Regulatory Compliance
Built in conformance with FDA Title 21 CFR Part 11, FALCPA, EU GMP Annex 11, and ICH Q8 guidelines
Canva for Compliance: Simplifying GxP audits and validation
Traditional pharmaceutical compliance software is like AutoCAD—over-engineered, desk-bound, and requires complex setup. PharmNode Studio is the Canva for compliance officers. Manage safety thresholds, trace changes, generate GxP reports, and verify chemical regulations directly in your browser.
GMP-Compliant Validation & Quality by Design
The compliance engine evaluates formulation safety thresholds in real-time. It records electronic logs (FDA Part 11), screens allergen indicators (FALCPA), maps pharmaceutical Design Spaces (ICH Q8), and generates print-ready specifications matching eCTD Module 3 dossier chapters.
1. FDA 21 CFR Part 11 & EU GMP Annex 11
PharmNode is built to guarantee absolute data integrity. Every action taken on the canvas—including ingredient concentration modifications, node connection routing, and PDF exports—triggers a cryptographically logged, immutable database audit entry. Features include secure, timestamps-tracked audit trails and digital validator signatures to satisfy CDMO tech-transfer inspections.
2. FALCPA & EU FIC 1169/2011 Compliance
Our database tags allergens (milk/lactose, wheat/gluten, soy, peanuts, etc.) automatically. Under the Food Allergen Labeling and Consumer Protection Act (FALCPA) and EU Regulation 1169/2011, incorporating an allergen-bearing excipient (like lactose) triggers immediate warnings and populates mandatory labeling disclaimers ('Contains...') on the output sheet.
3. ICH Q8 (R2) Quality by Design (QbD)
Traditional systems check parameters after physical tests. PharmNode implements Quality by Computational Design (QbCD) on the canvas. The engine defines a virtual 'Design Space' by checking ingredient interactions and compaction boundaries, preventing Critical Quality Attributes (CQAs) failure before cleanroom entrance.
4. eCTD Dossier Module 3 Format Readiness
Our PDF report generation module conforms with the standard Common Technical Document (eCTD) Module 3 structure (Quality/Chemical-Pharmaceutical data). Exported specifications, flowability parameters, and compatibility logs are organized in technical sections, saving days of manual translation for CDMO technology transfer.
Regulatory Standards Overview
Summary of regulatory environments integrated into the PharmNode DSS engine
| Standard Name | Regulatory Scope | PharmNode Implementation | Compliance Status |
|---|---|---|---|
| FDA 21 CFR Part 11 | Electronic Records & Signatures | Immutable GxP audit logging & signature workflows | Audit Ready |
| EU GMP Annex 11 | EU Computerized Systems Compliance | Data integrity validation and audit-ready lifecycle logging | Compliant |
| ICH Guideline Q8 (R2) | Pharmaceutical Quality by Design (QbD) | Volumetric Design Space calculations & CQAs check | Compliant |
| FALCPA 2004 | Supplement Allergen Labeling (US) | Auto allergen scanning & contains warnings | Compliant |
| EFSA Regulation 1169/2011 | EU Food Info & Allergens | Metric parameters & mandatory EU declarations | Compliant |
| eCTD Module 3 | Common Technical Document Structure | PDF exports organized by standard technical chapters | Ready |
Start Designing Compliant Formulations Today
Ensure full data integrity, GxP trace audit trails, and chemical safety rules from the first sketch.
Launch ConfiguratorHobby tier includes basic compatibility. Professional tier features full 35-class chemical checks and GxP reports.