# GxP Readiness on 3DEXPERIENCE **Enabling Compliance in Regulated Industries** GxP Readiness by Design For process-based scientific industries that operate in GxP spaces (those which follow “good practice” guidelines and regulations) a platform that is GxP-ready by design is essential for regulatory compliance. With built-in features like electronic signatures, the **3D**EXPERIENCE platform supports regulatory standards like 21 CFR Part 11 and EU Annex 11, and enables customers to demonstrate compliance through Computerized System Validation (CSV). (3DEXPERIENCE GxP Validation Highlight)A Validation-Ready Platform The [**3D**EXPERIENCE platform](/3dexperience-platform "The 3DEXPERIENCE platform") is the only end-to-end solution designed for process industries, with seamless deployment capabilities on the cloud in GxP spaces, as a SaaS offering. The **3D**EXPERIENCE platform enables organizations to streamline operations, enhance compliance, and drive innovation, all within a single, unified environment. [3DEXPERIENCE GxP Compliance Higlight 1](/media/19865) (3DEXPERIENCE GxP Validation Highlight)Electronic Records and Signatures In GxP environments, electronic records and signatures are essential for GxP compliance by providing a secure, reliable, and auditable way to document critical processes and data. They also support audit readiness by maintaining a complete history of changes to protect data integrity. For insight into how our software solutions help enable customer regulatory compliance with the requirements of the US Food and Drug Administration (FDA) 21 CFR Part 11 and the European Unions’ EU Annex 11, download our position paper: [3DEXPERIENCE GxP Compliance Highlight 2](/media/19866) [Download position paper](https://www.3ds.com/assets/invest/2024-03/3ds-21-cfr-part11-eu-annex-11-position-paper.pdf) (3DEXPERIENCE GxP Validation Highlight)Accelerating GxP Validation Through Best Practices Dassault Systèmes performs risk-based assessments and prepares validation documents aligned with GAMP5 guidelines to facilitate our customers' efficient validation efforts of their SaaS production environment. The **3D**EXPERIENCE platform enhances validation readiness through an optional, dedicated cloud staging environment for pre-production release assessment, supported by an Installation Verification Report that streamlines customer Installation Qualification (IQ) processes. To learn more, download the **Risk-Based Software Quality Assurance** white paper: [3DEXPERIENCE GxP Readiness](/media/19896) [Download the white paper](https://media.3ds.com/support/white-papers/trust/3DS-2024-LSH-RBA-Whitepaper.pdf) (3DEXPERIENCE GxP Validation Highlight)A Legacy of GxP Compliance Leadership Dassault Systèmes has a long-standing commitment to providing GxP-ready solutions that empower laboratories, quality management systems, and manufacturing processes. We help transform workflows in regulated industries and have been instrumental in supporting scientists and industry professionals in achieving their compliance goals. At Dassault Systèmes, we put security, privacy and quality at the heart of our **3D**EXPERIENCE platform operations. Visit the **3D**EXEPERIENCE Trust Center to learn more. [3DS Trust Center Highlight](/media/19864) [Visit 3DS Trust Center](/trust-center) (3DEXPERIENCE GxP Validation Highlight)Join the Next Generation of Compliance The **3D**EXPERIENCE platform represents a major leap forward in compliance technology, offering unparalleled capabilities for those committed to upholding the highest standards in process-based industries. Explore how Dassault Systèmes solutions can elevate your compliance strategies and set a new benchmark for industry excellence. For more information on how you can integrate the **3D**EXPERIENCE platform into your GxP environments, contact us today. [3DEXPERIENCE GxP Compliance Highlight 3](/media/19867) [Contact an Expert](/how-to-buy) (Gxp readiness)More on the 3DEXPERIENCE platform [3DEXPERIENCE Platform Topics](/3dexperience-platform/all-topics) [3DEXPERIENCE Platform Openness](/3dexperience-platform/openness) [Anywhere, Anytime, On Any Device](/3dexperience-platform/anywhere-anytime-any-device) Classic Image as background (GxP Readiness 3DEXPERIENCE FAQ)GxP Compliance FAQs What is GxP in life sciences and in Pharma? GxP stands for "Good Practice" and encompasses a range of quality guidelines essential to the life sciences and pharmaceutical sectors. These include practices like GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and GCP (Good Clinical Practice), each ensuring that products are developed, manufactured, and controlled with safety, efficacy, and traceability in mind. GxP refers to the rigorous