End-to-End Security & Compliance for Bioinformatics Workflows
Protect sensitive biological data and streamline regulatory readiness with built-in governance, auditability, and advanced security features.
Data Security Meets Scientific Rigor
With increasing reliance on cloud-based bioinformatics and automation, maintaining data integrity and meeting regulatory requirements has never been more critical. Bioinformatics Digital’s Regulatory Compliance & Security Systems empower life sciences laboratories and research environments with integrated tools for digital security, traceability, and global compliance.
Whether handling protected health information (PHI), sequencing data, or clinical trial outputs, our platform ensures data governance aligned with HIPAA, GDPR, 21 CFR Part 11, ISO, and GxP frameworks.
Core Components
Hardware
Elastic Compute Servers
Rack-mounted or virtualized compute appliances optimized for genomics workflows like alignment, variant calling, and ML-based annotation.
Object Storage Arrays
High-throughput, parallel-access storage units for genomic data lakes (FASTQ, BAM, VCF), supporting tiered or hybrid cloud models.
Software
Audit Trail Engines
Log user actions, data changes, and system operations
Compliance Management Dashboard
Real-time compliance status monitoring, alerts, and rule-setting
eSignature & Validation Tools
Digital approval workflows and identity verification
Integrations
Compatible with LIMS, ELN, and Cloud Bioinformatics Platforms
Integrates with cloud service providers (AWS, Azure, GCP) with compliance-ready configurations
Links to document repositories, laboratory automation systems, and secure health information exchanges (HIEs)
Cloud
- Encrypted Cloud Storage – HIPAA and GDPR-compliant storage with configurable retention
- Access Control Systems – Cloud-based identity and role management (SSO, LDAP, OAuth2)
- Data Residency & Localization Tools – Ensure data storage within region-specific jurisdictions
Key Features
- Role-Based Access Control (RBAC) with multi-tier permissions
- Immutable, time-stamped audit trails for every transaction
- eSignature integration with support for Part 11 and EU Annex 11
- Multi-Factor Authentication (MFA) and federated identity login
- Real-time alerts for non-compliance or unusual activity
- Secure data export and reporting tools for regulatory bodies
Benefits
Reduces risk of data breaches and non-compliance penalties
Speeds up regulatory audits with organized, validated records
Enhances trust when collaborating with CROs, clinical partners, or regulatory bodies
Enables compliant scalability for growing multi-omics and clinical workflows
Applications & Use Cases
- Clinical genomics labs managing patient sequencing data
- Research institutions operating under government or grant regulations
- Biotech companies running FDA or EMA-compliant workflows
- Pharmaceutical manufacturing environments requiring GxP adherence
Industry Standards Supported
- HIPAA (Health Insurance Portability and Accountability Act)
- GDPR (General Data Protection Regulation)
- 21 CFR Part 11 (FDA Electronic Records & Signatures)
- ISO/IEC 27001, ISO 13485, and ISO 15189
- GAMP 5, GxP, and OECD GLP
Case Studies
Precision Genomics Center – Boston, MA
Integrated end-to-end data compliance for clinical trial workflows using RBAC and FDA Part 11 audit logging.
Oncology Data Lab – Toronto, ON
Deployed encrypted cloud infrastructure and biometric access terminals for handling sensitive PHI in cancer research.
BioTech CRO – San Diego, CA
Used centralized compliance dashboard to manage GxP compliance across global research sites and remote teams.
Digitize Your Lab with Built-In Trust
From electronic signatures to audit-ready data pipelines, our platforms embed compliance at the core. Talk to our digital compliance experts today and protect your lab’s future.
