Governance & Responsibility
Code of Ethics, AI Policy & Commitment
Our ethical framework is grounded in globally recognized regulatory standards. We believe transparency, in both decisions and the tools used to reach them, is fundamental to responsible innovation in life sciences.
The GKS Code of Ethics
Frameworks for codes of ethics are important because they help individuals understand at least the fundamental principles of the organization they interact with. At Global Key Solutions, we anchor our ethical framework in standards established by the agencies we serve alongside, because if we ask our users to uphold these principles, we must hold ourselves to them first.
Our Guiding Framework: FDA's 14 General Principles
The framework we evaluate and model our conduct against is the 14 General Principles of Ethical Conduct, published by the U.S. Office of Government Ethics and codified at 5 CFR Part 2635.13 These principles govern every FDA employee, the individuals who determine whether drugs, devices, and biologics reach patients and can continue to do so.2 It is important to note that these principles originate from the OGE and apply across the executive branch; they are distinct from the GAO's Standards for Internal Control, which provide organizational control frameworks rather than individual ethical conduct standards.6
While our roots begin with the Food and Drug Administration, the agency whose data, processes, and mission have shaped our work from day one, our vision extends far beyond a single agency. Harmonization, one of our four core tenets, drives us to champion ethical and quality standards across global regulatory bodies.8 We look to frameworks from the ICH, ISPE, PDA, and other international organizations to inform a holistic approach to ethics in life sciences, one grounded in the FDA but built for a global landscape.811
Evaluating Our Ethical Framework
In choosing our ethical foundation, we sought a framework that embodies speed, mobility, customer focus, and the use of independent judgment within a system of accountability. From our own experience engaging with the FDA, notably in requesting large-scale public data, we have observed that, despite the inherent complexities of government decision-making, the agency works toward these ideals in an ethically sound manner.19 The Office of Government Ethics provides a strong appeal process as well, reinforcing the accountability mechanisms we value in our own operations.1
Our Commitment to Innovation & Harmonization in a Responsible, Modern Framework
Transparency is at the forefront of both innovation and competition. While transparency may not always protect commercially valuable information, it is important to carry a balance, not just of the actual decisions and outcomes, but of the tools used to reach them. We are now in a climate where it is not just human-based decisions influencing change; modern technologies and AI systems, and how they are designed and built, are more important than ever.410 Organizations should not just be transparent about decisions and documentation, they should also openly discuss the tools and methods used to reach those decisions.
Our commitment is to modernize ethical frameworks to adapt to new technologies. While constraints such as legislative inertia and bureaucratic process are real, frameworks often lack true enforcement mechanisms, and we believe the private sector has both the opportunity and the responsibility to lead by example.6 The OGE's 14 General Principles provide a comprehensive foundation, and we build on that foundation with a forward-looking philosophy that embraces responsible innovation.1
Driving Ethical AI Adoption in Life Sciences
Beyond our own AI policy, we are actively contributing to the responsible adoption of AI across life sciences. Our approach centers on human-in-the-loop design, ensuring that AI augments rather than replaces qualified professionals at every critical decision point.410 We recognize that understanding regulatory directives, how they are formed, enforced, and evolving, is essential to deploying AI systems that professionals can trust.
We align our AI governance with emerging global standards and actively draw from frameworks established by leading industry organizations: the Parenteral Drug Association (PDA) and its guidance on data integrity management systems,12 the International Society for Pharmaceutical Engineering (ISPE) and its GAMP 5 guidelines for compliant computerized systems, now inclusive of AI/ML considerations in its second edition,11 the harmonization efforts of the ICH,8 the NIST AI Risk Management Framework,5 and the EU AI Act.4 Together, these inform a governance approach that is not anchored to any single jurisdiction but is built for the global regulatory reality our users navigate every day.
