ValGenesis AI Responsibility Statement 

Scope and Governance

ValGenesis will maintain governance processes to oversee AI-related risks, approve or escalate material AI use cases as appropriate, and support compliance with this Statement and applicable internal policies. Before deployment, higher-risk AI use cases will undergo a risk-based assessment that considers the intended use, affected users, data involved, level of autonomy, reasonably foreseeable errors or misuse, potential bias, cybersecurity, regulatory or GxP significance, third-party dependencies, and required human oversight. The level of review and control will reflect the nature of the AI capability, the data involved, the intended use, and potential impact on individuals, customers, or regulated activities.

Human Accountability and Oversight

AI will support but not replace human judgment and accountability. We will assign accountable owners for AI-enabled or AI integrated  capabilities and apply human oversight standards proportionate to the capability’s intended use, potential impact, and risk. ValGenesis personnel and customers remain responsible for reviewing and validating AI-generated outputs before relying on them in decisions, regulated activities, or other consequential uses.

Quality, Reliability, and Risk Management

We apply documented, risk-based practices throughout the AI lifecycle, including design or procurement, testing, deployment, monitoring, change management, and retirement. Before deployment, AI-enabled capabilities will be evaluated for their intended use, limitations, reliability, potential impact, and reasonably foreseeable misuse. Controls will be proportionate to risk and may include testing, validation, performance monitoring, access restrictions, incident response, escalation, and, where appropriate, rollback or disablement capabilities. ValGenesis may assess and manage material changes to models, providers, dependencies, configurations, or performance, including model drift, and will conduct risk-based re-assessment, testing, documentation, and customer communication where appropriate. Where AI is used in regulated environments, we will maintain controls consistent with applicable quality and regulatory  requirements.

Transparency

We will provide information appropriate to the context about material AI functionality in our products and services, including relevant capabilities, limitations, intended use, and required human review. For this purpose, “material AI functionality” means  functionality that materially generates, recommends, predicts, classifies, automates, or otherwise influences a customer workflow, record, decision, or regulated process. We will not represent AI-generated outputs as infallible, independently verified, or a substitute for required professional, scientific, quality, or regulatory judgment.

Privacy and Data Protection

We will protect personal data, confidential information, and customer information used in connection with AI technologies. AI-enabled or AI-integrated capabilities will be designed and operated in accordance with applicable privacy, data protection, security, intellectual-property, and contractual requirements. We will implement controls appropriate to the data and use case, including data minimization, authorized-access controls, retention controls, and restrictions on disclosure or reuse, as applicable. ValGenesis will not use customer data, including customer confidential information, personal data, prompts, or outputs, to train generalized AI models except as authorized by the customer, required by applicable law, or otherwise expressly disclosed and agreed in an applicable written agreement.

Security

AI-enabled or AI-integrated capabilities will be developed and operated with safeguards designed to protect the confidentiality, integrity, and availability of information and systems. We will assess and manage security risks throughout the lifecycle, including risks arising from unauthorized access, data leakage, prompt injection, model or dependency vulnerabilities, andmisuse. Security incidents involving AI-enabled capabilities, including unauthorized disclosure through prompts or outputs, compromised dependencies, or material improper model behavior, will be handled under applicable ValGenesis incident management processes. We will notify affected customers of a security incident in accordance with applicable law and the applicable written agreement.

Third-Party AI Suppliers

Where ValGenesis uses third-party AI suppliers or components, we will apply risk-based due diligence and controls appropriate to the service and data involved. These may include security and privacy review, contractual restrictions on data use and disclosure, sub-processor oversight, evaluation of material provider changes, and contingency measures appropriate to the risk.

Fairness and Responsible Use

We will assess reasonably foreseeable risks of unintended bias, discrimination, unsafe recommendations, inaccessibility, or other harmful outcomes and implement mitigations proportionate to the use case and risk. AI technologies may be used only for legitimate business purposes and in a manner consistent with applicable law, ethical business practices, and ValGenesis policies. ValGenesis will not knowingly use AI to enable unlawful discrimination, deception, fraudulent or impersonation based content, circumvention of quality, safety, security, privacy, or access controls, or other prohibited conduct. AI must not be used as a substitute for required expert review, approval, or validation, or to make solely automated consequential decisions where prohibited by law or inappropriate for the use case.

