read

5/15/2025

pharma compliance FDA regulations Sunshine Act anti-kickback marketing IT pharma marketing regulatory affairs

KOL Tiering in the US Pharmaceutical Industry: Definition, Criteria, and Best Practices

A comprehensive guide to Key Opinion Leader (KOL) tiering in pharmaceutical marketing, covering definition, strategic importance, tiering criteria, engagement strategies, and compliance considerations for U.S. pharma companies.

90 min read

4/14/2025

kol-tiering key-opinion-leaders pharma-marketing medical-affairs thought-leaders physician-engagement healthcare-influencers pharma-compliance medical-education