AI Validation & QA Documentation Services

We provide consulting and support services related to validation documentation, quality management workflows, and AI‑assisted drafting of technical documents (the "Services"). We may use AI tools to generate draft content based on information and instructions you provide. You remain fully responsible for reviewing, approving, and implementing all deliverables.

We are not your legal counsel, regulatory authority, or notified body. The Services and deliverables are for informational and operational support only and do not constitute legal, regulatory, or compliance advice. You are solely responsible for determining whether any deliverable meets applicable regulatory or quality requirements.

3.1 AI Tools. We may use AI systems to generate draft text, templates, or recommendations. These outputs may contain errors or omissions and are provided "as is" for your internal review.

3.2 Human-in-the-Loop (HITL) Requirement. You acknowledge that LabComplyX provides AI-generated suggestions for document improvement only. You agree that it is your sole responsibility to review, verify, and approve all technical data, safety protocols, and regulatory citations before finalizing any document for internal or external use. AI serves as a decision-support tool only; final authority and legal responsibility reside with your qualified personnel.

3.3 Accuracy & "Hallucination" Disclaimer. LabComplyX does not guarantee the absolute accuracy of AI-generated content. AI models may occasionally produce technically incorrect, outdated, or fabricated information. You must cross-reference all AI-suggested measurements, chemical concentrations, regulatory requirements, and technical parameters against primary source data (e.g., FDA guidance, ISO standards, or validated methods) before use.

3.4 Review and Approval. You must carefully review, verify, and, where appropriate, edit all drafts and deliverables before use. You are solely responsible for all final content that is submitted, approved, or stored in your QMS, validation repository, or regulatory filings.

3.5 Data You Provide. You represent that you have the right to provide all data and documents you supply and that they do not infringe third‑party rights. You will not provide any information that you are prohibited from sharing (e.g., certain patient data) without appropriate safeguards.

4.1 Data Sovereignty. LabComplyX maintains strict data isolation. Customer Data uploaded for the purpose of document improvement, drafting, or analysis is stored in a dedicated tenant-isolated environment and will NOT be used to train, retune, fine-tune, or improve LabComplyX's global AI models, third-party provider models (e.g., OpenAI, Anthropic), or any other entity's models without your explicit written consent.

4.2 Data Protection and Confidentiality. We will use reasonable administrative, technical, and physical safeguards to protect your confidential information and will use it only to provide the Services or as required by law. Where we use third‑party AI tools or hosting providers, we will take commercially reasonable steps to ensure they provide appropriate security and confidentiality commitments.

5.1 Your Ownership of Output. As between LabComplyX and User, User owns all rights, title, and interest in the documents improved, drafted, or created through the platform, including validation reports, SOP drafts, CAPA narratives, and all related AI-assisted deliverables. LabComplyX claims no ownership over User-generated compliance documents or their use within your quality management system, regulatory filings, or internal operations.

5.2 Our Retained Rights. We retain all rights in our underlying methods, workflows, templates, software, and know‑how, including generalized, non‑identifiable learnings from the engagement. No Client Data or Client-specific insights will be incorporated into our global knowledge base or offered to other customers without anonymization and your explicit consent.

Fees and payment terms are specified in the applicable proposal, order form, or online checkout flow. Unless stated otherwise, fees are non‑refundable once Services have been performed. Late payments may accrue interest as permitted by law.

We will perform the Services in a professional and workmanlike manner, using reasonable skill and care. However, we do not guarantee any particular regulatory outcome, inspection result, or approval, even if examples or case studies are discussed.

EXCEPT AS EXPRESSLY STATED, THE SERVICES AND DELIVERABLES ARE PROVIDED "AS IS" AND WE DISCLAIM ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON‑INFRINGEMENT.

To the maximum extent allowed by law, our total aggregate liability arising out of or relating to the Services or these Terms shall not exceed the total fees you paid to us for the specific Services giving rise to the claim in the twelve (12) months preceding the event. In no event shall we be liable for any indirect, incidental, consequential, special, or punitive damages, or for loss of profits, revenue, or data.

Either party may terminate the engagement as described in the applicable order or, if no order applies, upon written notice if the other party materially breaches these Terms and does not cure within thirty (30) days. Upon termination, you remain responsible for paying for Services already performed.

These Terms are governed by the laws of the jurisdiction specified in your engagement agreement, without regard to conflict‑of‑laws rules. Any disputes will be resolved in the courts of that jurisdiction, unless the parties agree to arbitration in writing.

11.1 AI Model Disclosure. LabComplyX uses third-party AI models (e.g., OpenAI GPT-4o, Anthropic Claude) in its document improvement workflow. The specific model version may change over time as new versions are released or better models become available. You acknowledge that these AI models may have different capabilities, limitations, and accuracy profiles.

11.2 System Prompt & Governance. All AI-generated content is governed by a controlled system prompt that explicitly instructs the AI to: (1) never invent technical values or hallucinate data; (2) preserve safety warnings and regulatory requirements; (3) align all improvements with applicable standards (FDA, ISO, CLIA, cGMP); and (4) flag high-risk changes for human review. You may request a summary of the system prompt used for your engagement.

We may update these Terms from time to time. We will post the updated Terms with an updated "Last Updated" date. For ongoing engagements, material changes will apply only prospectively unless you expressly agree otherwise.