These Terms & Conditions (“Terms”) govern access to and use of the OneXPro website and the OneXPro QMS (Change Control) and Controlled Spreadsheet Review services (the “Services”) provided by OneXPro LLC (“OneXPro”, “we”, “us”). Please read them carefully.
1. Scope and acceptance
By using the website or the Services you agree to these Terms. If you use the Services on behalf of a company, you confirm that you are authorised to bind it, and “you” means that company. Where a company has signed an order form, master subscription agreement, data processing agreement or quality agreement with us, that document prevails over these Terms to the extent of any conflict.
2. Definitions
- Customer — the company that subscribes to the Services.
- Company Admin — the person the Customer appoints to administer its users, departments, settings and flows.
- User — an individual the Customer authorises to use the Services under their own account.
- Customer Data — all records, files, signatures, audit trails and other data entered into or generated in the Services for the Customer.
- Documentation — our user guidance, release information and validation package.
3. Accounts and access
- Each account is personal to one individual. Accounts, usernames and passwords must not be shared, transferred or reused.
- The Customer is responsible for creating, reviewing and disabling Users' accounts promptly — including when a person changes role or leaves — and for the actions of its Company Admin and Users.
- Users must keep their passwords confidential, replace temporary passwords at first sign-in, and tell their Company Admin immediately of any suspected unauthorised use.
- Accounts are disabled rather than deleted so that the identity behind past signatures and audit-trail entries is preserved.
4. Electronic signatures
An electronic signature applied in the Services records the signer's identity, the meaning of the signature and the date and time, and requires the signer to re-enter their password. Each User agrees that their electronic signature in the Services is intended to be the legally binding equivalent of their handwritten signature for the records they sign. The Customer is responsible for any certification to regulatory authorities that its electronic signatures are intended to be equivalent to handwritten signatures (for example under 21 CFR §11.100(c)).
5. Regulatory responsibility
The Services include technical controls designed to support compliance with 21 CFR Part 11, EU GMP Annex 11 and data-integrity expectations, described on our Compliance & Security page. Compliance, however, depends on how a system is validated and used. The Customer remains responsible for:
- validating the Services for its intended use, including installation, operational and performance qualification;
- its standard operating procedures, including access management, electronic-signature use and audit-trail review;
- training its Users and keeping training records;
- configuring departments, designations, flows and permissions so that they reflect its approved procedures;
- deciding retention periods and the content of its records.
We provide the Documentation and, where agreed, implementation and validation support to assist with these responsibilities.
6. Acceptable use
You must not, and must not allow anyone to:
- use the Services in breach of law or regulation, or to store unlawful, infringing or malicious content;
- attempt to access another customer's data, bypass access controls, or probe, scan or test the vulnerability of the Services without our written permission;
- attempt to alter, falsify or delete records, signatures or audit trails other than through the functions the Services provide;
- introduce malware, overload the Services, or interfere with their operation;
- copy, modify, reverse engineer or create derivative works of the Services, except as permitted by law;
- resell, sublicense or provide the Services to third parties other than as agreed with us.
7. Customer Data
- The Customer owns its Customer Data. We process it only to provide, secure and support the Services, on the Customer's instructions and as described in our Privacy Policy and any data processing agreement.
- We keep each Customer's data in a database and storage bucket dedicated to that Customer and apply the security measures described on our Compliance & Security page.
- The Customer is responsible for the accuracy and lawfulness of Customer Data and for having the rights and notices needed for us to process it, including personal data of its Users and principal parties.
- On termination, we will make Customer Data available for export in an agreed format for a reasonable period and then delete it, except where we are required by law to retain it.
8. AI features
Optional AI drafting features generate suggested text. Suggestions may be incomplete or inaccurate. They are never saved or signed automatically: a User must review, edit as needed and take responsibility for any text they save and sign. AI output must not be relied on as a regulatory or quality decision.
