Terms of Service

1. The Service

Plumely is a browser-based, multi-tenant SaaS platform offering a library of modular compliance tools — supplier and CoA qualification, deviation and CAPA tracking, stability studies, export documentation, protocol amendments, country dossier checklists, an RLD/Orange Book comparator, and a clinical trial lite manager — that an organization can activate individually. The Service is provided on an “as is” and “as available” basis.

2. Accounts and organizations

An account belongs to one person; an organization is the workspace your compliance data lives in, with its own membership, roles, and per-tool permissions. Organization administrators control who is a member, what role they hold, and which tools are active. You are responsible for safeguarding your own credentials and for actions taken under your account, including actions your organization's administrators authorize you to take.

3. Your data

Your organization retains all rights to the compliance records, documents, and other content it enters into the Service (“Customer Data”). We do not claim ownership of Customer Data. We process it solely to provide the Service, as described in the Privacy Policy, and we do not use it to train models or for any purpose unrelated to operating Plumely for your organization.

4. Compliance is a shared responsibility

Plumely provides tools that support common practices expected under frameworks such as 21 CFR Part 11 — an append-only, hash-chained audit trail, an electronic-signature mechanic on certain records, and a PHI-minimized data model for the Clinical Trial Lite tool. Using these tools does not, by itself, make your organization's processes compliant with any regulation. Your organization remains responsible for validating its own procedures and use of the Service against the regulations that apply to it (which may include 21 CFR Part 11, HIPAA, GDPR, CDSCO requirements, or others), and for putting any required agreements in place — for example, a Business Associate Agreement before entering real participant data into the Clinical Trial Lite tool.

5. Acceptable use

You agree not to use the Service to:

• ✓Store or process data you are not legally authorized to hold, or that violates the rights of others.
• ✓Circumvent, disable, or attempt to bypass any access control, permission check, or row-level security policy in the Service.
• ✓Attempt to access another organization's data, or interfere with or disrupt the Service.
• ✓Reverse engineer the Service beyond what applicable law expressly permits.

6. Tool activation and paid plans

Tools may be activated for your organization on a trial or a paid basis. Pricing, billing terms, and the tools included will be described at the point of purchase or in your order form. We may suspend or deactivate a tool or account for non-payment or a material breach of these Terms, on notice where practical.

7. Platform administration

A small number of Plumely operators hold platform-wide administrative access, used only to operate, support, or secure the Service — for example, diagnosing an issue or, in limited cases, adjusting an organization's tool access directly. This access is not self-service, is not visible to or controllable by regular users, and any change it makes to an organization's tool access is logged to that organization's own audit trail.

8. Intellectual property

The Service itself — including its software, design, and branding — is owned by Plumely and its licensors and is protected by intellectual property laws. These Terms grant you only a limited, revocable, non-transferable license to use the Service in accordance with these Terms.

9. Disclaimer of warranties

The Service is provided without warranties of any kind, whether express or implied, including fitness for a particular purpose and non-infringement. We do not warrant that the Service will be uninterrupted or error-free. Your organization is responsible for reviewing and validating any output of the Service before relying on it for a regulatory submission, inspection, or other compliance purpose.

10. Limitation of liability

To the maximum extent permitted by law, Plumely will not be liable for any indirect, incidental, special, consequential, or punitive damages, or any loss of data, revenue, or profits, arising from your use of the Service.

11. Changes to the Service and Terms

We may modify the Service or these Terms at any time. Material changes to these Terms will be posted here with an updated date. Continued use of the Service after changes take effect constitutes acceptance of the updated Terms.

12. Contact

Questions about these Terms? Email hello@plumely.online.