Your Trusted Partner In Delivering Software Validation Solutions

Our scalable, flexible, and transparent support helps you focus on your goals, while we ensure software validation becomes an integral part of your workflow.

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Validation You Can Trust. Partnership You Can Count On.

GMP Navigator specializes in delivering end-to-end software validation services for regulated industries. We help businesses ensure that their software systems work exactly as intended. Through Computer System Validation (CSV), we make sure your software solution is reliable, secure, and fully compliant with industry standards like FDA 21 CFR Part 11, GAMP 5, ISO, EU Annex 11, and FSMA. Our risk-based , audit-ready approach, helps your business implement and maintain compliant, reliable, and secure software systems.

Our scalable, flexible, and transparent support helps you focus on your goals, while we ensure software validation becomes an integral part of your workflow.

We serve the Life Sciences, Medical Devices, Nutraceutical, and Food & Beverage sectors, delivering tailored validation solutions backed by deep regulatory and ERP software expertise, along with regulated industry domain knowledge. This makes us your perfect partner to ensure that your ERP, QMS, WMS, MES, and other software systems meet regulatory requirements and comply with global standards.

Why Validation Matters?

Validation is not optional — it's critical for delivering safe products, maintaining compliance in regulated environments. It matters because it:

  • Ensures systems are compliant, reliable, and secure.
  • Confirms software performs as intended and meets the obligatory regulatory requirements.
  • Ensures product Quality & patient Safety through consistent, accurate, and traceable results.
  • Supports data integrity and trustworthy records.
  • Audit Readiness by providing documented evidence to meet inspection requirements.
  • Risk based validation approach minimizes chance of non-compliance, recalls, and penalties.
  • Improves operational efficiency and enables business continuity.

Services We Offer

Our flexible engagement models are designed for businesses of all sizes.

Complete ERP Software Validation

Complete end-to-end ERP Software Validation

Validation Toolkit

Ready-to-use templates aligned with norms like FDA & GAMP 5

Complete QMS Validation Services

Complete end-to-end QMS validation service

Validation-as-a-Service (VaaS)

Ongoing validation & monitoring for contract-period

Gap Assessments & Training

Identify gaps, train your team, and always stay compliant

Industries We Cater

We bring comprehensive validation expertise to every project. Our priority is to help you meet regulatory requirements seamlessly, without disrupting your operations.

Pharmaceuticals

We address the critical software validation needs of pharmaceutical manufacturing of products such as tablets, capsules, APIs, and injectables.
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Biotechnology

We support software validation used for complex therapies such as cell & gene treatments, monoclonal antibodies, and recombinant proteins.
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Medical Devices

Validation of software workflows for manufacturing of implants, infusion pumps, and monitoring devices.
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Personal Health Care Industry

Our validation support for creams, serums, shampoos, lotions, and color cosmetics ensures consistent quality and compliance.
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Nutraceuticals

Software validation ensuring compliance in the manufacturing of vitamins, probiotics, herbal extracts, and dietary supplements.
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Food & Beverage

We validate software to ensure compliance with industry requirements for packaged foods, dairy products, frozen meals, beverages, and more.
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Why Choose GMP Navigator?

Because with GMP Navigator, validation is done right.

  • End-to-End Validation - Comprehensive support from User Requirements (URS) to Final Validation Reports.
  • Multi-System Expertise - Proven experience with ERP, QMS, WMS, MES, and other critical systems.
  • Global Regulatory Compliance - Alignment with FDA, GAMP 5, 21 CFR Part 11, Part 210/211, Part 820, FSMA, and more.
  • GAMP 5-Compliant Documentation - Risk-based, audit-ready documentation that meets industry standards.
  • Flexible Engagement Models - Choose from Validation Toolkit, Complete Software Validation, Validation-as-a-Service (VaaS), Gap Assessments, and Training.
  • Experienced Cross-Functional Team - Deep domain knowledge in regulations, ERP systems, and industry processes.
  • Reliable, On-Time Delivery - Projects completed on schedule and within budget, every time.

The Approach We Follow -

GMP Navigator applies a risk-based, GAMP 5-compliant methodology customized to your system and regulatory landscape. Our approach ensures efficient validation, reduced compliance risks, and full alignment with global quality standards.

How We Do It

Step 1 : Deployment Models

We support validation for both on-premises systems and Cloud/SaaS Platforms. 

Step 2 : GAMP Category Assessment

System classification and risk assessment as per GAMP 5 guidelines. 

Step 3 : Core Deliverables
  • Validation Master Plan (VMP) 
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • Risk Assessment
  • IQ/OQ/PQ Protocols & Reports 
  • Traceability Matrix
  • Final Summary Report 
Step 4 : System Configuration & Security

Validation of system setup, access controls, user roles, audit trails, and e-signatures to ensure data integrity. 

Step 5 : Business Continuity & Disaster Recovery

Backup, restore, and recovery plan validation. Verification of policies and test strategies as outlined in the VMP.