AI Policy
Global Key Solutions integrates artificial intelligence into its platform to enhance regulatory data analysis, surface compliance insights, and accelerate quality workflows. We recognize that the responsible use of AI is not optional, it is a core ethical obligation, particularly in a domain where patient safety and regulatory integrity are paramount.510
We are at the forefront of innovation, and pushing the boundaries of technology is central to our mission. With this comes meaningful challenges: educating professionals on the processes that power AI-driven insights, which is why transparency and harmonization are at the core of what we do. Beyond education, we are committed to gathering feedback from users and stakeholders, testing rigorously, and iterating continuously. This cycle of education, feedback, and iteration reflects the S-curves of innovation, where disruptive technologies require sustained investment in learning before they deliver transformative value.13
1. Transparency of AI Systems
We are committed to being transparent about where and how AI is used within our platform. Users will be informed when interacting with AI-generated content, recommendations, or analytics. We disclose the general methodologies behind our AI systems and strive to make outputs explainable to the professionals who rely on them.45
2. Data Provenance & Integrity
All AI-driven insights on the GKS platform are sourced from recognized regulatory agencies, including the FDA, EMA, and other global bodies, with full data provenance maintained at every step. We do not fabricate, hallucinate, or extrapolate data without clear labeling. Where AI models generate summaries or predictions, we clearly distinguish these from verified regulatory records.712
3. Human Oversight & Accountability
AI is a tool to augment professional judgment, not replace it. Critical decisions in quality management, compliance, and regulatory affairs must always involve qualified human reviewers. We design our systems to support, not supplant, the expertise of quality auditors and regulatory affairs professionals.410
4. Bias Mitigation & Fairness
We actively monitor our AI systems for bias in data processing, recommendations, and analytical outputs. We are committed to evaluating and improving our models to ensure they do not systematically disadvantage any group of companies, geographies, or regulatory contexts.5
5. Security & Privacy
AI systems handling regulatory data must operate within strict security and privacy controls. We do not use customer-specific data to train general-purpose AI models. User data processed by AI features remains subject to our Privacy Policy and applicable data protection laws.7
6. Continuous Evaluation
We treat AI governance as a living practice. As regulations evolve, as new AI capabilities emerge, and as our platform grows, we will regularly review and update this policy to reflect best practices and stakeholder expectations.510
7. World-Class Counsel & Technology
It is our policy to source counsel, technology, and advisory expertise from leading professionals and institutions worldwide. We maintain relationships with top-tier advisors in law, technology, and regulatory science to ensure that our platform, practices, and governance reflect the highest standards available.811
Our Commitment
Global Key Solutions is committed to operating at the intersection of technology and regulatory responsibility. As we build tools that influence how professionals prepare for inspections, manage quality systems, and navigate global compliance, we accept the weight of that responsibility.8
We pledge to:
- Uphold the ethical standards set forth by the regulatory agencies we serve alongside, including the FDA’s 14 General Principles of Ethical Conduct.12
- Be transparent not just about the decisions and outcomes our platform helps facilitate, but about the tools, technologies, and methodologies we use to get there.45
- Advocate for the modernization of ethical frameworks to account for AI systems and emerging technologies in regulatory decision-making.10
- Protect the integrity of the data our users depend on, ensuring accuracy, provenance, and reliability at every layer of the platform.712
- Prioritize patient safety above commercial interests in every product and feature decision we make.28
Additional Notes
We also acknowledge that the constraints of modernizing any ethical framework within government include legislative limitations. As noted in both academic and agency texts, frameworks often have no true incentive or legal enforcement mechanism beyond the codes themselves.6 This is why we believe the private sector, including companies like ours, has a role to play in championing ethical standards through practice, not just policy.
This Code of Ethics and AI Policy is a living document. We welcome feedback from our users, partners, and the broader regulatory community as we continue to refine our approach to responsible innovation.8
Citations & References
U.S. Office of Government Ethics. "14 General Principles of Ethical Conduct." 5 CFR Part 2635, Subpart A.
View DocumentU.S. Food & Drug Administration. "Standards of Ethical Conduct for Employees of the Executive Branch." 5 CFR Part 2635.
View DocumentStandards of Ethical Conduct for Employees of the Executive Branch. 5 CFR Part 2635, Code of Federal Regulations.
View DocumentEuropean Parliament. "Regulation (EU) 2024/1689, Artificial Intelligence Act." Official Journal of the European Union, 2024.
View DocumentNational Institute of Standards and Technology. "AI Risk Management Framework (AI RMF 1.0)." NIST AI 100-1, January 2023.
View DocumentU.S. Government Accountability Office. "Standards for Internal Control in the Federal Government." GAO-14-704G, September 2014.
View DocumentU.S. Food & Drug Administration. "21 CFR Part 11, Electronic Records; Electronic Signatures." Code of Federal Regulations.
View DocumentInternational Council for Harmonisation. "ICH Q10: Pharmaceutical Quality System." ICH Harmonised Tripartite Guideline, June 2008.
View DocumentU.S. Food & Drug Administration. "Freedom of Information." 21 CFR Part 20, Public Information.
View DocumentExecutive Office of the President. "Executive Order 14110, Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence." October 30, 2023.
View DocumentInternational Society for Pharmaceutical Engineering. "GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems." Second Edition, 2022.
View DocumentParenteral Drug Association. "PDA Technical Report No. 80: Data Integrity Management System." PDA Journal of Pharmaceutical Science and Technology, 2018.
View DocumentChristensen, Clayton M. "The Innovator’s Dilemma: When New Technologies Cause Great Firms to Fail." Harvard Business Review Press, 1997.
View DocumentEffective Date: February 2026
This document is reviewed and updated periodically. For questions, contact info@globalkeysolutions.net
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