Legal

Terms of Service

These terms apply to your use of this website and the platform. If your organisation has signed a separate agreement with us, that agreement takes precedence where the two differ.

01The service

The platform provides master recipes, electronic batch execution, line clearance, deviation management, equipment logs, AI batch review and QA release for manufacturers working under GMP, as described on this website and in your plan.

02Accounts and access

Each user must have their own login. Sharing credentials is not allowed, because electronic signatures and audit trail entries must be attributable to one person.

Your workspace administrator is responsible for granting and removing roles, including who may approve master recipes and who may release batches.

03Your regulatory responsibilities

You remain the manufacturer of record and are responsible for compliance with the GMP rules of the markets you supply, including batch release decisions.

The platform supports, but does not replace, your quality system, your SOPs or the judgement of your authorised personnel.

04Validation

The platform is designed with audit trails, access control and electronic signatures that support 21 CFR Part 11 and EU Annex 11. Validation for regulated use is your responsibility and is carried out under your quality system.

Where your plan or a separate quote includes validation support, we provide documentation and assistance as described in that quote.

05AI Batch Reviewer

The AI Batch Reviewer highlights possible gaps, out-of-limit values, open deviations and unusual patterns for review by your QA team. It does not approve, reject or release batches.

Highlights may be incomplete or occasionally incorrect. Your authorised QA personnel must review the record and make every release decision.

06Your data

You own the records you create in the platform. You grant us only the rights needed to host, process, back up and display them to provide the service.

You can export your records at any time during your subscription, including signed batch dossiers and audit trails.

07Acceptable use

Do not attempt to bypass access controls, alter audit trails, probe the service for vulnerabilities without written permission, or use the service to store content that you have no right to store.

08Fees and billing

Fees are charged per licensed production line per month according to your plan, and are billed annually unless agreed otherwise. Validation and onboarding services are quoted and invoiced separately.

Prices shown on this website are in US dollars and exclude applicable taxes.

09Availability and support

We work to keep the platform available and to schedule maintenance outside common production hours. Support levels depend on your plan.

Shop-floor tablets keep the open step during brief network loss and sync when the connection returns.

10Liability

To the extent permitted by law, we are not liable for indirect or consequential losses, including lost production or product recalls arising from decisions made by your personnel. Our total liability is limited to the fees paid for the service in the twelve months before the claim.

11Ending the service

You may end your subscription at the end of any billing term. Before records are deleted, you will have a period to export them, as set out in your agreement.

We may suspend access if these terms are seriously breached, after notice where possible.

12Governing law

These terms are governed by the laws of India, and the courts of Hyderabad, Telangana have jurisdiction over any dispute.