# GxP * **Definition:** Abbreviation for 'Good Practice' quality guidelines and regulations ensuring product safety and traceability throughout various stages of development and distribution, particularly in life sciences projects. * **Taxonomy:** Healthcare Topics / GxP ## News * Selected news on the topic of **GxP**, for healthcare technology leaders * 894 news items are in the system for this topic * Posts have been filtered for tech and healthcare-related keywords | Date | Title | Source | | --- | --- | --- | | 4/15/2025 | [**Sware ce Partner to Bring AI-Driven Technology to the Life Sciences Cloud**](https://hitconsultant.net/2025/04/15/sware-salesforce-partner-to-bring-ai-driven-technology-to-the-life-sciences-cloud/) | [[HIT Consultant]] | | 4/15/2025 | [**Sware Selected to Validate AI-Driven GxP Compliance for Salesforce Life Sciences Cloud**](https://finance.yahoo.com/news/sware-selected-validate-ai-driven-130000824.html) | [[Yahoo Finance]] | | 3/31/2025 | [**GXP-Storage Establishes Expert Advisory Board to Drive Innovation in Data-Driven Managed Biostorage Solutions**](https://www.morningstar.com/news/business-wire/20250401219217/gxp-storage-establishes-expert-advisory-board-to-drive-innovation-in-data-driven-managed-biostorage-solutions) | [[Morningstar]] | | 3/17/2025 | [**NGS is changing GxP compliance. Will you adapt?**](https://www.biopharmadive.com/spons/ngs-is-changing-gxp-compliance-will-you-adapt/741710/) | [[BioPharma Dive]] | | 2/24/2025 | [**latest MHRA data integrity guide and EMA TMF guideline (ONLINE EVENT - Yahoo Finance**](https://finance.yahoo.com/news/data-integrity-document-management-training-094400661.html) | [[Yahoo Finance]] | | 12/16/2024 | [**GXP-Storage Secures Strategic Growth Investment from Whistler Capital Partners ... - Business Wire**](https://www.businesswire.com/news/home/20241216573955/en/GXP-Storage-Secures-Strategic-Growth-Investment-from-Whistler-Capital-Partners-to-Advance-Biorepository-and-Regulated-Material-Management-Services) | [[Business Wire]] | | 12/16/2024 | [**GXP-Storage Secures Strategic Growth Investment from Whistler Capital Partners to Advance Biorepository and Regulated Material Management Services**](http://www.businesswire.com/news/home/20241216573955/en/GXP-Storage-Secures-Strategic-Growth-Investment-from-Whistler-Capital-Partners-to-Advance-Biorepository-and-Regulated-Material-Management-Services/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 12/14/2024 | [**Bushu Pharma Applauded by Frost & Sullivan for Offering Customer Value in APAC CDMO Industry Through Consistent Quality Assurance, On-time Delivery, Sustainability, and Competitive Costs**](https://www.prnewswire.com/news-releases/bushu-pharma-applauded-by-frost--sullivan-for-offering-customer-value-in-apac-cdmo-industry-through-consistent-quality-assurance-on-time-delivery-sustainability-and-competitive-costs-302331897.html) | [[PR Newswire]] | | 12/2/2024 | [**All About FDA Data Integrity by Design Course: What is Next for the Modernization ... - Business Wire**](https://www.businesswire.com/news/home/20241202190741/en/All-About-FDA-Data-Integrity-by-Design-Course-What-is-Next-for-the-Modernization-of-the-Processes-Involved-in-Compliance-for-FDA-regulated-Systems-ONLINE-EVENT-December-9-10-2024ON-DEMAND---ResearchAndMarkets.com) | [[Business Wire]] | | 11/28/2024 | [**21 CFR Part 11, SaaS/Cloud, EU GDPR Virtual Course: Reducing Costs for Compliance ...**](https://www.marketwatch.com/press-release/21-cfr-part-11-saas-cloud-eu-gdpr-virtual-course-reducing-costs-for-compliance-with-data-integrity-line-event-january-30-31-2025-or-on-demand-researchandmarkets-com-47f29fff) | [[MarketWatch]] | | 11/19/2024 | [**Clovertex Awarded AWS Life Sciences Competency, Solidifying Leadership in Cloud-Based ...**](https://finance.yahoo.com/news/clovertex-awarded-aws-life-sciences-135400458.html) | [[Yahoo Finance]] | | 11/19/2024 | [**Clovertex Awarded AWS Life Sciences Competency, Solidifying Leadership in Cloud-Based ...