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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Do Not Sell or Share My Personal Information

Last updated: April 14, 2026

This page is provided for California residents pursuant to the California Consumer Privacy Act (CCPA) / California Privacy Rights Act (CPRA), and for residents of other US states with similar privacy legislation.

Do We Sell or Share Personal Information?

No. QUIALITECH Consulting LLC does not sell, rent, or share your personal information with third parties for monetary consideration or for cross-context behavioral advertising as defined under the CCPA. We do not use advertising networks, data brokers, or third-party tracking technologies on this website. The only personal data we collect is through our voluntary contact form (name, work email, company, role, message), which is used solely to respond to your inquiry.

Your Rights Under the CCPA / CPRA

Right to Know

You may request disclosure of the categories and specific pieces of personal information we have collected about you in the past 12 months.

Right to Delete

You may request deletion of personal information we have collected from you, subject to certain exceptions permitted by law.

Right to Correct

You may request correction of inaccurate personal information we maintain about you.

Right to Opt-Out

You may direct us not to sell or share your personal information. As noted above, we do not sell or share personal information. However, you may still submit this request for our records.

Right to Limit Use of Sensitive Personal Information

We do not collect sensitive personal information as defined under the CPRA.

Right to Non-Discrimination

We will not discriminate against you for exercising any of your CCPA/CPRA rights.

How to Submit a Request

To submit a verifiable consumer request, please contact us by email. We will need to verify your identity before processing your request. We will respond within 45 calendar days of receipt of a verifiable request.

hello@quialitech.ai

Residents of Other States

Residents of Virginia, Colorado, Connecticut, Texas, Montana, Oregon, Iowa, Indiana, Tennessee, and other states with active privacy laws may also submit requests to exercise their rights under those respective laws by contacting us at hello@quialitech.ai.

Contact

QUIALITECH Consulting LLC 412 W 7th St, Clovis, NM 88101 United States Email: hello@quialitech.ai