Terms of Service

Last updated: 2026-07-10.

1. The service

CAPAPath is a software service for managing Corrective and Preventive Action (CAPA) and related quality records. It is intended for business use by regulated organizations and is designed to support 21 CFR Part 11-style controls (an audit trail, electronic signatures, access control, and record versioning). By using the service, you agree to these terms on behalf of yourself and the organization you represent.

2. Accounts and authorized users

Accounts are issued to named individuals authorized by a customer organization. Each account is personal to one individual — credentials must never be shared, and you must not act under another person's account. You are responsible for all activity under your account and for keeping your password confidential. Notify us promptly if you believe your account has been compromised.

3. Electronic signatures

When you apply an electronic signature in CAPAPath, you affirm that it is the legally binding equivalent of your handwritten signature (21 CFR Part 11.100(c)) and that you will not repudiate a signature you have executed. Because signatures establish accountability for regulated records, you are solely responsible for the confidentiality of the credentials used to sign, and you must re-authenticate when the service prompts you to.

4. Your compliance responsibilities

CAPAPath provides technical controls; it does not, by itself, make your quality system compliant. You remain responsible for your own procedures, for validating the service for your intended use (e.g. IQ/OQ/PQ against your configuration), for the accuracy and completeness of the records you enter, and for meeting the regulatory obligations that apply to your organization. We can provide documentation to support your validation on request.

5. Your data

The quality records you create remain yours (or your organization's). We process them to provide the service and act as a data processor on your organization's behalf. See the Privacy Policy for details, including how the immutable audit trail is retained.

6. Acceptable use

Don't use the service for anything unlawful, don't attempt to disrupt it or gain unauthorized access, and don't tamper with or attempt to circumvent its audit, signature, or access controls. We may suspend or remove access for violations.

7. Availability and no warranty

The service is provided on an "as is" and "as available" basis without warranty of any kind. To the maximum extent permitted by law, we are not liable for indirect, incidental, special, or consequential damages. Nothing in the service is legal or regulatory advice.

8. Term and termination

Either party may terminate use of the service. Before your data is deleted you will have an opportunity to export it; note that records subject to regulatory retention should be retained by your organization for their required period. We may suspend or terminate access that violates these terms or exposes the service to legal risk.

9. Changes

We may update these terms; the "last updated" date above will change. Continued use after an update constitutes acceptance of the new terms.

10. Contact

Questions: /contact.