eTechflow LLC · Supplement SafetyOps
These terms are between eTechflow LLC, a Colorado limited liability company ("we", "us"), and the business installing Supplement SafetyOps ("you", "the merchant").
By installing or using the app you accept these terms. If you are accepting on behalf of a company, you confirm you are authorised to do so.
Our Privacy Policy and Retention Policy form part of this agreement. Your use of Shopify is also governed by Shopify's own terms, which we are not a party to.
SafetyOps helps you receive, investigate, document and prepare reports about product-safety complaints and adverse events relating to dietary supplements you sell. It includes intake, case management, deadline tracking, seriousness assessment support, evidence handling, audit trails, and report preparation.
We do not make regulatory decisions, and we do not file reports for you. You decide whether an event is serious, whether it is reportable, and whether to submit. You make the submission.
We describe our controls as Part 11-supporting. We do not claim the product is Part 11 compliant, FDA approved, FDA certified or HIPAA certified. Compliance depends on how the software and your own procedures work together.
You are the party regulated by the FDA, not us. You are responsible for:
Subscription charges are handled through Shopify's Billing API, at the tier you select. Pricing and tier limits are shown on our Shopify App Store listing and in the app.
Paying for a lower tier never disables safety functions. Tier limits do not gate case creation, seriousness assessment, deadline tracking, evidence storage or the audit trail. We will not put a merchant in breach of a legal obligation to upsell them.
Charges are billed in advance and are non-refundable except where required by law. If you exceed a tier limit we will tell you before any change to your charges.
Your data remains yours. We process it to provide the service, on your instructions, as set out in the Privacy Policy.
For consumer personal data handled through the app, you are the controller and we are the processor. We will enter into a data processing agreement with you on request, on terms reflecting this Privacy Policy.
We never use your data or your consumers' data for marketing, advertising, resale, or training AI models.
You will be able to export your data at any time while your subscription is active. The compliance archive export is Planned and will be in place before the app is available to any merchant — we will not take a subscription for a records system you cannot get your records out of.
We aim to keep the service available, but we do not guarantee uninterrupted access. Planned maintenance will be notified in advance where practical.
Your regulatory deadlines keep running even if our service is down. We provide an offline submission checklist today, as SOP-010 in the SOP pack issued to every merchant. A status page and an in-app emergency export procedure are Planned and ship before launch; their current status is shown in our Trust Centre. You must have a procedure for reporting directly through the FDA's own portal if we are unavailable. We are never your only route to submit.
You must not use SafetyOps to break the law, attempt to access another merchant's data, interfere with the service's security or performance, reverse engineer it, resell access without our agreement, or upload malicious files.
We may suspend access if we reasonably believe continued use presents a security risk — and we will preserve your records if we do.
You can uninstall at any time. We may end this agreement for material breach, or for non-payment, with reasonable notice.
Uninstalling stops processing. It does not destroy your records. On uninstall we stop API access, revoke credentials, record the time, notify your account owner, make a controlled export available, and preserve records you are legally required to keep.
You are responsible for downloading and securely retaining your regulatory records before uninstalling SafetyOps. SafetyOps provides tools to export case records and supporting documentation. Uninstalling the application terminates Shopify billing and may result in deletion of data in accordance with Shopify's mandatory privacy requirements and our retention policy. eTechflow LLC is not responsible for records that a merchant fails to export before the applicable deletion deadline.
The six-year recordkeeping duty is yours as the regulated party. To help you meet it:
Shopify requires us to erase your store's data after uninstall, and sends that instruction 48 hours after you leave. The export link remains available only for the period Shopify's requirements permit. See the Retention Policy for detail.
We own the software, its design and documentation. You get a non-exclusive, non-transferable right to use it while your subscription is active.
You own your data and your content. You grant us only the permissions needed to run the service for you.
We provide the service with reasonable skill and care. Beyond that, and to the fullest extent permitted by law, the service is provided "as is" without further warranties.
We do not warrant that using SafetyOps will make you compliant with any law or regulation.
Nothing in these terms limits or excludes either party's liability for death or personal injury caused by negligence, for fraud or fraudulent misrepresentation, for wilful misconduct, or for anything else that cannot lawfully be limited or excluded.
SafetyOps is a record-keeping and workflow tool. As set out in sections 3 and 4, you are the party regulated by the FDA. You decide whether an event is serious, whether it is reportable, when Day 0 falls, and whether and when to submit. You make the submission. We do not make those decisions and we cannot make them for you.
Accordingly, we are not liable for a regulatory determination you make, for a report you do not submit, for a submission you make late, or for the accuracy of information you or your staff enter into the service.
Deadline calculations are a tool to help you track your obligations. They do not replace your own verification. Every calculation is shown with the days counted and excluded, and with the calendar version used, so that you can check it — and you are responsible for checking it.
Your reporting deadlines continue to run whether or not our service is available. As set out in section 7, you must maintain a procedure for submitting directly through the FDA's own portal if we are unavailable, and we are never your only route to submit. We are not liable for a deadline missed during an interruption where you did not follow that procedure.
A complete compliance archive is downloadable from your dashboard at any time throughout your subscription. As set out in section 9, you are responsible for exporting and securely retaining your regulatory records, including before you uninstall. We are not liable for records you did not export within the periods described in these terms and in our Retention Policy.
This does not relieve us of our own obligation to keep your records available to you while your subscription is active, and to make the export available as described.
To the fullest extent permitted by law, and subject to section 12.1, we are not liable for:
This applies whether the claim is in contract, tort (including negligence), breach of statutory duty or otherwise, and whether or not we were advised the loss was possible.
Subject to section 12.1, our total aggregate liability arising out of or in connection with these terms and your use of SafetyOps, in any twelve-month period, is limited to the total subscription fees you paid us in the twelve months immediately before the event giving rise to the claim.
Where you have paid us less than US$500 in that period, our total aggregate liability is limited to US$500.
You will indemnify us against claims, losses and reasonable costs arising from your use of SafetyOps in breach of these terms, from content you upload that you had no right to upload, or from a regulatory determination or submission you made.
The allocation of risk in this section reflects the subscription fees charged. The fees would be materially higher if we assumed liability for your regulatory outcomes. These limits apply even if a limited remedy is found to have failed of its essential purpose.
These terms are governed by the laws of the State of Colorado, United States, and the courts of Colorado have exclusive jurisdiction.
We may update these terms. Material changes will be notified to your account owner in advance. Continuing to use the service after a change takes effect means you accept it.
For privacy enquiries, security or vulnerability reports, and support:
etechflow0@gmail.com