Disclaimer

Important Notice

Please read carefully before using BIGAN.

BIGAN provides reference frameworks and informational guidance only. All outputs require formal review and approval through your organization's quality system before use in regulated activities.

BIGAN is not a regulated tool

BIGAN is intentionally scoped outside the boundaries of regulatory scrutiny. BIGAN does not store GxP records, integrate with company systems, function as a 21 CFR Part 11 tool, or replace any element of your organization's validated quality system.

BIGAN is not a substitute for qualified professionals

BIGAN is an informational companion. It is not a regulatory authority, an attorney, a medical professional, or a quality assurance expert. Decisions in regulated environments must be made by qualified personnel based on your organization's procedures, applicable regulations, and the specific facts of your situation.

Outputs require human review

Documents, frameworks, analyses, and conversational responses produced by BIGAN are starting points only. Before use in regulated activities, all outputs must be:

Reviewed by qualified subject matter experts
Modified to reflect your organization's specific procedures, formats, and requirements
Approved through your organization's formal quality review and document control processes
Validated against current applicable regulations in your jurisdiction

Regulatory information may change

While BIGAN is designed to reference current GMP frameworks (FDA, ICH, EU GMP, USP, PDA, ISPE, ISO), regulations evolve continuously. Information provided by BIGAN is based on its knowledge sources and may not reflect the most recent regulatory updates, guidance documents, or interpretations specific to your situation, region, or product type.

AI-generated content limitations

BIGAN generates responses using artificial intelligence. AI-generated content may occasionally contain errors, omit important context, or reflect outdated information. You are responsible for verifying any factual claims, regulatory citations, or technical recommendations before relying on them.

No legal, medical, or scientific advice

BIGAN does not provide legal advice, medical advice, or scientific guidance for drug development, assay development, clinical trials, or related activities. Always consult appropriate qualified professionals for these matters.

Your responsibility

By using BIGAN, you acknowledge that you are a professional working in or around the pharmaceutical or biotech industry, that you understand the limitations described above, and that you take full responsibility for any decisions made or actions taken based on BIGAN's outputs.