Software Solutions

Stark Pharma Software Solutions

Transforming Compliance, Operations & Quality Through Smart Software

Stark Pharma’s suite of software products is purpose-built for the life sciences sector—enabling pharmaceutical and medical device manufacturers to streamline regulatory compliance, digitize operations, and enhance decision-making. Our platforms are developed with a deep understanding of global regulations like ISO 13485, 21 CFR Part 11, and EU Annex 11, ensuring audit-readiness, traceability, and process integrity.

Whether you're a startup scaling your GMP systems or an established enterprise optimizing your digital stack, our solutions provide the flexibility, security, and intelligence you need.

🛡QMS Compliance Suite:

Comprehensive eQMS for Regulated Industries

An intuitive, web-based Electronic Quality Management System (eQMS) that digitizes:

• Deviation Management & CAPA
• Document Control & Change Management
• Training Records & Role-Based Learning
• Audit Trail Management
• Risk & Compliance Dashboards

Designed to meet ISO 13485 and 21 CFR Part 11 compliance requirements, the QMS Suite offers configurable workflows, role-based access, and full validation support for regulatory inspections.

📊 PQC Report: Product Quality Complaints Intelligence at Your Fingertips

A cloud-native application that allows manufacturers to monitor, analyze, and report on shop-floor performance and batch-level quality metrics. PQC Report empowers quality teams with:

• Customizable Dashboards
• Automated Non-Conformance Alerts
• Visual Analytics for Root Cause Trends
• Data Export & Compliance Logging

Ideal for Quality Assurance (QA), Production, and Regulatory Affairs teams seeking real-time visibility and proactive control.

StarkERP: Integrated ERP for Life Sciences

StarkERP is an advanced Enterprise Resource Planning platform meticulously designed for the unique needs of pharmaceutical, biotechnology, and medical device companies. Built on industry-specific best practices and compliant with global regulatory frameworks, StarkERP enables seamless operations across your entire organization—from procurement and production to quality, finance, HR, and compliance.

Why StarkERP?

Traditional ERP systems often fall short in regulated environments. StarkERP closes that gap with:

• Modular Design: Start with what you need—scale as you grow. Modules include Inventory, Production, Finance, HR, Compliance, and more.
• Validation-Ready Framework: Fully compliant with 21 CFR Part 11, ISO 13485, and GMP standards.
• Cloud or On-Premise Deployment: Flexible hosting options to match your IT strategy and data security requirements.
• Real-Time Dashboards & Analytics: Gain actionable insights with intelligent reports, KPIs, and batch-level traceability.
• Quality & Compliance Integration: Integrates with our QMS Suite for deviations, CAPAs, and audit tracking in one ecosystem.
• Multi-site and Multi-country Support: Ideal for companies with global operations and distributed teams.

Core Modules:

• Inventory & Supply Chain
• Production & BMR/BPR Management
• Quality & Compliance
• Finance & Costing
• HR & Training Records
• CRM & Sales Order Management
• Procurement & Vendor Management

Built for Regulated Environments

Unlike generic ERPs, StarkERP is built with life sciences DNA—ensuring your digital workflows are inspection-ready, data-integrity compliant, and auditable at every step.

🔐 Built for Compliance & Scalability

All Stark Pharma software products are:

• Validation-Ready (IQ/OQ/PQ documentation available)
• Highly Configurable to client SOPs
• Cloud-Hosted with Enterprise Security
• Supported with Continuous Updates & SLA-Based Assistance

We ensure your systems grow as your business evolves—without compromising compliance or operational control.

Partner with Us

Want to digitize your pharmaceutical or device operations without the compliance headache?

Get in touch at: sales@starkpharma.com