FDA Compliant Systems &
Lab LIMS Customization
Deploy 21 CFR Part 11 compliant audit ledgers, connect laboratory LIMS networks, and implement cold-chain thermal sensor trackers.
Securing Diagnostics with Validated Code
Syntrix Systems designs high-durability pharmaceutical software frameworks. We solve data compliance gaps and batch validation delays by streaming laboratory measurements and logistics parameters into append-only time-series databases. Our architectures maintain absolute security, role credentials, and auditable transaction transparency.
From electronic case records to cold-chain GPS alarms and LIMS script integrations, we deliver regulatory-compliant technology.
Industry Capabilities
Tailored engineering services to optimize operational metrics and integrate shop-floor OT with IT systems.
● LIMS & Lab Automation
Re-engineer and customize Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELN) for automated sample logging.
OT-IT Integration Architecture
Select a pipeline layer to inspect how field signals are funneled to enterprise systems.
LIMS & Lab Layer (Layer 1)
Instrumentation adapters, cold-chain trackers, and databases managing laboratory results securely.
Evaluate Your Efficiency ROI
Estimate the administrative days saved and quality auditing hours restored by implementing our automated compliance ledgers. Slide the settings to estimate real-time efficiency savings by integrating telemetry protocols.
Batch Compliance ROI Calculator
Deploying the Framework
A structured, phase-based implementation pipeline ensuring safety and seamless OT-to-IT connectivity.
Compliance & Scope Audit
Outline CFR Part 11 boundaries, document flow permissions, MFA layouts, and encryption tables.
LIMS & Lab Connection
Configure secure integrations to laboratory instrument adaptors and local telemetry databases.
Auditing & Ledger Setup
Deploy append-only audit trail databases and configure HSM-backed key decryption rules.
Dashboard & eCRF Launch
Build Next.js auditor portals, researcher dashboards, and mobile patient registries.
IQ/OQ/PQ Validation & Release
Complete rigorous Installation, Operational, and Performance Qualification testing protocols before rollout.
Client Solutions In Action
CFR Compliance Modernization at BioVance Labs
Syntrix deployed a 21 CFR Part 11 compliant audit trail ledger and Next.js auditor dashboard over BioVance's legacy LIMS databases, reducing batch release friction.
Technical FAQs
Answers regarding security standards, system integrations, and rollout scheduling details.
Ready to streamline your
Pharmaceutical Compliance?
Unify your lab metrics, reduce batch validation delays, and secure your audit trails. Contact our pharmaceutical systems team today.