**](https://www.prnewswire.com/news-releases/clovertex-awarded-aws-life-sciences-competency-solidifying-leadership-in-cloud-based-solutions-for-life-sciences-302309650.html) | [[PR Newswire]] | | 11/18/2024 | [**Data Integrity and Document Management Training Course: Discussion of the Latest MHRA Data Integrity and EMA TMF Guidelines (ONLINE EVENT: December 6, 2024/ON-DEMAND) - ResearchAndMarkets.com**](http://www.businesswire.com/news/home/20241118924195/en/Data-Integrity-and-Document-Management-Training-Course-Discussion-of-the-Latest-MHRA-Data-Integrity-and-EMA-TMF-Guidelines-ONLINE-EVENT-December-6-2024ON-DEMAND---ResearchAndMarkets.com/?feedref=JjAwJuNHiystnCoBq_hl-Q-tiwWZwkcswR1UZtV7eGe24xL9TZOyQUMS3J72mJlQ7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LOzmn6JePCpHPCiYGaEx4DL1Rq8pNwkf3AarimpDzQGuQ==) | [[Business Wire]] | | 11/12/2024 | [**Leading Molecular Diagnostics Company BillionToOne Announces Three Executive Appointments Amid Rapid Growth**](https://www.prnewswire.com/news-releases/leading-molecular-diagnostics-company-billiontoone-announces-three-executive-appointments-amid-rapid-growth-302302024.html) | [[PR Newswire]] | | 10/31/2024 | [**Loftware and Signant Health Announce Availability of Integrated Clinical Supplies Labeling Solution**](https://www.prnewswire.com/news-releases/loftware-and-signant-health-announce-availability-of-integrated-clinical-supplies-labeling-solution-302292752.html) | [[PR Newswire]] | | 9/3/2024 | [**Ganymede Bio Launches Industry-First GxP-Native Developer Platform and Data Infrastructure for Wet Lab Data**](http://www.businesswire.com/news/home/20240903181259/en/Ganymede-Bio-Launches-Industry-First-GxP-Native-Developer-Platform-and-Data-Infrastructure-for-Wet-Lab-Data/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 9/3/2024 | [**Ganymede Bio Launches Industry-First GxP-Native Developer Platform and Data Infrastructure for Wet Lab Data**](http://www.businesswire.com/news/home/20240903181259/en/Ganymede-Bio-Launches-Industry-First-GxP-Native-Developer-Platform-and-Data-Infrastructure-for-Wet-Lab-Data/?feedref=JjAwJuNHiystnCoBq_hl-Q-tiwWZwkcswR1UZtV7eGe24xL9TZOyQUMS3J72mJlQ7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LOzmn6JePCpHPCiYGaEx4DL1Rq8pNwkf3AarimpDzQGuQ==) | [[Business Wire]] | | 8/13/2024 | [**Generative AI Impact in Life Sciences and Healthcare - HCLTech**](https://www.hcltech.com/life-sciences-healthcare/generative-ai-impact) | hcltech.com | | 7/23/2024 | [**ValGenesis and FrontWell Solutions Announce Strategic Alliance**](http://www.businesswire.com/news/home/20240723860092/en/ValGenesis-and-FrontWell-Solutions-Announce-Strategic-Alliance/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 7/22/2024 | [**MasterControl Makes GxPAssist AI Generally Available to Streamline Life Science Processes**](https://www.prnewswire.com/news-releases/mastercontrol-makes-gxpassist-ai-generally-available-to-streamline-life-science-processes-302200389.html) | [[PR Newswire]] | | 7/22/2024 | [**MasterControl Makes GxPAssist AI Generally Available to Streamline Life Science Processes**](https://www.morningstar.com/news/pr-newswire/20240722la64183/mastercontrol-makes-gxpassist-ai-generally-available-to-streamline-life-science-processes) | [[Morningstar]] | | 7/22/2024 | [**MasterControl launches GxPAssist AI for life science quality and manufacturing**](https://www.medicaldesignandoutsourcing.com/mastercontrol-launches-gxpassist-ai-for-life-science-quality-and-manufacturing/) | medicaldesignandoutsourcing.com | | 7/19/2024 | [**Leading trustworthy AI in life sciences - Capgemini Invent**](https://www.capgemini.com/insights/research-library/leading-trustworthy-ai-in-life-sciences/) | capgemini.com | | 7/16/2024 | [**ValGenesis and Pharmasys in Strategic Partnership to Enhance Compliance in European ...**](https://finance.yahoo.com/news/valgenesis-pharmasys-strategic-partnership-enhance-130000163.html) | [[Yahoo Finance]] | | 6/20/2024 | [**Azzur Group Appoints Nick Mazzucca as Vice President of Sales and Marketing**](https://www.prnewswire.com/news-releases/azzur-group-appoints-nick-mazzucca-as-vice-president-of-sales-and-marketing-302178311.html) | [[PR Newswire]] | ## Topic Overview (Some LLM-derived content — please confirm with above primary sources) ### Key Players - **GXP-Storage**: A company specializing in compliant management of regulated materials, enhancing operational capabilities. - **Ganymede Bio**: Introduced the GxP Data Automation Platform (GDP) to support GxP software development lifecycle for lab data capture and automation. - **MasterControl**: Provider of GxP compliance solutions, recently launched GxPAssist AI, a suite of generative AI tools to enhance quality and manufacturing processes. - **PQE Group**: A consultancy firm that focuses on regulatory compliance and has established a new division for AI and data analysis to improve efficiency in GxP processes. - **Unicon Pharma**: A company that has partnered with Core Service Group to provide customized GxP project services for life sciences companies. - **Rephine**: A specialist in quality assurance and GxP compliance, launching an online portal for clients to access audits and management tools. - **SmartSense by Digi**: Achieved SOC 2 Type II certification, demonstrating commitment to data security and GxP environment standards. - **Genedata**: Leading enterprise software system for biopharmaceutical R&D, known for its Genedata Selector platform that automates quality control processes. - **Nippon Express Holdings, Inc.