Is ComplAI compliant with 21 CFR Part 11?

Yes. ComplAI implements electronic records and electronic signatures that meet the requirements of FDA 21 CFR Part 11, including audit trails, access controls, signature meaning, and non-repudiation.

Can we use our own corporate Word templates?

Yes. ComplAI's document generation uses your uploaded corporate Word templates. The AI fills in the content while preserving your branding, formatting, and document structure.

How does the AI generate documents?

ComplAI sends your project data, confirmed requirements, and system information to Anthropic's Claude AI in a single structured call. The response is validated, inserted into your template, and stored. The AI never sees previous documents to avoid hallucinations.

Is the audit trail truly immutable?

Yes. Audit records are INSERT-only at the application level. No UPDATE or DELETE operations are permitted on audit records, regardless of user role — not even by system administrators.

Can clients (external stakeholders) review and sign documents?

Yes. External signatories receive a secure, time-limited link via email. They can review the document in PDF format and sign using a one-time passcode (OTP) as a second factor — no account creation required.

Does ComplAI support multi-language documentation?

Yes. Documents can be generated in Spanish, English, and Portuguese. Bilingual generation is supported for projects requiring documentation in two languages simultaneously.

Can ComplAI integrate with SAP?

Yes. ComplAI connects to SAP systems via OData REST to extract configuration and master data used in validation documentation, reducing manual entry and improving accuracy.

Is ComplAI hosted in Europe?

Yes, EU region hosting is available. Data residency can be confirmed during onboarding.

What happens when a document is approved?

Upon final approval signature, the document version is automatically escalated (e.g., 0.3 → 1.0), previous versions are marked as Obsolete, and the document enters an immutable state — no further edits are permitted without creating a new version.

Can we validate GAMP5 Category 1, 3, 4, and 5 systems?

Yes. ComplAI supports all GAMP5 software categories. The validation approach, protocol generation, and documentation are adapted to the system's risk category.

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Accessibility Statement

Last updated: April 14, 2026

Our Commitment

QUIALITECH Consulting LLC is committed to ensuring that quialitech.ai is accessible to all users, including people with disabilities, in compliance with the Americans with Disabilities Act (ADA) Title III and Section 508 of the Rehabilitation Act. We strive to conform to the Web Content Accessibility Guidelines (WCAG) 2.1 Level AA published by the World Wide Web Consortium (W3C).

Current Accessibility Features

This website has been designed with the following accessibility features: • Semantic HTML5 structure for proper screen reader navigation • ARIA labels on interactive elements and navigation components • Keyboard navigation support throughout the site • Color contrast ratios meeting WCAG 2.1 AA minimums (4.5:1 for normal text) • Responsive design supporting zoom up to 400% without loss of content • No content that flashes more than three times per second • Meaningful link text and button labels • Language attribute set on the HTML element (lang="en" or lang="es") • Skip navigation support via keyboard

Known Limitations

We are actively working to improve the accessibility of this website. Known areas under review include: • Full keyboard operability review for all interactive components • Enhanced screen reader compatibility for complex UI elements • Additional alt text review for decorative and informational images We are committed to addressing these limitations and conducting regular accessibility audits.

Technical Specifications

This website relies on the following technologies for conformance: • HTML5 • CSS3 / Tailwind CSS • JavaScript (React / Next.js) • WAI-ARIA We have tested this website with modern browsers including Chrome, Firefox, Safari, and Edge on desktop and mobile devices.

Feedback and Contact

We welcome feedback on the accessibility of quialitech.ai. If you experience accessibility barriers or require assistance accessing any content on this website, please contact us: QUIALITECH Consulting LLC Email: hello@quialitech.ai Phone: Available upon request Address: 412 W 7th St, Clovis, NM 88101, United States We will respond to accessibility inquiries within 5 business days and make reasonable efforts to provide the information or functionality through an alternative accessible means.

Formal Complaints

If you are not satisfied with our response, you may contact the U.S. Department of Justice, Civil Rights Division, or file a complaint with the relevant authority in your jurisdiction regarding disability discrimination.