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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.

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.

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Industry Standards and Regulatory Guidance

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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.

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.

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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:

  • Full audit trail of user actions with indefinite retention, the audit trail can not be tampered with

  • Reporting capabilities for administrators and auditors to inspect the audit trail

  • Granular permissions management granting user access to specific resources as required by their roles

  • User authentication based on unique user ID and password, and enforcement of string password rules

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.

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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. 

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.

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:

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.

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Ready for Vendor Assessments and Audits

Ready to partner with biologit? Get in touch to start your vendor assessment, learn more about our quality and security processes and how they are used in the biologit MLM-AI platform.

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