Kea cGMP

Kea cGMP

The Intelligent Integrated Kea cGMP ERP solution That Turns Regulatory Excellence into Business Growth

In pharmaceutical manufacturing, quality isn't just about compliance—it's the foundation of everything. Your reputation, your market access, your competitive edge. Yet too many companies are held back by systems that treat quality as a checkbox rather than a strategic advantage.
Kea cGMP changes that equation. We've built the only pharmaceutical ERP solution that achieved
zero audit observations in actual regulatory audits—not once, but consistently across clients for over 13 years.
This isn't about managing consistency in compliance. It's about mastering it.

When Quality Systems Hold You Back
Every day without the right quality infrastructure costs you:
The Regulatory Burden: Manufacturing shutdowns draining costs monthly. Export certifications at constant risk. Warning letters that take years to overcome. Schedule M gaps that threaten your license to operate.
The Operational Drain: Quality teams spending 40% of their time on documentation instead of improvement. Deviation investigations stretching into weeks. APQR compilations consuming months. Critical insights buried in filing cabinets while decisions wait.
The Strategic Limitation: Unable to scale because your systems can't keep pace. Losing contracts to competitors with validated platforms. Innovation stalled by compliance overhead. Talent leaving for companies with modern tools.

The pharmaceutical companies winning today aren't working harder—they're working smarter with systems designed for excellence.
Built Different: Quality From the Ground Up
A Track Record That Speaks for Itself
Our Audit History:
• 2018: Ghana FDA audit – Zero observations
• 2022: USFDA audit – Zero observations
• 2023: ISO 9001:2015 organizational certification
• 100% audit success rate across every client site since 2011
When regulatory authorities audit facilities running Kea cGMP, they consistently find operations in exemplary compliance. That's not luck. That's design - QbD enabled ERP System in symphony with Regulatory requirements, Client Requirement and ultimately Patient Safety.

 

Six Capabilities That Redefine Pharmaceutical Operations

Engineered for compliance, integrity, efficiency, and long-term excellence.

01

Not appriopriate. You may try like Turn Audits into Operational Excellence

Instant document retrieval, tamper-proof audit trails, and built-in global GMP compliance transform inspections into confidence-building demonstrations.

  • Audit-ready visibility
  • Bulletproof documentation for export markets
  • Client audits build confidence
  • Management shifts from firefighting to strategy
02

Integrity Built Into Every Record

ALCOA+ enforced system-wide with real-time capture, version control, tamper-proof timestamps, and zero possibility of backdating.

  • Authenticated user actions
  • No manipulation or overwriting
  • Full audit trails for every event
  • Automated validation & cross-checks
03

User Adoption That Sustains Compliance

Intuitive multilingual UI, mobile access, and consistent workflows enable rapid adoption—even by non-technical users.

  • Minimal training required
  • Operators adapt immediately
  • Reduced IT dependency
  • Fast ROI due to instant adoption
04

One Platform, Infinite Possibilities

A unified ecosystem covering ERP, QMS, LIMS, and VQ—built around quality, scalability, and pharma-first architecture.

  • Seamless cross-module integration
  • No disconnected systems
  • Configurable workflows
  • Scales with regulations & growth
05

Inventory Intelligence That Optimizes Every Rupee “ or ‘Inventory That Thinks Ahead

Real-time stock visibility, batch-wise traceability, expiry control, and financial transparency eliminate losses and pilferage.

  • Real-time stock control
  • FIFO/FEFO enforcement
  • WIP & variance tracking
  • Zero tampering & full accountability
06

A Partnership That Understands Your World

Deep pharmaceutical domain expertise with continuous regulatory updates, optimization reviews, and proactive support.

  • Techno-functional pharma experts
  • Ground-reality driven implementations
  • Continuous improvement support
  • Industry-best practice alignment

Advanced Capabilities for Complex Requirements

GAMP 5 Validated Platform

Risk-based validation (IQ/OQ/PQ) with integrated change control ensuring robust compliance.

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AI-Powered Intelligence

Pattern recognition of systemic issues, CAPA prediction, and intelligent early warning systems.

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Kea CRMS (Beyond CRM)

Order tracking, contract manufacturing, and post-market surveillance including adverse events & recalls.

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Kea LIMS (Laboratory Excellence)

Sample management, instrument calibration, auto CoA generation, and analytics for OOS/OOT investigations.

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Kea SCM (Supply Chain Orchestration)

Multi-warehouse management, ABC analysis, JIT capabilities, and full-level serialization.

