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Good Documentation Practices (GDocP) ensure accuracy, traceability, and compliance across GxP environments. By standardizing how data is recorded and managed, GDocP protects data integrity, supports quality decisions, and reduces regulatory risks. Strong documentation practices remain essential for safe, compliant, and consistent Life Sciences operations.

Software validation is essential in life sciences to ensure compliance, data integrity, and patient safety. Guided by GAMP 5 and FDA CSA, modern validation uses risk-based methods to verify that systems like SaMD, LIMS, QMS, and MES perform reliably. By applying critical thinking, strong supplier oversight, and lifecycle monitoring, organizations can meet FDA and EU requirements while improving quality and operational efficiency

ERP systems are essential for Life Sciences companies seeking compliance and efficiency. A Life Sciences ERP must ensure GxP validation, integrate Quality Management (QMS), enable full traceability, and support audit readiness. Scalable, modular, and validation-ready ERPs enhance data integrity, regulatory compliance, and patient safety. Learn how to choose the right ERP for your Life Sciences organization with InnovX.

Stay updated with the latest in the life sciences industry through these top 10 trusted information sources. From regulatory updates by the FDA and EMA to expert insights from The Scientist and Life Science Leader, this curated list helps professionals in biotech, pharma, and clinical research stay compliant, informed, and competitive. Perfect for life sciences experts in North America and Europe seeking reliable, free, and up-to-date content.

Rethink GMP: Cut complexity, not quality. Focus on efficient systems that truly improve product quality and patient safety.

Explores the validation scope outlined in the FDA's guidance, reviews key recommendations, and examines its potential impact.

As we approach 2025, QA and validation teams in life sciences must navigate emerging challenges and opportunities to remain compliant.

Life sciences focus on cybersecurity, AI, and IT alignment in 2025. QA experts lead compliance, innovation, and operational success.

10 essential questions to ask before choosing a GxP system to ensure compliance, reliability, and scalability in life sciences.