Enlight TEK SolutionsEnlight TEK Solutions
Pharma

Pharma Compliance & Batch Management Software Built for Zero Errors.

100%

21 CFR Part 11 Audit

Zero

Batch Recall Risk

FEFO

Automated Expiry Rule

Sub-Sec

Barcode Traceability

Custom Pharma Systems We Engineer

Electronic Batch Records (eBR)

Digitized batch manufacturing logs with immutable electronic signature sign-off.

Immutable audit trail • E-signature sign-off • Real-time batch status

Quality Control & Compliance

Automated sample testing workflows, deviation logs, and audit-ready PDF generation.

Deviation logging • Sample test checklist • Audit-ready PDF export

Distributor Order & Expiry Portal

Self-service ordering for distributors with automated expiry and FEFO stock management.

FEFO inventory rule • Expiry alerts • Bulk order processing

Serialisation & Track & Trace

Unique barcode serialisation tracking medicine boxes from plant to distributor.

Barcode serialisation • Anti-counterfeit check • Warehouse dispatch
Pharma

Operational Bottlenecks We Eliminate

  • ✓Batch manufacturing records sit in manual paper logbooks, complicating audit compliance.
  • ✓Expiry dates and inventory turnover are hard to monitor across regional distributors.
  • ✓Quality assurance approvals take days due to physical signature movement.
  • ✓Counterfeit and unverified stock risks damage brand reputation.

Specialized Pharma Sub-Sectors

Formulation Manufacturers

Electronic batch manufacturing logs and QA release sign-offs.

Bulk API Producers

Chemical raw material tracking and regulatory export logs.

Pharma Distributors

FEFO inventory management, credit terms, and order portals.

Contract Research (CRO)

Trial data collection, patient log security, and audit trails.

Technology Infrastructure

Python
Python
QA Engine
PostgreSQL
PostgreSQL
Audit Storage
Node.js
Node.js
Order API
Docker
Docker
Deployment
AWS
AWS
Cloud Hosting
TypeScript
TypeScript
Language

Security & Compliance

  • ✓21 CFR Part 11 E-Signatures
  • ✓GMP Audit Trail Logging
  • ✓Encrypted Chemical Data Vault
  • ✓FDA / Regulatory Ready Exports

Industry FAQs