**: A logistics company that partnered with Controlant, Inc. to enhance real-time monitoring services for the pharmaceutical industry, ensuring compliance with GxP standards. - **Sapio Sciences**: A company that launched a new GMP LIMS solution to help laboratories comply with Good Manufacturing Practice and enhance compliance in manufacturing processes. - **Azzur Group**: Provides comprehensive GMP solutions and has appointed a new VP of Sales and Marketing to enhance its business development strategy. - **ProductLife Group (PLG)**: A consultancy that acquired HERAX Life Science to enhance capabilities in regulatory and digital transformation consulting. - **ValGenesis**: Innovator in digitized validation solutions, recognized for its VLMS platform used in GMP systems globally. - **Capgemini**: A consulting firm actively addressing regulatory challenges in AI for the life sciences sector. - **Thermo Fisher Scientific**: A leading provider of laboratory products and services, recently launched a new product for CAR-T cell therapies that complies with cGMP standards. - **Neuraxpharm**: A pharmaceutical company that adopted Veeva Vault QualityDocs and Training to improve quality processes and compliance. ### Partnerships and Collaborations - **ProductLife Group and HERAX Life Science**: This acquisition aims to accelerate drug development and streamline clinical trials in GxP regulated areas. - **Nippon Express and Controlant**: This partnership aims to enhance real-time monitoring services for the pharmaceutical industry, ensuring compliance with GxP standards. - **Unicon Pharma and Core Service Group**: This collaboration focuses on providing a comprehensive suite of customized GxP project services for life sciences companies. - **PQE Group and GenAIz**: Collaboration to enhance compliance and innovation in AI solutions for regulated industries. - **Capgemini and Clients**: Collaborating to develop a platform compliant with European AI legislation for life sciences. - **ValGenesis and Validator K.K.**: Partnering to enhance validation services in the Japanese life sciences sector. - **ValGenesis and Zamann Pharma Support**: Formed a strategic alliance to tackle quality assurance and compliance challenges in Europe. - **ValGenesis and FrontWell Solutions**: Strategic alliance to enhance digital validation solutions for life sciences companies. - **Charles River Laboratories and Gates Institute**: Collaborating to develop GMP-grade lentiviral vectors for CAR T-cell therapies. - **Sapio Sciences and Waters Corporation**: Co-marketing agreement to improve data integrity and streamline laboratory operations through LIMS integration. - **Loftware and Signant Health**: Integrated solution to automate clinical trial processes and improve efficiency in clinical supplies management. - **Ori Biotech and Fresenius Kabi**: Collaborating to integrate Ori's IRO platform with Fresenius Kabi's technologies to enhance efficiency in cell and gene therapy manufacturing. - **Cellares and IDMO Smart Factory**: Cellares is expanding its global network of smart factories to enhance cell therapy manufacturing. - **YolTech and KACTUS**: A partnership to commercialize YolCas12TM gene editing technology in Greater China. - **Agilent Technologies and BIOVECTRA**: Agilent announced an acquisition of BIOVECTRA to enhance its biopharma offerings and integrate advanced manufacturing capabilities. - **TetraScience and Microsoft**: This collaboration seeks to enhance the adoption of scientific AI across the biopharmaceutical value chain. ### Innovations, Trends, and Initiatives - **GXP-Guardian System**: A proprietary system for real-time inventory management and regulatory compliance being developed by GXP-Storage. - **GXP-Guardian system**: A proprietary system for regulated material management that GXP-Storage is developing with new investment. - **GxPAssist AI**: MasterControl's suite of AI tools including Exam Generator, Document Translator, and