Compliance & Governance

10-checkpoint compliance engine with full regulatory traceability

Every formulation passes through a rigorous, auditable compliance pipeline. Each checkpoint generates evidence, requires approval, and maintains a complete version history.

Compliance Pipeline — 10-Checkpoint Sequential Gate Model
FORMULATION INPUTIngredients + ConcentrationsREGULATORY CONTEXTTarget Markets + FrameworksAPPLICATION PROFILEProduct Type + Packaging + StorageSEQUENTIAL COMPLIANCE PIPELINECP1Reg StatusCP2Conc LimitsCP3AllergensCP4CLP/GHSCP5RestrictedCP6LabellingCP7StabilityCP8Cross-ContCP9Doc CheckCP10Market ClearHUMAN REVIEW & APPROVAL GATE✓ APPROVE✗ REJECT↻ REQUEST REVISIONRe-enter pipelineMARKET CLEAREDCompliance Report · TDS · SDSEvidence Package · Audit TrailREJECTEDRejection Reason · Failed CheckpointsMandatory Comment · LoggedAUDIT TRAILEvery decision immutably loggedTimestamp · User · Evidence · Outcome

Checkpoint Detail

CP1
Ingredient Regulatory Status
Validates each ingredient against FEMA GRAS, EU 1334/2008, JECFA, and jurisdiction-specific positive lists.
CP2
Concentration Limits
Checks ingredient concentrations against IFRA standards, FEMA usage levels, and application-specific limits.
CP3
Allergen Declaration
Identifies and flags declarable allergens per EU, FDA, and regional frameworks with labelling requirements.
CP4
CLP/GHS Classification
Assigns hazard classification, signal words, H-statements, and P-statements for the formulation.
CP5
Restricted Substance Screening
Screens against banned/restricted substance lists across target markets (EU, US, APAC, LATAM).
CP6
Labelling Requirements
Generates compliant ingredient declarations, allergen statements, and market-specific label elements.
CP7
Stability Risk Assessment
Evaluates formulation stability risk based on 18 rules, application profile, packaging, and storage conditions.
CP8
Cross-Contamination Risk
Assesses cross-contact allergen risk from shared production lines and co-manufacturing environments.
CP9
Documentation Completeness
Verifies all required documentation (TDS, SDS, CoA, specifications) is present and current.
CP10
Market Clearance
Final gate confirming formulation is cleared for each target market with all regulatory obligations met.

Approval Workflow

Live
✓Three-state review: Approve, Reject, Request Revision
✓Configurable approver roles per checkpoint
✓Mandatory comments on rejection with revision guidance
✓Sequential gate enforcement — no skipping checkpoints

Version History & Traceability

Live
✓Full formulation version history with diff tracking
✓Every ingredient change creates a new auditable version
✓Regulatory decision lineage — trace any output to its evidence
✓Immutable audit log — no retroactive edits to compliance records

Evidence Export

Live
✓Export compliance reports per formulation (PDF/JSON)
✓Checkpoint-level evidence packages for auditors
✓Regulatory summary documents (TDS, SDS generation)
✓Bulk export for regulatory submissions and inspections

Human Review Controls

Live
✓AI outputs are always human-reviewable before approval
✓Confidence indicators on AI-generated compliance assessments
✓Override capability with mandatory justification logging
✓Escalation paths for edge-case regulatory decisions

20+ Regulatory Frameworks

EU 1334/2008FEMA GRASJECFAIFRA StandardsEU CLP/GHSREACHFDA 21 CFRCodex AlimentariusJapan FFCRChina GB StandardsANVISA (Brazil)FSANZ (ANZ)KFDA (Korea)FSSAI (India)Health CanadaEU Allergen RegsCalifornia Prop 65ASEAN HarmonisationGulf Standards (GSO)Mercosur

See the compliance engine in action

Walk through a live compliance run on a real formulation — from ingredient validation to market clearance.