Compliance

Regulatory requirements aren't a checklist Qualigon maps to after the fact. They are the foundation the system was built on.

Regulatory alignment

Qualigon is designed for use in regulated life sciences environments and aligns with the core GMP frameworks across jurisdictions. This includes U.S. FDA regulations (21 CFR Parts 210 and 211), FDA guidance such as the Out-of-Specification (OOS) investigation framework, EU GMP (EudraLex Volume 4), and internationally harmonized ICH guidelines (Q7, Q8, Q9(R1), Q10). The system is built with these frameworks in mind, reflecting how deviation investigations are expected to be conducted, documented, and reviewed in practice.

Multi-jurisdictional support

Life sciences manufacturers often operate across multiple regulatory regimes simultaneously. Qualigon is designed to support this reality by encoding regulatory expectations across both U.S. and EU frameworks, with awareness of where requirements converge and where they differ. This allows investigation workflows and outputs to remain consistent with the stricter standard when operating globally.

Standards and reference frameworks

In addition to regulatory frameworks, Qualigon is informed by industry standards such as USP guidance, ISPE best practices, and established root cause analysis methodologies (including 5M/Ishikawa, 5 Whys, and FMEA). These are supported within the system but remain configurable to align with site-specific SOPs and practices.

AI integrity

Evidence-based outputs

All system outputs are grounded in traceable evidence. Qualigon does not generate unsupported conclusions — hypotheses and statements are only produced when backed by source material such as prior deviations, SOPs, or process data. Each output is explicitly linked to its underlying sources, enabling full traceability and audit defensibility.

No hallucinated responses

Qualigon is designed to avoid hallucinated or fabricated outputs. If sufficient evidence is not available to support a conclusion, the system will not produce one. This ensures that all outputs remain grounded, reviewable, and suitable for regulated environments where unsupported statements are unacceptable.

Auditability and data integrity

The system maintains a complete audit trail of inputs, retrieved evidence, generated outputs, and user interactions. This supports key data integrity principles (including ALCOA+) and ensures that investigation outputs are transparent, reviewable, and defensible during internal QA review or regulatory inspection.

Supported frameworks

FDA

21 CFR Part 11

FDA

21 CFR Part 210/211

FDA

21 CFR Part 600–680

FDA

21 CFR Part 820

FDA

OOS Guidance

EU / GMP

EU GMP

EU / GMP

GMP Annex 11

ICH

ICH Q7

ICH

ICH Q8 (R2)

ICH

ICH Q9 (R1)

ICH

ICH Q10

Industry

GAMP 5

Industry

ISO 9001

Industry

ISO 13485

Industry

USP Chapters

Configured to your SOPs and procedures

Beyond industry frameworks, Qualigon is configured against your site-specific SOPs, internal procedures, and quality standards — so the system reflects how your organisation investigates, not just how the regulation requires it.

Serious about compliance?

See how Qualigon encodes your regulatory obligations into every step of the investigation workflow.

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