AI Awareness, Literacy, and Employee Training

Responsible AI depends on effective governance and on the people who develop, procure, deploy, administer, and use AI-enabled capabilities.

ValGenesis will promote AI awareness and literacy across the organization through guidance, education, and role-based training. Training will address the responsibilities of personnel who develop, procure, deploy, administer, or use AI-enabled  capabilities.

Training and guidance will address appropriate AI use, data privacy, security, confidentiality, intellectual property, quality, regulatory compliance, limitations and verification of AI-generated outputs, human oversight, and the escalation of suspected errors, misuse, or harmful outcomes.

Regulatory and GxP Considerations

As a technology provider, ValGenesis recognizes that customers may use AI-enabled or AI-integrated capabilities in environments subject to regulatory and GxP requirements. We will apply a risk-based approach and provide documentation and transparency appropriate to the capability to support customers’ evaluation of its use in regulated processes, including, where appropriate, information supporting assessment of intended use, data integrity, computerized-system assurance or validation, and applicable electronic-records and electronic-signature requirements. ValGenesis is responsible for the controls,documentation, and commitments within its control. Customers remain responsible for their intended use, configuration, validation, and regulated decisions, except to the extent otherwise expressly agreed in writing.

AI does not eliminate the responsibility of organizations or individuals to determine whether a system, output, or process is fit for its intended use, appropriately validated where required, and compliant with applicable regulatory requirements. AI will not independently make or execute GxP-relevant approvals, product-release decisions, safety determinations, or regulatory determinations unless the capability, applicable controls, and customer’s intended use have been appropriately assessed and approved.

Regulatory and GxP Considerations

As a technology provider, ValGenesis recognizes that customers may use AI-enabled or AI-integrated capabilities in environments subject to regulatory and GxP requirements. We will apply a risk-based approach and provide documentation and transparency appropriate to the capability to support customers’ evaluation of its use in regulated processes, including,where appropriate, information supporting assessment of intended use, data integrity, computerized-system assurance or validation, and applicable electronic-records and electronic-signature requirements. ValGenesis is responsible for the controls, documentation, and commitments within its control. Customers remain responsible for their intended use, configuration, validation, and regulated decisions, except to the extent otherwise expressly agreed in writing.

AI does not eliminate the responsibility of organizations or individuals to determine whether a system, output, or process is fit for its intended use, appropriately validated where required, and compliant with applicable regulatory requirements. AI will not independently make or execute GxP-relevant approvals, product-release decisions, safety determinations, or regulatory
determinations unless the capability, applicable controls, and customer’s intended use have been appropriately assessed and approved.

Governance and Continuous Improvement

AI governance is an ongoing discipline. ValGenesis will periodically assess developments in AI technology, applicable law, industry standards, regulatory expectations, and emerging risks; monitor AI-enabled capabilities as appropriate to their risk; and update its governance, controls, training, and practices when warranted. We will maintain risk-appropriate records to  support traceability, investigation, and validation, which may include the applicable model or provider, version, material configuration, testing and approval evidence, change history, monitoring findings, and incident records. Suspected AI-related quality events, data-integrity concerns, and deviations will be escalated through applicable quality-management and incident management processes. Personnel may report suspected AI-related risks, errors, misuse, or policy concerns through applicable ValGenesis reporting and escalation channels.

Our Commitment

ValGenesis is committed to advancing AI in support of life sciences organizations’ quality, compliance, and operational excellence objectives. We believe that responsible AI requires accountable governance, risk-based safeguards, transparency,  security, human oversight, capable personnel, and collaboration with customers and partners.

Nature of This Statement

This Statement is a non-contractual description of ValGenesis’ current principles and governance approach for the responsible development, deployment, and use of artificial intelligence. ValGenesis may update this Statement from time to time to reflect developments in technology, law, regulation, standards, and industry practice. This Statement does not create obligations or amend any agreement between ValGenesis and a customer. If this Statement conflicts with an applicable written agreement between ValGenesis and a customer, that written agreement will control.

Revised on September 2026