Articles tagged with “gxp-compliance”

Learn about clinical trial vendor management and how CROs ensure oversight of labs, logistics, and translation services per ICH GCP and regulatory standards.

Explore how AI impacts Good Documentation Practice (GDocP) and ALCOA+ principles in life sciences. Learn about efficiency gains, data integrity risks, and new r

An in-depth analysis of pharmaceutical compliance software for GxP and QMS. Learn key features for 21 CFR Part 11 and compare top vendors like Veeva & MasterCon

Explore Veeva Vault alternatives like MasterControl & TrackWise. Our feature matrix for life sciences eQMS analyzes GxP readiness and 21 CFR Part 11 compliance.

Learn key principles for custom pharmaceutical software app design. This guide covers GxP compliance, 21 CFR Part 11, development methodologies, and tech like A

Learn to build a compliant ETL pipeline from Veeva Vault to an Amazon S3 data lake. This guide covers data extraction APIs, architecture, AWS tools, and GxP nee

Learn about Veeva's support SLA structure for life sciences. This guide explains support tiers, defines P1-P4 severity levels, and covers response time commitme

A detailed 2025 analysis of the GxP managed services market for pharma & life sciences. Learn about trends, regulatory drivers, and GxP compliance challenges.

Explore the 2024 Veeva application support provider landscape. This analysis covers key players, market size, and managed services for Veeva Vault and CRM.

Learn about Veeva Basics, a pre-configured suite of GxP software for emerging biotechs. This guide analyzes its features, modules, and implementation model.

Get a detailed playbook for post-merger IT integration in pharma. Learn key strategies for consolidating Veeva, SAP, and clinical data systems post-M&A.

Learn about Dassault Systèmes' QUMAS EDMS for life sciences. This guide covers its features, history, and use cases for GxP and 21 CFR Part 11 compliance.

Compare Veeva vs Salesforce for life sciences CRM. This analysis covers features, GxP compliance, and the strategic shift to Veeva Vault vs Salesforce Life Scie

An educational guide to Veeva Vault certification. Learn about training paths for Business & System Administrators, exam costs, maintenance fees, and career ROI

Learn the key updates in ISPE GAMP 5 Second Edition. Our guide covers the new focus on critical thinking, agile validation, cloud services, and CSA for GxP syst

A comprehensive guide to Veeva Vault's 2025 platform updates. Learn about key features in 25R1, 25R2, & 25R3, including Action Triggers, Process Monitor & Veeva

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

A comprehensive guide to implementing and optimizing NetSuite ERP for pharmaceutical companies, covering supply chain management, manufacturing operations, quality control, regulatory compliance, and integration with specialized pharma systems.