Terms of Service

Protokol is an AI-powered pharmaceutical commissioning and qualification (C&Q) document authoring platform operated by Protokol Ltd ("Protokol", "we", "us", "our").

By accessing or using the Protokol platform, you agree to be bound by these Terms of Service. If you are using the service on behalf of an organisation, you represent that you have authority to bind that organisation.

Current positioning (Phase 1): Protokol is an intelligent document authoring tool. Documents generated by Protokol are intended to be reviewed by qualified professionals, approved through the built-in workflow, and then submitted to your organisation's validated Document Management System. Protokol is not itself marketed as a validated electronic records system during Phase 1.

Registration: You must provide accurate information when creating an account. You are responsible for maintaining the confidentiality of your credentials.

Organisations: The service is provided to organisations (tenants). The person who creates the organisation account is the administrator and is responsible for managing user access and roles.

Roles: Protokol uses a role-based access system: Author, Reviewer, QA Approver, Client, and Admin. Access to document actions is gated by role. You are responsible for assigning roles appropriately within your organisation.

Termination: We reserve the right to suspend or terminate accounts that violate these Terms or are used for prohibited activities.

You agree not to use Protokol to:

- Generate documentation for submission without appropriate professional review and sign-off - Circumvent or attempt to circumvent the audit trail or electronic signature controls - Upload content that infringes third-party intellectual property rights - Attempt to reverse-engineer, decompile, or access the underlying AI models - Use the platform in any way that violates applicable laws or regulations - Share access credentials or allow unauthorised users to access your account

Professional responsibility: Protokol generates AI-assisted draft documentation. It is the responsibility of qualified engineering and QA professionals to review, verify, and approve all documents before submission to any regulatory body or validated system.

Your content: You retain ownership of all documents, specifications, and data you upload or create within Protokol. You grant Protokol a limited licence to store and process your content solely for the purpose of delivering the service.

Our platform: Protokol and its technology, including AI models, algorithms, and user interface, are owned by Protokol Ltd and protected by intellectual property laws. You receive a limited, non-exclusive, non-transferable licence to use the platform during your subscription.

AI outputs: Documents generated with AI assistance are owned by you. We do not claim ownership over generated content. However, Protokol does not warrant that AI-generated content is free from third-party claims.

Our collection and use of personal data is governed by our Privacy Policy. By using the service, you consent to the data practices described there.

Document content: We do not use your pharmaceutical document content to train AI models. Your content is processed solely to deliver the service to you.

Data processing: Where you are acting as a data controller with respect to personal data in uploaded documents, you are responsible for ensuring you have a lawful basis for processing and for complying with applicable data protection law. Protokol acts as a data processor in this context.

Deletion: On account termination, your data will be retained for 90 days and then deleted, except where longer retention is required by applicable law or regulatory obligation.

We aim to provide a reliable service but do not guarantee 100% uptime. Planned maintenance will be communicated in advance where possible.

We reserve the right to modify or discontinue features of the service with reasonable notice. We will not make changes that materially diminish the core document authoring and approval functionality during an active subscription period without providing a full refund option.

Disclaimer: The service is provided "as is". We do not warrant that AI-generated document content will satisfy any particular regulatory requirement or that regulators will accept documents generated using Protokol.

Limitation: To the maximum extent permitted by law, Protokol's aggregate liability to you for any claims arising from these Terms or the service shall not exceed the fees you paid in the 12 months preceding the claim.

Exclusions: We are not liable for indirect, incidental, special, or consequential damages, including loss of profits, data, or goodwill.

Nothing in these Terms excludes liability for death or personal injury caused by negligence, fraud, or any other liability that cannot be excluded by law.

These Terms are governed by the laws of Ireland. Any disputes shall be subject to the exclusive jurisdiction of the courts of Ireland.

If any provision of these Terms is found to be unenforceable, the remaining provisions will continue in full force.

We may update these Terms from time to time. We will notify you of material changes by email or by a notice within the platform at least 14 days before the change takes effect. Continued use of the service after changes take effect constitutes acceptance of the new Terms.

For questions about these Terms, please contact us at hello@withprotokol.com.