EUROPEAN REGULATORY TECHNOLOGY

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Compliance. Engineered.

Technology infrastructure for organizations operating in highly regulated industries.

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OUR ENTERPRISE PRODUCTS
VERITAS • EQMS 21 CFR Part 11

Intelligent Quality Management

Automated GxP compliance controls, document lifecycles, and cryptographic PKI audit ledgers.

98.4% Compliance Health Index
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GENESIS • TRACEABILITY EU Annex 11

Regulated Production & Traceability

Complete supply chain lineage from raw material precursor to Qualified Person release.

< 3 Sec Recall Execution Speed
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NEXUS • LIMS ISO/IEC 17025

Laboratory Information Management

Direct instrument telemetry sync, automated OOS checks, and instant CoA issuance.

100% Automated CoA Issuance
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GENESIS Regulated Production & Traceability
BATCH #PH-8842-A
Production Lineage & Batch Genealogy
Raw Active Precursor Lot #RM-90412 Purity: 99.85% • Certified Ingredient
Formulation & Emulsification Cleanroom A2 • Temp: 18.4°C
Aseptic Fill & Serialization EU GMP Validated • 14,200 Vials
Chain of Custody
Cryptographic Hash 0x9f84...a429
EU GMP Annex 11 Verified Compliant
Serial Allocation EU-GS1-98402
VERITAS Intelligent Quality Management
21 CFR Part 11 Validated
Compliance Health Index
98.4 %
1,482 Automated Controls Active
Document Lifecycle • SOP-QA-2026-089
✓
Quality Assurance Review Approved by Dr. M. Weber • 09:14 CEST
✓
Regulatory Affairs Sign-Off Approved by H. Vance • 10:42 CEST
Qualified Person (QP) Release Authorization Pending Electronic Signature • PKI Verified
Change Control & CAPA Engine
0 Open Critical Deviations
12 Closed CAPAs (Q3)
< 24h Avg Resolution Time
NEXUS Laboratory Information Management
ISO/IEC 17025 ACCREDITED
Sample Queue
QC-90412-A Active Precursor Assay CoA Verified
QC-90412-B Heavy Metals HPLC Running Assay
QC-90413-A Microbial Bioburden Incubation (24h)
Certificate of Analysis #CoA-2026-8891
Parameter Specification Result Status
Potency Assay 99.0% – 101.0% 99.85% PASS
Residual Solvents < 50 ppm 1.2 ppm PASS
Endotoxin < 0.25 EU/mL < 0.05 EU/mL PASS
VERITAS • INTELLIGENT QUALITY MANAGEMENT

Quality without compromise.

Automated compliance controls, document lifecycles, and 21 CFR Part 11 electronic signatures engineered for European GxP and ISO regulated enterprise operations.

Veritas EQMS — Automated Release Authorization & PKI Audit Ledger
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SOP-QA-4092 • Version 4.2

Automated Batch Release Authorization Protocol

Effective Date: 2026-07-01 • Owner: Dr. M. Weber, VP Quality

This protocol specifies the automated controls required prior to final Qualified Person (QP) release under EU Regulation No 910/2014 (eIDAS) and FDA 21 CFR Part 11.

AUTHORIZATION STATUS Pending QP Electronic Signature
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Audit Ledger Telemetry
13:12:04 PKI Certificate validated for User #8941
13:08:19 CAPA-2026-104 linked to SOP-QA-4092
12:45:00 Automated Hash Verification: 0x9f8...a42
GENESIS • REGULATED PRODUCTION & TRACEABILITY

Complete traceability from origin to outcome.

A living production genealogy platform connecting raw materials, batch formulation, cleanroom environmental telemetry, and pharmaceutical distribution in seconds.

Genesis — Living Production Graph & Batch Lineage
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PRECURSOR MATERIAL
Active Precursor Lot #PR-7740

Pharma Ingredients AG • Basle, CH

CoA Verified ✓
→
MANUFACTURING BATCH
Batch #PH-8842-A

Cleanroom A2 • 14,200 Vials

In-Process Controls PASSED
→
SERIALIZED DISTRIBUTION
Frankfurt Logistics Hub

Cold Chain Monitored (2°C – 8°C)

GS1 Serialized ✓
Recall Execution Speed < 3 Seconds
Chain of Custody Integrity 100% Cryptographic Verification
Variance Tolerance 0.00% Unaccounted Material
NEXUS • LABORATORY INFORMATION MANAGEMENT

Every sample has a story.

Direct instrument telemetry integration, automated Out-of-Specification (OOS) checks, and instant Certificate of Analysis generation for analytical laboratories.

Nexus — Laboratory Instrument Telemetry & LIMS
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Sample Lifecycle Registry
1. Barcode Logging & Accessioning
2. Instrument Assay Execution
3. Automated OOS Threshold Check
4. CoA Generation & Direct LIMS Sync
Active Instrument Feeds
Agilent HPLC-1290 #01 Running Assay • Potency
Thermo ICP-MS #03 Calibration Valid • Ready
Shimadzu GC-MS #02 Assay Complete #RM-90412
PLATFORM ARCHITECTURE

Everything connected. Everything accountable.

Simpleafied Intelligence operates as a unified compliance graph engine linking regulations, operational processes, master documents, personnel, samples, products, and evidence.

Unified Compliance Graph

Dynamic cross-linking between regulatory standard changes, master document revisions, batch records, and lab testing certificates.

21 CFR Part 11 & EU Annex 11

Native cryptographic audit trailing, double-blind signoffs, and role-based access control built for European GxP mandates.

European Data Sovereignty

100% EU-hosted cloud infrastructure featuring end-to-end data encryption and ISO 27001 security certification.

REGULATED INDUSTRIES

Engineered for mission-critical operations.

Simpleafied provides purpose-built software infrastructure tailored to strict European regulatory frameworks.

IND • 01

Life Sciences

Comprehensive quality management for biotechnology innovation and medical device regulatory filings.

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IND • 02

Biotechnology

Cell and gene therapy sample tracking, environmental monitoring, and cold chain batch verification.

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IND • 03

Pharmaceutical Manufacturing

EU GMP Annex 1, Annex 11, and Annex 16 QP release automation with full batch lineage integrity.

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IND • 04

Testing Laboratories

ISO/IEC 17025 accredited laboratory information management, automated instrument sync, and CoA generation.

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IND • 05

Medical Cannabis

EU GMSP and GACP certified supply chain traceability, potency testing verification, and export compliance.

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IND • 06

Advanced Manufacturing

High-precision ISO 9001 and AS9100 quality control for specialty chemical and materials production.

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Build the foundation of trust.

Whether you manage quality, laboratories, or regulated production, Simpleafied provides the infrastructure to scale with confidence.

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