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Kea Stability Studies

ICH-compliant protocols, automated environmental monitoring, and statistical shelf-life analysis.

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Operational Excellence Delivered Daily

Transforming documentation, collaboration, efficiency, and security across the entire pharmaceutical value chain.

Documentation Revolution

Automated, context-based document generators produce all GMP documents instantly from validated system data. Formatting, version control, and archival are handled automatically—zero manual dependency.

Role-based access, electronic signatures, automatic removal of outdated documents, and instant audit retrieval complete the foundation of a digital-first documentation system.

Key Highlights

  • 1. Instant document generation
  • 2. Zero formatting inconsistencies
  • 3. Audit-ready structure
  • 4. Training-based access control

Efficiency That Compounds

System-driven workflows eliminate the possibility of skipping critical steps. Real-time departmental handoffs bring transparency and prevent bottlenecks.

QA, QC, and Production collaborate on a unified platform with instant visibility and parallel reviews to drastically reduce cycle time.

First-Year Results

  • Manufacturing cycle time: Reduced
  • Batch release time: Reduced
  • Documentation time: Realtime
  • Quality incidents: Reduced

Impact Highlights

  • 1. Unified platform for all departments
  • 2. Complete workflow automation
  • 3. Parallel review cycles
  • 4. Reduced manual intervention

Security Architecture

Granular access control and content-level security ensure your intellectual property remains protected. Automatic redaction hides sensitive content from unauthorized users.

Intelligent audit trails monitor all activity, detect unusual patterns, and provide early-warning for potential risks.

Security Highlights

  • 1. IP-level access restriction
  • 2. Content-based automated redaction
  • 3. Unauthorized access alerts
  • 4. Risk pattern recognition

Measurable Business Transformation

Time Liberation

Document prep, data reconciliation, APQR compilation — all in realtime.

Financial Impact

Guaranteed ROI, reduced inventory cost, minimized documentation cost.

Quality Elevation

Zero audit observations, reduced deviations, fewer rejections.

Human Capital Optimization

QA bandwidth increased, R&D accelerated, and higher team efficiency.

Why choose Kea cGMP over SAP or Oracle?

Generic ERPs require extensive customization for pharma compliance—taking years and costing crores. Kea cGMP is purpose-built for pharmaceutical operations with out-of-the-box cGMP compliance. Implementation is faster, cost is lower, and pharma-specific functionality is superior.

Audit Safety During Implementation

Your existing validated systems remain operational. Kea cGMP implementation does not affect audit readiness. Many clients have passed audits while implementation was ongoing.

The Choice Before You

  • Lead with Kea cGMP: Zero observation confidence.
  • 90% reduction in documentation effort.
  • Guaranteed data integrity protection.
  • Scale growth with validated systems.
  • Retain talent with modern technology.

  • Or Continue as You Are:
  • High regulatory risk.
  • 40% QA time wasted on manual work.
  • Weak data integrity controls.
  • Growth limitations due to system gaps.

Transform Your Quality System Today

Schedule your free compliance assessment.

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Our Trusted Clients

Frequently Asked Questions

How long does implementation take?
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Typical implementations range from one to two months depending on complexity and organizational readiness. Phased approaches starting with critical modules minimize disruption.

Will this disrupt production?
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No. We run parallel with existing systems until user acceptance complete and validation as per requirement. Go-live scheduling avoids any production shutdown.

What about validation?
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Complete validation documentation (URS, FRS, IQ/OQ/PQ, Validation Summary Report) is included as per Client requirement. Our pre-validated system significantly reduces validation effort and cost.

Can you handle our specific formulations?
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Yes. We support all dosage forms: tablets, capsules, liquids, injectables, ointments, APIs, medical devices, CRO/CDMO/CRDMO operations, R&D facilities, and testing laboratories. Customization available for unique requirements.

What's the total investment?
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Pricing depends on modules, users, and sites. Most clients achieve ROI within three to six months through efficiency gains and compliance risk reduction. Contact us for a customized proposal.

Do you provide training?
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Comprehensive training for all user levels is included—from shop floor operators to senior management as per their SOPs and with ongoing support.

How do you handle regulatory updates?
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We monitor global regulatory changes and update the system accordingly. Updates reach clients proactively. Your change control governs post-validation changes.

Can we start small?
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Absolutely. Our modular architecture lets you start with core ERP and add QMS, LIMS, or other modules as needed, reducing initial investment and implementation risk.

Testimonials