Download our White Paper: Literature Monitoring in Pharmacovigilance Challenges and Opportunities. here
Biologit Security and Compliance
When it comes to quality, compliance and security, we hold ourselves accountable to the highest standards. It is in our values to innovate transparently and ethically and we proudly foster a culture of trust and transparency with all our stakeholders.
Information Security Practices
ISO/IEC 27001 is an information security standard that specifies security management best practices and comprehensive security controls.
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Biologit is an ISO 27001:2022 certified company. To achieve and maintain this certification we maintain a comprehensive information security management system (ISMS) across all aspects of company operations and the biologit platform, including transparent and auditable processes for risk management, threat intelligence, security training and continuous improvement.
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The biologit MLM-AI platform is hosted on industry-leading cloud provider Amazon Web Services, running on highly available data centers in the EU. We operate a modern, fully redundant and scalable infrastructure, regularly tested for availability, backups, security and compliance.
Biologit is headquartered in the European Unition (Ireland) and operates its business in full compliance with EU GDPR regulation. Learn more in our data privacy policy.
Industry Standards and Regulatory Guidance
The biologit MLM-AI platform is built and operated according to a software development lifecycle (SDLC) following industry best practices. In particular we follow ISPE GAMP’s “V-Shaped” model to develop solutions that are comprehensively tested and validated.
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biologit MLM-AI is a fully validated platform ready for the life sciences. The biologit SDLC is supported by robust processes for risk management, change control, business continuity and of course, information security.
CFR 21 Part 11 is the regulatory guidance issued by the US Food and Drug Administration (FDA) outlining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. Part 11 establishes requirements that ensure the integrity, authenticity, and confidentiality of electronic records.
CFR 21 Part 11
Biologit MLM-AI was designed for the requirements of the life sciences industry and is fully compliant with FDA CFR 21 Part 11. Key platform features supporting compliance are:
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Full audit trail of user actions with indefinite retention, the audit trail can not be tampered with
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Reporting capabilities for administrators and auditors to inspect the audit trail
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Granular permissions management granting user access to specific resources as required by their roles
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User authentication based on unique user ID and password, and enforcement of string password rules
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Learn more in our CFR 21 Part 11 Compliance Page.
Quality Management System
Biologit has implemented a comprehensive quality management system (QMS) in compliance with best industry practices. Starting with our quality policy our goal is to ensure quality remains central to our culture. We operate all areas of the organization through the prism of robust quality processes from risk management, training, corrective and preventive actions, document control to supplier management, and many others. Our quality processes are routinely audited ensuring continued compliance and improvement.
GxP Compliance
As a company specializing in GxP compliance, we pride ourselves on our in-depth knowledge and expertise in GxP regulations. Our team of safety surveillance experts is highly familiar with GDP (Good Distribution Practices), GVP (Good Pharmacovigilance Practices), GCP (Good Clinical Practices), and other relevant regulations governing various industries, with a proven track record of helping our clients navigate complex regulatory landscapes, ensuring they meet all necessary requirements to maintain compliance and uphold the highest standards of quality and safety.
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The biologit MLM-AI literature monitoring platform was built from the ground up with GxP compliance requirements for literature monitoring of safety events. Learn more about how biologit MLM-AI meets GxP regulatory requirements.
AI Trust and Transparency
Biologit are pioneers in developing trustworthy and standards-driven AI systems for literature monitoring of safety events. We believe transparency is the fastest route to earning trust and increasing adoption of the much needed benefits of AI in pharmacovigilance.
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The AI features of the biologit MLM-AI platform are fully validated following GAMP’s extensions to AI, and follows good machine learning practices put forward by regulatory authorities, such as GMLP (Good Machine Learning Practices) issued by FDA/MHRA/Health Canada. They are supported by robust governance and transparency processes, publicly shared with the industry. As examples:
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Technical details of key machine learning model in model cards and white papers;
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AI functionality is extensive documented and auditable from the platform, allowing informed decisions by users
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Biologit continues to present and discuss topics on AI trust and compliance on industry forums. Check out our events and media sections for recent talks.
Biologit and the EU AI Pact
Biologit has officially joined the EU AI Pact, a voluntary initiative launched by the European Union where companies commit to implementing core pledges that contribute to safe and secure AI and advance their compliance with EU AI Act legislation.
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As a signatory of the AI Pact, Biologit is committed to:
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Adopting an AI governance strategy: Implementing robust frameworks to ensure ethical and responsible AI development.
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Conducting a thorough assessment of AI systems to identify potential risks and ensure compliance with regulatory requirements.
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Promoting AI literacy: Educating employees and stakeholders about AI ethics, principles, and best practices.
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By joining the AI Pact, Biologit continues to demonstrate its leadership in AI transparency and its commitment to building trust with all our stakeholders. This initiative aligns with Biologit's broader mission to innovate transparently and ethically, building AI solutions for pharmacovigilance that are safe and trustworthy.
Environmental, Social and Governance (ESG)
Biologit is dedicated to enhancing healthcare, patient safety, and quality through commitment to strong ESG practices. ​​Our commitment to sustainability is central to our goal of accelerating innovation. We prioritise the UN Sustainable Development Goals, actively promote sustainability, and commit to continual improvement for a healthier future and environment.
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We aim to have happy and healthy employees and a positive workplace culture, driving employee satisfaction and retention, promoting diversity and inclusion, prioritising healthy workplace conditions and employee health and safety.
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We are committed to the highest standards of corporate governance including compliance, leadership transparency and accountability, commitment to equity and equality, and by staying up to date with national and international laws and regulations.
Protection of Human Rights
At biologit we are committed to respecting, supporting and complying with international standards in human rights. Including avoiding infringing on the human rights of others and addressing these impacts where they occur, as set out in the UN Guiding Principles on Business and Human Rights.
These Guiding Principles recognize the role of business enterprises as integral organs of society performing specialized functions, and required to comply with all applicable laws and to respect human rights. We make every effort to embed the responsibility to respect human rights through all business functions.
