BioLIMS — Compliance-First Laboratory Platform

Our Philosophy

At BioLIMS Inc., we believe compliance is not a checkbox — it's a culture.

Our platform is purpose-built for regulated research, diagnostics, and advanced biomanufacturing, enabling scientists and quality teams to operate with confidence, transparency, and control across every stage of discovery and production.

BioLIMS delivers more than compliance — it delivers audit intelligence, security automation, and regulatory resilience in a single, cloud-validated LIMS platform.

🔒 Comprehensive Compliance & Governance Framework

BioLIMS integrates global regulatory standards, ensuring readiness for the world's most demanding scientific and quality environments.

FDA 21 CFR Part 11 & EU Annex 11 Compliance

Complete support for electronic records and electronic signatures (e-Signature, e-Record, dual authentication, reason-for-change, and audit justification). Automatically validates and time-stamps all GxP data entries and approvals.

Full GxP / GLP / GMP / GDP Alignment

From preclinical research to commercial manufacturing, BioLIMS provides configurable templates for batch records, QC testing, equipment qualification, reagent tracking, and calibration workflows.

ISO 9001 & ISO 27001 Validation

Developed under certified quality and information security management systems — ensuring traceability, process control, and risk mitigation across the entire software lifecycle (SDLC).

HIPAA, GDPR, and CCPA Readiness

Personal and health data protection meets both U.S. and international privacy frameworks with customizable data retention and anonymization controls.

SOC 2 Type II & Cloud Infrastructure Aligned

BioLIMS operates on audited, validated infrastructure meeting industry-leading availability and integrity benchmarks.

🧾 Advanced Auditability & Data Integrity

BioLIMS provides multi-layered traceability that exceeds standard audit trail expectations — built to support FDA, EMA, and ISO inspections with minimal user effort.

Key Features:

• Immutable Audit Trail System — Append-only logs capture every action, user, and time event

• Contextual Change Tracking — Record relationships automatically update with full lineage visibility

• Dynamic Data Provenance — Trace results back to instruments, samples, operators, and software versions in seconds

• Real-Time Audit Dashboard — Proactive compliance monitoring and deviation alerts for QA oversight

• Automated Certification Reports — Generate validated audit summaries, e-record exports, and CFR 11 reports instantly

BioLIMS ensures data integrity by design — ALCOA+ compliant (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, and Enduring).

🧠 Enterprise-Grade Security Architecture

Security in BioLIMS is continuous, not static — monitored, encrypted, verified.

Security Layers:

• Encryption Everywhere — TLS 1.3 for data in transit, AES-256 for data at rest, with field-level encryption for sensitive metadata

• Zero-Trust Architecture — Granular access control, MFA, and adaptive authentication to eliminate lateral movement risks

• Continuous Threat Monitoring — 24/7 SIEM and anomaly detection integrated with cloud-native monitoring systems

• Regular Penetration Testing & Security Audits — Conducted by third-party cybersecurity firms

• Disaster Recovery & Redundancy — Multi-region failover, automatic backups

• Data Sovereignty & Encryption Key Ownership — Customers can manage their own encryption keys under BYOK / HYOK models

⚙️ Validation, Quality, and Change Management

Regulated environments demand validated software — BioLIMS makes that simple, scalable, and documented.

Validation Capabilities:

• IQ / OQ / PQ Packages — Full validation kits including test cases, scripts, and traceability matrices

• Automated Validation Testing — Built-in validation engine for post-upgrade verification

• Electronic Change Control — Integrated workflow for impact analysis, approval routing, and version locking

• Audit-Ready Documentation Library — Automatically generated SOPs, URS, and configuration records

• 21 CFR Part 820 (QSR) & ISO 13485 Ready — Ideal for regulated medical device and diagnostic labs

🧬 Regulatory Intelligence & Submission Support

BioLIMS goes beyond compliance — it simplifies regulatory reporting and submission readiness.

Regulatory Features:

• Regulatory Templates Library — Prebuilt submission templates for FDA, EMA, MHRA, and Health Canada

• Electronic Batch Record (eBR) & eDHR — Paperless manufacturing and device history records with full traceability

• Automated Quality Event Management — CAPA, deviation, and nonconformance tracking with root-cause analysis

• Controlled Vocabulary & Ontology Mapping — Ensures data consistency and semantic alignment across global sites

• Real-Time KPI Dashboards for QA/QP Review — Visual insights into quality performance and compliance metrics

🌐 Global Deployment with Local Control

BioLIMS empowers global life science organizations with flexible, compliant deployment options.

• Multi-region data residency in the U.S., EU, and APAC

• Cloud, private cloud, or on-premises installation options

• Configurable regional regulatory frameworks (FDA, EMA, CFDA, PMDA)

• Multi-site support with unified audit governance

🧩 Integration & Automation for Modern Compliance

• Native integration with ELNs, ERP, MES, and QMS systems (SAP, Oracle, Salesforce, MasterControl)

• API-based architecture enabling secure interoperability with instruments and analytical systems

• Automated deviation alerts, validation reminders, and compliance KPIs delivered via dashboards or email

• AI-driven anomaly detection to flag data outliers and compliance risks in real time

✅ Our Commitment

"For BioLIMS Inc., compliance isn't an obligation — it's our operating principle."

We are committed to:

• Proven regulatory readiness

• Continuous security validation

• Global data protection excellence

• Transparent auditability at scale

The BioLIMS Advantage

From clinical trials to cell & gene manufacturing, BioLIMS is your trusted compliance backbone — ensuring your science stands up to every standard, every time.