![\"\"](\"https:\/\/elifesciences.co\/wp-content\/uploads\/2025\/03\/sLifeSciences-01-white.svg\")
\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t![\"What](\"https:\/\/elifesciences.co\/wp-content\/uploads\/2026\/09\/1200x627-2-1000x523.png\")
<\/div><\/a>\n\t\t\t\t\n\t\t\t\n\t\t\t\tThe Next Stage of GxP Validation: Five Takeaways from the ISPE Nordic-Baltic Validation Summit\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t\n\t\t\teLife Sciences highlights five practical insights from the ISPE Nordic-Baltic Validation Summit in Vilnius on the future of GxP validation.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\n\t\t\tSeptember 23, 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t\n\t\t\t\n\t\t\t\t![\"\"](\"https:\/\/elifesciences.co\/wp-content\/uploads\/2026\/08\/GxP-1-1000x666.png\")
<\/div><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\tGxP in Life Sciences: Core Areas, Requirements, and Goals\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t\n\t\t\tGxP is the umbrella term for the regulations governing manufacturing, testing, and distribution across pharma, biotech, and medtech. Understanding what GxP compliance actually requires is the starting point for any organization operating in a regulated environment.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\n\t\t\tAugust 12, 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t\n\t\t\t\n\t\t\t\t![\"\"](\"https:\/\/elifesciences.co\/wp-content\/uploads\/2026\/08\/digital-transformation-gxp-1-1000x666.png\")
<\/div><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\tDigital Transformation in GxP-Regulated Life Sciences\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t\n\t\t\tDigital transformation in a GxP environment is not just another IT rollout \u2014 it’s a controlled shift in how quality, validation, and data are managed. Get it wrong, and you risk regulatory non-compliance. Here’s how eLife Sciences approaches it the right way.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\n\t\t\tAugust 12, 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t\n\t\t\t\n\t\t\t\t![\"\"](\"https:\/\/elifesciences.co\/wp-content\/uploads\/2026\/08\/Annex-22-1-1000x666.png\")
<\/div><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\tEU GMP Annex 22: The New AI Framework for Life Sciences\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t\n\t\t\tAnnex 22 is the first EU GMP standard designed specifically to govern artificial intelligence and machine learning within regulated pharmaceutical environments. Once finalized, it will apply directly to manufacturers of active substances and medicinal products operating under GxP.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\n\t\t\tAugust 11, 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t\n\t\t\t\n\t\t\t\t![\"\"](\"https:\/\/elifesciences.co\/wp-content\/uploads\/2026\/08\/Annex-11-1-1000x666.png\")
<\/div><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\tEU GMP Annex 11: Regulating Computerized Systems in the Pharmaceutical Industry\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t\n\t\t\tEU Annex 11 is the cornerstone framework regulating the use of computerized systems in the European pharmaceutical industry. It sets strict expectations for software validation, data integrity, and system security. For any life sciences organization using digital tools in GxP environments, understanding and implementing these rules is non-negotiable.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\n\t\t\tAugust 11, 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t\n\t\t\t\n\t\t\t\t![\"\"](\"https:\/\/elifesciences.co\/wp-content\/uploads\/2026\/08\/CQV-1-1000x666.png\")
<\/div><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\tCQV: How to Plan Commissioning, Qualification, and Validation\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t\n\t\t\tCQV stands for Commissioning, Qualification and Validation \u2014 the structured process that confirms facilities, systems, and equipment in regulated environments are ready to operate exactly as designed, before they go live. For life sciences manufacturers, this isn’t a single hand-off inspection; it’s a documented, risk-based pathway that reduces failure risk and builds the evidence base regulators expect to see. Done well, CQV turns a chaotic start-up into a predictable, audit-ready launch.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t
eLife Sciences highlights five practical insights from the ISPE Nordic-Baltic Validation Summit in Vilnius on the future of GxP validation.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t GxP is the umbrella term for the regulations governing manufacturing, testing, and distribution across pharma, biotech, and medtech. Understanding what GxP compliance actually requires is the starting point for any organization operating in a regulated environment.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t Digital transformation in a GxP environment is not just another IT rollout \u2014 it’s a controlled shift in how quality, validation, and data are managed. Get it wrong, and you risk regulatory non-compliance. Here’s how eLife Sciences approaches it the right way.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t Annex 22 is the first EU GMP standard designed specifically to govern artificial intelligence and machine learning within regulated pharmaceutical environments. Once finalized, it will apply directly to manufacturers of active substances and medicinal products operating under GxP.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t EU Annex 11 is the cornerstone framework regulating the use of computerized systems in the European pharmaceutical industry. It sets strict expectations for software validation, data integrity, and system security. For any life sciences organization using digital tools in GxP environments, understanding and implementing these rules is non-negotiable.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t CQV stands for Commissioning, Qualification and Validation \u2014 the structured process that confirms facilities, systems, and equipment in regulated environments are ready to operate exactly as designed, before they go live. For life sciences manufacturers, this isn’t a single hand-off inspection; it’s a documented, risk-based pathway that reduces failure risk and builds the evidence base regulators expect to see. Done well, CQV turns a chaotic start-up into a predictable, audit-ready launch.<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead more \u2192\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div><\/a>\n\t\t\t\t\n\t\t\t\n\t\t\t\tGxP in Life Sciences: Core Areas, Requirements, and Goals\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
<\/div><\/a>\n\t\t\t\t\n\t\t\t\n\t\t\t\tDigital Transformation in GxP-Regulated Life Sciences\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
<\/div><\/a>\n\t\t\t\t\n\t\t\t\n\t\t\t\tEU GMP Annex 22: The New AI Framework for Life Sciences\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
<\/div><\/a>\n\t\t\t\t\n\t\t\t\n\t\t\t\tEU GMP Annex 11: Regulating Computerized Systems in the Pharmaceutical Industry\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
<\/div><\/a>\n\t\t\t\t\n\t\t\t\n\t\t\t\tCQV: How to Plan Commissioning, Qualification, and Validation\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t