Blogs & Articles

Is it mandatory to classify UAT records as raw data in pharma and biotech? Discover why executed UAT evidence may not be reconstructible and why raw data–like controls improve validation traceability and inspection readiness.

Computerized systems are central to GMP compliance in Life Sciences. This article explores the role of IT under GMP, regulatory expectations for system validation, and how effective alignment between Quality Assurance (QA) and Information Technology (IT) ensures compliant, reliable, and audit-ready operations.

ERP implementation is a strategic business transformation that aligns people, processes, and technology to drive efficiency and growth. Success depends on clear planning, strong governance, risk management, user adoption, and structured methodologies. By focusing on data readiness, change management, and continuous optimization, organizations can reduce failure rates and maximize long-term ERP value.

Successful ERP implementation requires clear objectives, well-defined processes, and a precise understanding of organizational needs. By building an expert project team, involving stakeholders, ensuring end-user training, and applying strong change management, companies can reduce risks, avoid costly failures, and maximize the operational value of their ERP system.

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.

Selecting GxP software isn’t just about features—it’s about trust, compliance, and risk. This practical framework helps life sciences organizations evaluate supplier quality, system risk, and validation needs using a structured, risk-based approach to ensure regulatory alignment and business continuity

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.