Document Summarizer aimed at improving training and compliance. - **AI in GxP Environments**: Modicus Prime's AI image processing platform for drug manufacturing aims to enhance quality control and reduce costs. - **GxPAssist AI Suite**: MasterControl's AI-powered Document Summarizer aims to improve document management processes in regulated industries. - **Data Integrity Training**: Courses focusing on data integrity and compliance with GxP standards are being offered to professionals in regulated industries. - **GMP LIMS Solution**: Sapio Sciences launched a GMP LIMS solution to automate quality control processes and enhance compliance in laboratories. - **Sapio GMP LIMS**: A no-code laboratory information management system that automates quality control processes and enhances compliance with regulatory standards. - **BioMap Consortium**: VGXI's participation aims to enhance U.S. biopharmaceutical manufacturing capabilities. - **GMP-compliant Production**: BrightPath's use of Cellistic's 3D bioreactor platform to ensure compliance in CAR-T cell therapy manufacturing. - **Pharma 4.0 Operating Model**: Focuses on integrating health regulations and industry best practices to enhance efficiency in FDA-regulated product development. - **Genedata Profiler 16.6**: An analytics platform that enhances data analysis capabilities for biopharmaceutical researchers, facilitating faster decision-making. - **Veeva Vault Implementation**: Neuraxpharm's adoption of Veeva's quality applications aims to improve oversight and inspection readiness. - **ResearchAndMarkets.com Training Course**: A new course focusing on aseptic processing principles and regulatory insights for pharmaceutical and biotech professionals. - **Rephine Connect Portal**: An online portal providing clients with access to audits and tools for CAPA management and audit tracking. - **Document Translator by MasterControl**: An AI-powered tool designed to translate critical procedural documents into multiple languages to ensure global compliance. - **Advanced Automation in Cell Therapy**: Cellares' use of interconnected software systems to auto-generate electronic batch records, reducing human error. - **Sustainable Solutions in Biopharmaceutical Manufacturing**: Avantor's biodegradable alternatives for gene therapy processes to reduce ecotoxicity. - **SaaS in Life Sciences**: Emergence of Service as Software (SaaS) is transforming pharmaceutical production, enabling automation and real-time data analytics. - **Generative AI in Healthcare**: Transforming drug discovery, clinical trials, and healthcare operations by analyzing large datasets and enhancing operational efficiency. ### Challenges and Concerns - **Training GxP Personnel**: There is a need for effective training programs that address data integrity and compliance to prevent regulatory breaches. - **Data Integrity**: A critical focus for health authorities, with increasing emphasis on ensuring data integrity in GxP audits to prevent regulatory violations. - **Regulatory Compliance**: The need for detailed regulatory guidance on AI documentation to ensure compliance with GxP standards. - **Contamination Risks in Manufacturing**: Efforts to minimize contamination risks in gene therapy processes through innovative product formulations. - **Out-of-Specifications (OOS)**: Challenges in managing OOS in medicinal products due to human error, laboratory issues, and supply chain challenges. - **Quality Assurance**: Life sciences companies face challenges in maintaining compliance and quality assurance amidst rapid technological advancements. - **Data Security in SaaS**: Life science companies face challenges related to data security, necessitating robust measures from SaaS providers. - **Data Integrity Scrutiny**: Regulatory inspections are increasingly scrutinizing document management and data integrity, emphasizing the need for training. - **Inspection Readiness**: Companies must build robust inspection readiness programs to align with updated regulatory guidelines and ensure compliance. - **AI Regulation**: Regulators are beginning to set expectations for AI solutions, requiring comprehensive documentation to ensure explainability and performance. - **Compliance Costs**: Organizations face challenges in reducing compliance costs associated with data integrity in regulated environments. - **Emerging Regulatory Challenges with AI**: As AI technologies are integrated into healthcare, organizations must prepare for new regulatory landscapes.