guidelines and standards set by regulatory bodies such as the FDA (Food and Drug Administration) in order to ensure safety, quality, and efficacy of products in the life sciences industry. These regulations cover various aspects of production, testing, storage, and distribution of pharmaceuticals, medical devices, biologics, and other healthcare products. The **3D**EXPERIENCE platform is designed with privacy and quality at its core to meet these GxP requirements. Our platform offers secure environments for data management, collaboration, and process automation that comply with strict regulatory standards. This allows companies in the life sciences industry to confidently use our solution without compromising on their compliance obligations. What is a GxP platform? A GxP platform refers to a software or technology solution that is compliant with Good Practices (GxP) regulations set by regulatory agencies such as the Food and Drug Administration (FDA). These regulations aim to ensure that products in the life sciences industry, including pharmaceuticals, medical devices, and biologics, meet certain standards for safety, quality, and efficacy. It is still the responsibility of a customer to validate that their solution is compliant with GxP regulations GxP requirements cover all stages of product development, from production to distribution. They also involve strict guidelines for data management, collaboration, and process automation. It is crucial for companies in the life sciences industry to adhere to these regulations in order to ensure the safety of their products and maintain compliance with regulatory standards. What are the key requirements for GxP compliance? GxP compliance requirements are a set of principles and guidelines that ensure safety, quality, integrity, and traceability in regulated industries like pharmaceuticals, biotechnology, and medical devices. Although there is no single global authority overseeing GxP, most requirements follow standards from agencies like the FDA (21 CFR Part 11), EMA (EU Annex 11), and ISO. Key elements include: - **Documented procedures** for all critical processes - **Data integrity controls**, including secure audit trails and versioning - **Electronic records and signatures** that are traceable and tamper-proof - **Computerized System Validation (CSV)** aligned with GAMP5 or similar guidelines - **Role-based access control** to ensure accountability - **Change control and risk assessment processes** to manage updates and modifications Can software be GxP compliant? Software can be designed or configured to support GxP compliance, but compliance ultimately depends on how the software is used within a validated process. This means software must: - Be validated by the customer for its intended use - Support electronic signatures and audit trails - Provide evidence of data integrity and system controls Not all software in an organization needs to be GxP-compliant—only those used in regulated workflows that impact product quality, patient safety, or data reporting. The benefit of the 3DEXPERIENCE platform is that it can be used in both regulated and non-regulated environments, preserving data, knowledge, and know-how across all parts of an organization. What are the different types of GxP regulations? GxP includes GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice). Each applies to a specific domain within the life sciences and has unique compliance requirements. Why is audit readiness important in GxP environments? In GxP settings, being audit-ready means more than having documents in place—it means operating with full traceability and control at all times. Regulatory audits can occur with little notice, and non-compliance can result in serious consequences, including product recalls or halted approvals. Audit readiness requires robust change tracking, user accountability, validated systems, and immediate access to evidence proving compliance—such as validation reports, training logs, and system configuration histories. Join the 3DEXPERIENCE platform user community Connect with peers, experts, and partners all around the world to share best practices and expertise. [Join](https://r1132100503382-eu1-3dswym.3dexperience.3ds.com/#community:4) Buy online Get started today, because your best ideas can't wait. Make it come to live on the **3D**EXPERIENCE platform. [Buy ](/store) Contact Sales Let's talk about your needs. Speak with a **3D**EXPERIENCE platform expert. [Contact ](https://discover.3ds.com/my3dexperience-contact-sales) ![GxP Compliance and readiness on the 3DEXPERIENCE platform > Dassault Systemes](https://www.3ds.com/assets/invest/2025-02/3dexperience-gxp-compliance-1920x626.jpg) GxP Readiness