Terms of Service &
Regulatory Notices
Please review the following regulatory statuses, mathematical disclaimers, system protection guidelines, and operational boundaries of the Quote2Batch ERP platform.
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.