Built for
pharmaceutical
compliance.

21 CFR Part 11ALCOA+EU Annex 11GxP

DEEPC is engineered from the ground up for regulatory compliance, with immutable audit trails , 7-year data retention , and complete traceability for pharmaceutical research.

Immutable Audit TrailsEvery action is timestamped, attributed, and cryptographically secured
ALCOA+ PrinciplesData integrity built on pharmaceutical industry standards
7-Year RetentionAutomated GxP-protected retention policies for regulatory compliance
Complete TraceabilityFull data lineage from source documents to final results

ALCOA+
principles.

Every principle is architecturally enforced at the platform level, not bolted on as an afterthought.

AttributableAll data is attributed to the individual who generated it, with user ID, username, and IP address captured in immutable audit logs.
LegibleData is stored in a structured database with human-readable fields, ensuring clarity and accessibility for regulatory review.
ContemporaneousServer-side timestamps ensure all records are created at the time of the action, preventing backdating or manipulation.
OriginalImmutable database records with SHA-256 integrity hashing ensure data cannot be altered after creation.
AccurateInput validation, data type constraints, and integrity verification ensure all data meets quality standards.
+CompleteComprehensive audit coverage of all critical operations, from user actions to system events.
+ConsistentStandardized event types and structured logging ensure uniform data capture across the entire platform.
+Enduring7-year audit log retention with GxP-protected storage ensures long-term data availability.
+AvailableRobust query methods and export capabilities provide on-demand access to audit data for regulatory inspections.

21 CFR Part
11 compliance.

§11.10(e)Immutable Audit TrailsTime-stamped audit logs for all operations with complete user attribution and IP tracking.
§11.10(c)7-Year Data RetentionAutomated GxP-protected retention policies ensure compliance with regulatory requirements.
§11.10(a)Tamper DetectionSHA-256 integrity hashing ensures data authenticity and detects any unauthorized modifications.
§11.10(d)User AuthenticationJWT tokens and API key authentication with multi-factor support for secure access control.
Data SovereigntyLogical Tenant IsolationStrict cryptographic segregation ensures proprietary molecules (NCEs) are processed in ephemeral instances with zero cross-tenant data interaction.
§11.10(a)Data Lineage TrackingComplete provenance tracking from source documents through analysis to final results.
§11.100Electronic SignaturesUnique user attribution with non-repudiation ensures accountability for all data changes.

EU Annex 11 Compatible: All features also support European Medicines Agency requirements for computerized systems in GxP environments.

GAMP 5
qualification.

Installation Qualification

Verify system installation and configuration meets specifications

Hardware and software configuration verification
System installation documentation and traceability
Environmental controls and security validation
Standard Operating Procedures (SOPs) establishment

Operational Qualification

Verify system operates correctly under normal conditions

Functional requirements and specifications testing
Data integrity controls and audit trail verification
User access management and role-based controls
Business process workflow validation

Performance Qualification

Verify system performs effectively in production environment

Real-world scenario and use case validation
System performance under operational conditions
User acceptance testing with end users
Continuous monitoring and periodic review protocols

Risk-Based Validation Approach

Our validation strategy follows a lifecycle approach aligned with GAMP 5 principles and 21 CFR Part 11 requirements. We employ risk-based methodologies to ensure data integrity, patient safety, and regulatory compliance.

Responsible
acceleration.

A carbon-neutral AI platform purpose-built for pharmaceutical formulation. We decouple drug development from physical waste, directly reducing Scope 3 emissions while accelerating market entry.

Performance highlights
Energy Source100% Renewable
Waste Reduction~98% vs Wet Lab
ComplianceCSRD Ready
Green InfrastructureComputation executed exclusively in carbon-free cloud regions (Google Cloud Iowa/Finland).
Carbon NeutralityScope 1 & 2 emissions fully offset via high-quality carbon removal (Biochar/Direct Air Capture).
In-Silico SubstitutionReplacing high-entropy physical screening with deterministic physics simulation.

Scope 3
reduction.

GHG ProtocolSBTi
0%
Total Pharma Emissions
Scope 3 (Cat 1)
50%
API Synthesis
25%

The “Physical” Footprint Problem

Purchased Goods & Services (Category 1) represent the lion's share of a pharmaceutical company's carbon footprint. This is driven largely by the high E-factor (waste-to-product ratio) of chemical synthesis during R&D and manufacturing.

The Computational Advantage: DeepCeutix eliminates the “trial-and-error” phase of formulation. Instead of physically synthesizing 500 candidate formulations, generating chemical waste for each failure, we simulate them. We only synthesize the winner.

Audit-Ready Data
Every simulation is logged with provenance data, supporting TCFD climate risk assessments and SBTi validation.
Impact
Demonstrable reduction in solvent usage and raw material procurement for R&D operations.

Process Mass Intensity (PMI)

Kg of Raw Material input per Kg of Product

Metric: Efficiency
<5
DeepC Design
182
Industry Avg

Source: ACS GCI Pharmaceutical Roundtable / DeepCeutix Benchmarks

Optimizing atom economy.

PMI is the gold standard metric for pharmaceutical sustainability. The industry average of 182 reflects the massive solvent use in traditional chemistry.

Our platform optimizes synthesis pathways for Atom Economy and Solvent Selection before a flask is ever touched. We guide chemists toward bio-based solvents and shorter, more convergent synthesis routes.

Integrated
governance & reporting.

Meeting evolving ESG disclosure requirements with built-in reporting frameworks and emissions tracking.

Mandatory Reporting (CSRD)

The EU Corporate Sustainability Reporting Directive is now active. FY2024 data must be reported in 2025. DeepCeutix ensures your R&D data is structured for automated compliance.

2024Data Collection PeriodTracking of all R&D inputs and computational offsets.
2025 DeadlineFirst Reports DueLarge enterprises must file CSRD reports for FY24.
2026+Scope ExpansionReporting requirements extend to listed SMEs.
Verified Alignment
SBTi
GHG Protocol
TCFD
CDP
EcoVadis
DJSI
Our promise

Net zero by design.

0
Full Value Chain Neutrality

We pledge to maintain 100% renewable energy usage for all inference and training workloads through 2030.

We commit to open-sourcing our "Green AI" efficiency kernels to help the broader industry reduce compute cost.

We will prioritize suppliers and partners who adhere to SBTi 1.5°C aligned targets.

Book a demo.

Tell us what you are working on (molecule, indication, stage, open question).

A formulation lead will be in touch within a business day.

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