9. Service, changes and support
- We will use commercially reasonable efforts to keep the Services available, secure and performing as described in the Documentation. Specific service levels apply only if set out in a signed agreement.
- We may improve and change the Services. Changes to documented compliance controls are recorded in our release information and validation package so the Customer can assess them under its own change control. We will not materially reduce the core functionality of a subscribed Service during a paid term.
- Planned maintenance will be scheduled to minimise disruption, with notice where reasonably practicable.
- Support is provided by e-mail at support@onexpro.com, and as otherwise agreed.
10. Intellectual property
The Services, website, software, Documentation and all related intellectual property belong to OneXPro LLC or its licensors. Subject to these Terms and payment of applicable fees, we grant the Customer a non-exclusive, non-transferable right for its Users to use the Services for its internal business purposes during the subscription term. Feedback you give us may be used to improve the Services without obligation.
11. Confidentiality
Each party will keep the other's confidential information confidential, use it only for the purposes of the relationship, and protect it with at least reasonable care. Customer Data is the Customer's confidential information. These obligations do not apply to information that is public, already known, independently developed or lawfully received from a third party, and do not prevent disclosure required by law.
12. Fees
Fees, billing periods and payment terms are set out in the Customer's order form or agreement. Unless stated otherwise, fees are exclusive of taxes, which the Customer will pay as applicable.
13. Term, suspension and termination
- The subscription runs for the term in the order form and renews as stated there.
- We may suspend access if needed to prevent a security threat or serious harm, or for material non-payment after notice. We will limit any suspension to what is necessary and restore access promptly once the cause is resolved.
- Either party may terminate for the other's material breach that is not remedied within 30 days of written notice.
- On termination, the right to use the Services ends and section 7 governs the return and deletion of Customer Data. Sections that by their nature should survive (including confidentiality, liability and intellectual property) survive termination.
14. Warranties and disclaimers
We warrant that we will provide the Services with reasonable skill and care and that they will perform materially as described in the Documentation. Except as expressly stated in these Terms or a signed agreement, the Services and the website are provided “as is” and “as available”, and we disclaim all other warranties to the extent permitted by law, including implied warranties of merchantability, fitness for a particular purpose and non-infringement. We do not warrant that use of the Services alone will make the Customer compliant with any law or regulation.
15. Limitation of liability
To the extent permitted by law: (a) neither party is liable for indirect, incidental, special or consequential damages, or for loss of profits, revenue or goodwill; and (b) each party's total liability arising out of or in connection with the Services in any twelve-month period is limited to the fees paid or payable by the Customer for the Services in that period. These limits do not apply to liability that cannot be limited by law, to a party's fraud or wilful misconduct, to breach of confidentiality, or to the Customer's payment obligations.
16. Indemnities
We will defend the Customer against third-party claims that the Services, as provided by us, infringe that third party's intellectual property rights, and pay resulting damages finally awarded. The Customer will defend us against third-party claims arising from Customer Data or from use of the Services in breach of these Terms. The indemnified party must give prompt notice, reasonable cooperation and control of the defence.
17. Governing law and disputes
These Terms are governed by the law and courts specified in the Customer's signed agreement with us or, where there is none, by the laws of the jurisdiction in which OneXPro LLC is organised. The parties will first try in good faith to resolve any dispute through discussion between senior representatives.
18. General
- Changes to these Terms: we may update these Terms; the date above shows the latest version. Material changes affecting existing customers take effect at the next renewal or with at least 30 days' notice.
- Force majeure: neither party is liable for delay caused by events beyond its reasonable control.
- Assignment: neither party may assign these Terms without the other's consent, except to a successor in a merger or sale of substantially all of its business.
- Severability and waiver: if any provision is unenforceable, the rest remains in effect; failure to enforce a right is not a waiver.
- Entire agreement: these Terms, together with any signed agreement and our Privacy Policy, are the entire agreement on their subject.
19. Contact
Questions about these Terms: support@onexpro.com.