Articles tagged with “pharmaceutical-labeling”

Using GenAI to Draft Local Label Deviations in Pharma

Explore how GenAI helps manage pharmaceutical labeling. Learn to draft local label deviations from a CCDS and understand AI's role in regulatory compliance.

50 min read

11/24/2025

generative ai pharmaceutical labeling local label deviation veeva vault rim ccds regulatory affairs life sciences regulatory compliance

Veeva Label Concept Tracking: A Guide to Replacing Spreadsheets

Learn how Veeva's Label Concept Tracking in Vault RIM automates pharmaceutical labeling, manages local deviations, and replaces error-prone country tracker spre

30 min read

11/24/2025

veeva vault rim label concept tracking pharmaceutical labeling ccds management labeling compliance deviation management country tracker spreadsheet regulatory affairs

Veeva RIM for Labeling: A Guide to 5 Automated Workflows

Learn how Veeva RIM automates end-to-end pharmaceutical labeling. This guide explains 5 core workflows for label change management and regulatory compliance.

45 min read

11/24/2025

veeva vault rim pharmaceutical labeling labeling workflows end-to-end tracking label change management regulatory compliance life sciences ccds

Pharma Labeling Operations: A 6-Month Pre-Approval Checklist

Get a 6-month checklist for pharmaceutical labeling operations. This guide covers key steps for regulatory approval, FDA/GMP compliance, and avoiding costly del

35 min read

11/23/2025

labeling operations pharmaceutical labeling regulatory approval fda labeling requirements gmp product launch checklist serialization 21 cfr 201.56

Structured Product Labeling (SPL): A Guide to Data Integrity

Learn why Structured Product Labeling (SPL) is replacing PDF for pharma labeling. This guide explains the FDA mandate, XML standards, and how SPL ensures data i

30 min read

11/23/2025

structured product labeling spl data integrity pharmaceutical labeling regulatory affairs fda regulations hl7 alcoa+

e-Labeling & eIFU: Which Countries Accept QR Codes (2025)

This comprehensive 2025 guide details e-labeling (e-IFU) regulations worldwide. See our country-by-country analysis of QR code acceptance for medical devices &

35 min read

11/23/2025

e-labeling eifu qr codes medical device labeling regulatory compliance instructions for use pharmaceutical labeling eu mdr fda regulations

HL7 FHIR for Labeling: A Guide to the XML & SPL Transition

A comprehensive guide to transitioning from XML-based SPL to HL7 FHIR for e-labeling. Learn the key benefits, regulatory requirements, and steps for team readin

40 min read

11/22/2025

hl7 fhir e-labeling pharmaceutical labeling healthcare interoperability regulatory compliance data standards

Pharma Safety Labeling Updates: A 90-Day Cascade Model

Explore a structured cascade model for rolling out pharma safety labeling updates to global affiliates, ensuring regulatory compliance and sub-90-day implementa

25 min read

11/22/2025

pharmaceutical labeling pharmacovigilance regulatory affairs drug safety cascade communication company core data sheet global affiliate management

CCDS vs. Local Labels: Managing Global Labeling Deviations

Learn the difference between a Company Core Data Sheet (CCDS) and local labels. Explore strategies for managing global labeling deviations for regulatory compli

45 min read

11/22/2025

ccds global labeling labeling deviations pharmaceutical labeling local labels regulatory affairs structured authoring label harmonization