Regulatory &
Compliance Notices

1. FDA 21 CFR Part 11 & GMP Status

Quote2Batch is an enterprise software system built with technical structures designed to assist manufacturers in complying with FDA 21 CFR Part 11 regulations and Good Manufacturing Practice (GMP) standards. These include cryptographically secure electronic signatures, detailed system audit trail logs, double-operator approval workflows, and granular role-based permissions.

IMPORTANT NOTICE: Quote2Batch is NOT pre-certified, certified, or endorsed by the U.S. Food and Drug Administration (FDA) or any other international or domestic health authority. The FDA does not pre-certify commercial off-the-shelf software packages. The ultimate responsibility for validating the software's installations, operations, and performance (IQ/OQ/PQ validation) in accordance with the manufacturer's specific Standard Operating Procedures (SOPs) lies solely with the operating company.

2. Formulation & Mathematical Accuracy

Quote2Batch incorporates automated calculation tools, including active ingredient assay percentage adjustments, capsule/liquid overage additions, batch weight scaling, and cost estimation models.

These features are intended to serve as mathematical aids and estimates only. They are not a substitute for professional scientific, biochemical, or quality control verification. Operating manufacturers must independently confirm the mathematical and scientific accuracy of all Master Formula sheets and Batch Manufacturing Records (MBRs) through a qualified supervisor, chemical engineer, or validation specialist prior to compounding or releasing a batch on the production floor.

3. Limitation of Operational Liability

To the maximum extent permitted by applicable law, Quote2Batch, its creators, developers, and licensors shall not be held liable for any operational losses or business interruptions.

This includes, but is not limited to, raw material waste, compounding failures, packaging errors, laboratory out-of-specification (OOS) events, floor downtime, product recalls, distribution delays, or loss/corruption of critical batch or formulation database records. Users operate this system entirely at their own risk.

4. Infrastructure & Security Responsibilities

The operating manufacturer is solely responsible for implementing adequate cyber security and data protection measures.

If configuring local server storage or network shares (UNC/SMB paths) for Master Batch Record storage, the manufacturer must enforce strict directory permissions, local firewalls, encrypted storage (such as BitLocker or Azure encryption), and secure backup routines to prevent unauthorized data exposure, malicious access, or accidental deletion of formulation intellectual property.

5. Clinical, Medical & Labeling Claims

Quote2Batch provides tools to assist in generating FDA-style Supplement Facts Panels (SFP), Nutrition Facts Panels, and manufacturing documentation.

Quote2Batch does not analyze, verify, or warrant the medical efficacy, product toxicity, allergens, safety profiles, or regulatory health claims of any ingredients or finished consumer products. The operating manufacturer is solely responsible for obtaining necessary clinical validations, laboratory assays, and legal approvals for all marketing claims and labeling attached to products manufactured using the system.

6. Disclaimer of Warranties

The Quote2Batch platform and all related services, documentation, and materials are provided to the operating manufacturer for use in their manufacturing operations.

THE SOFTWARE AND ALL RELATED SERVICES ARE PROVIDED "AS IS" AND "AS AVAILABLE", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. QUOTE2BATCH LLC DOES NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, ERROR-FREE, OR SECURE, OR THAT ANY DEFECTS WILL BE CORRECTED.

7. Indemnification & Hold Harmless

You agree to indemnify, defend, and hold harmless Quote2Batch LLC, its officers, directors, employees, agents, and licensors from and against any and all claims, damages, obligations, losses, liabilities, costs, and expenses (including reasonable attorney's fees) arising from: (a) your use of the platform; (b) your violation of these terms; (c) your violation of any third-party right, including any intellectual property or privacy right; or (d) any claim that your use of the platform caused damage to a third party. This indemnification obligation shall survive the termination of your use of the platform and these terms.

8. Governing Law & Jurisdiction

These terms and any disputes arising out of or related to the use of Quote2Batch shall be governed by and construed in accordance with the laws of the State of California, without regard to its conflict of law provisions. Any legal action or proceeding arising under or in connection with these terms shall be brought exclusively in the state or federal courts located in Orange County, California, and the parties hereby consent to the personal jurisdiction and venue of such courts.