PharmaLIMS — Pharmaceutical Laboratory Information Management System

An enterprise-grade LIMS for GMP-compliant pharmaceutical testing laboratories: sample lifecycle management, drug assay, dissolution, stability, impurity, HPLC/GC and microbiology testing, batch release with CoA generation, QA (deviations, CAPA, change control), controlled documents, audit trail, analytics and an external client portal.

Tech stack

Layer	Technology
Frontend	Next.js 16 (App Router), React 19, TypeScript, Tailwind CSS 4
UI	Custom shadcn-style component library (components/ui), lucide-react icons
Charts	Recharts
Backend	Next.js server components + server actions (actions/)
Database	PostgreSQL (canonical) with Prisma ORM — SQLite for zero-setup local dev
Auth	JWT sessions (httpOnly cookies) + bcrypt password hashing + RBAC

Quick start (local demo, no external database required)

npm install
npm run db:local     # generates a SQLite schema variant, creates prisma/dev.db
npm run db:seed      # seeds roles, users, clients, samples, tests, QA records…
npm run dev          # http://localhost:3000

The seed creates six demo accounts. On the login page, click a role button to fill credentials, then sign in:

Role	Email	Password
Laboratory Administrator	[email protected]	Admin@123
Lab Manager	[email protected]	Manager@123
Quality Assurance Officer	[email protected]	Qa@123456
Chemist / Analyst	[email protected]	Analyst@123
Microbiology Analyst	[email protected]	Micro@123
Client / Pharma Company	[email protected]	Client@123

Production (PostgreSQL)

1. Point DATABASE_URL in .env to your PostgreSQL instance.
2. npx prisma generate && npx prisma db push
3. npm run db:seed && npm run build && npm start

prisma/schema.prisma is the canonical PostgreSQL schema; the schema is written provider-agnostically (no scalar arrays / native types) so the same models work on both engines.

Architecture

prisma/schema.prisma        Canonical relational model (25+ tables)
lib/roles.ts                Role & permission matrix, status metadata
lib/nav.ts                  Role-aware navigation tree
lib/session.ts              JWT session issue/verify + getCurrentUser()
lib/data.ts                 Dashboard aggregations (KPIs, charts)
lib/testing.ts              Test/stability queries
lib/prisma.ts               Prisma client singleton
lib/ids.ts                  Human-readable code generators (SPL-, TST-, RPT-…)
lib/audit.ts                Audit-trail writer
actions/*.ts                Server actions: auth, samples, tests, quality, portal
app/(auth)/login            Login screen
app/(dashboard)/            Back-office shell: dashboard, samples, testing/*,
                            quality/*, reports, documents, instruments,
                            clients, batch-release, audit-trail, admin
app/(client)/client         External client portal
components/ui               Design system (button, card, badge, table, forms…)
components/charts           Recharts visualisations
components/layout           Sidebar / topbar / shell

Data model highlights

• Samples carry barcode identifiers, storage conditions, chain-of-custody records and storage events across their lifecycle (RECEIVED → LOGGED → ASSIGNED → TESTING → REVIEW → APPROVED → RELEASED → ARCHIVED).
• Tests link to typed result tables (AssayResult, DissolutionResult, ImpurityResult, MicrobiologyResult) plus worksheet JSON and attachments.
• StabilityStudy / StabilityTimepoint model ICH protocols with scheduled pulls, due/overdue alerting.
• Quality modules cover Deviation, Capa, ChangeControl and generic Approval decisions.
• AuditLog records actor, action, entity, old/new values for every mutation.

Workflow enforcement

• Analysts submit results on a locked worksheet; OOS assay results automatically raise a deviation.
• QA approves from the review queue; approval generates a controlled report.
• Batch release requires every linked test to be approved before disposition.

Scripts

Command	Purpose
npm run db:local	Create/update the local SQLite dev database
npm run db:seed	Seed the demo dataset
npm run db:generate	Regenerate Prisma client (PostgreSQL)
npm run db:push	Push schema to PostgreSQL
npm run build	Production build

Security notes

• Sessions are signed JWTs in httpOnly, SameSite=Lax cookies with a TTL from SESSION_TTL_DAYS.
• Passwords hashed with bcrypt (cost 10).
• Every route group checks the session in its layout; role-gated navigation and permission checks are centralised in lib/roles.ts.
• Set a strong AUTH_SECRET in production.