Terms of Use

1 Scope and acceptance

By signing in or using the application, you confirm that you are an authorized user of a subscribing organization and that you accept these terms. If you do not agree, do not use the system.

2 The service

Trakcen eQMS is a multi-tenant electronic quality management system. It supports controlled documents, workflows, electronic signatures, training and competency records, notifications, and audit trails intended for regulated environments (including life sciences and medical device quality systems).

3 Accounts, credentials, and roles

• Access is granted by your organization. Usernames, passwords, and permissions must not be shared.
• You may only perform actions allowed by your assigned role and company context.
• You must keep your credentials confidential and notify your administrator immediately if you suspect unauthorized use.

4 Acceptable use and data integrity

You must not attempt to bypass security controls, alter audit evidence, impersonate another user, or use the system in a way that compromises data integrity (ALCOA+), traceability, or regulatory obligations of your organization.

Business decisions—such as approving a document, signing a record, or forcing a controlled transition—must reflect your intentional action and assigned authority.

5 Electronic records and signatures

Operations you perform in Trakcen eQMS may generate electronic records and electronic signatures subject to your organization's policies and applicable regulations (e.g. 21 CFR Part 11, ISO 13485, MDSAP). You are accountable for the meaning and consequences of actions executed under your identity.

6 Intellectual property and confidentiality

The platform, its software, and Trakcen branding remain the property of Trakcen. Content uploaded or created by your organization remains subject to your company's ownership and confidentiality rules.

7 Availability and changes

We strive to maintain a secure and available service. Planned maintenance or updates may occur. We may revise these terms; the current version will always be published on this page. Continued use after publication constitutes acceptance of the updated terms.

8 Questions and support

For contractual, licensing, or support matters, contact your organization's Trakcen administrator or the support channel defined in your company's agreement with Trakcen.