Articles tagged with “fda-21-cfr-part-11”

Learn the 5-stage eQMS maturity model for Biotech & MedTech startups. This framework guides QMS implementation for FDA and ISO 13485 compliance and scalability.

Evaluate top 10 accounting/ERP solutions for pharmaceutical companies. Learn about features like regulatory compliance, batch tracking, and quality control systems.

Learn about regulatory compliance software in pharmaceuticals, covering GMP, GLP, GCP, FDA 21 CFR Part 11, and EU Annex 11 standards for data integrity.

Evaluate LMS platforms for life sciences. Understand key compliance requirements: FDA 21 CFR Part 11, GxP, electronic records, and audit trails for validated training.

Compares NetSuite and SAP ERP systems' technical capabilities and regulatory compliance features for pharmaceutical and life sciences companies.

This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications. Updated for 2025-2026 with FDA CSA guidance, EU Annex 11 revision, and ISPE AI Guide.

How biotech and pharma companies use NetSuite for compliance: FDA 21 CFR Part 11, GxP, HIPAA, SOX, audit trails, e-signatures, and reporting best practices.