21 CFR 11
Electronic Records & Signatures
Full compliance with FDA requirements for electronic records, electronic signatures, and audit trail integrity in pharmaceutical systems.
Pharma-grade
security.
21 CFR Part 11EU Annex 11ISO 27001GDPRGAMP 5
DEEPC combines regulatory compliance , data sovereignty , and enterprise-grade trust to protect your most sensitive pharmaceutical research.
Zero-Trust ArchitectureEvery request is authenticated, authorised, and encrypted : no implicit trust, even inside the network perimeter.
Data SovereigntyRegional deployment options ensure your data never leaves the jurisdiction you specify.
Immutable Audit TrailsCryptographically signed, append-only logs for every action, decision, and data access event.
No Training on Your DataYour proprietary formulations and molecules are never used to train our models. Zero-knowledge guarantee.
Compliance
standards.
Built to meet the most demanding regulatory frameworks in pharmaceutical research, from FDA electronic records requirements to EU data protection law.
EU Annex 11
Computerised Systems
Aligned with EMA guidelines for computerised systems in GxP environments, covering validation, data storage, and access controls.
ALCOA+
Data Integrity Framework
Architecturally enforced ALCOA+ principles ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
GxP
Good Practice Compliance
Platform-wide adherence to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) requirements.
ICH Q9/Q10
Quality Risk Management
Integrated quality risk management and pharmaceutical quality system principles aligned with ICH guidelines for lifecycle-based approaches.
GDPR
Data Protection Regulation
Full compliance with the EU General Data Protection Regulation, including data minimisation, purpose limitation, and right to erasure.
Security
architecture.
Our security architecture follows a zero-trust model with defence in depth. Every layer : from network perimeter to application logic to data storage : is independently secured, monitored, and auditable. No single point of failure, no implicit trust.
Security stack
AES-256 Encryption
MFA + RBAC
24/7 SIEM
Encryption at RestAll data encrypted using AES-256 with customer-managed keys. Database-level encryption with automatic key rotation and hardware security module (HSM) key storage.
Encryption in TransitTLS 1.3 enforced on all connections. Certificate pinning for API communications. Perfect forward secrecy ensures past sessions remain secure.
Infrastructure SecurityHardened VPC architecture with private subnets, network segmentation, and 24/7 SIEM monitoring. Automated vulnerability scanning and intrusion detection.
Access ControlsRole-based access control (RBAC) with multi-factor authentication (MFA). Principle of least privilege enforced across all system components with session management.
Audit
trail.
AI Decision Audit Trail
Every AI prediction, recommendation, and model inference is logged with full input-output traceability. Inspect any decision and understand why it was made.
Immutable Logging
Cryptographically signed, append-only audit logs with SHA-256 integrity hashing. Logs cannot be altered, deleted, or backdated once written.
Formulation Version Control
Complete version history of every formulation, dataset, and analysis. Roll back to any point in time with full attribution and change documentation.
Regulatory Export
One-click generation of inspection-ready audit packages. Pre-formatted for FDA, EMA, and PMDA submission requirements with complete data lineage.
FDA Inspection Ready
Generate complete, inspection-ready audit packages with a single click. Pre-formatted for FDA, EMA, and PMDA submission requirements : including full data lineage, user attribution, and timestamp verification.
Privacy &
sovereignty.
Your data is yours. We enforce strict boundaries around how it is stored, processed, and accessed : with full transparency and control.
Data ResidencyChoose where your data lives. Regional deployment options ensure compliance with local data sovereignty laws and cross-border transfer restrictions.
Tenant IsolationStrict cryptographic segregation between tenants. Proprietary molecules and NCEs are processed in ephemeral instances with zero cross-tenant data interaction.
Retention & DeletionConfigurable retention policies aligned with GxP requirements. Automated 7-year retention for regulatory data with verifiable cryptographic deletion on request.
Data MinimisationWe collect only what is necessary for the service. No telemetry on proprietary formulation data. Purpose-limited processing with explicit consent controls.
Zero-Knowledge Guarantee
Your proprietary formulations, molecules, and research data are never used to train our models. Customer data is processed in isolated, ephemeral environments and is never aggregated, shared, or retained beyond the active session.
Certifications &
accreditations.
Independent verification of our security controls, processes, and compliance posture through recognised industry certifications.
In Progress
ISO 27001
Information security management system certification for systematic risk management.
Aligned
GAMP 5
Risk-based validation approach for computerised systems in GxP-regulated environments.
Aligned
ISO 27701
Privacy information management extending ISO 27001 with GDPR-specific privacy controls.
In Progress
Cyber Essentials Plus
UK government-backed certification for essential cyber security controls and external testing.
Aligned
CSA STAR
Cloud Security Alliance assessment for transparency in cloud security practices and controls.
All certifications subject to annual verification and continuous monitoring
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.