Services
At GMP Navigator, we don’t just “check the box” to see if your software works. We make software validation clear, practical, and flexible — so you can achieve compliance without slowing down your business.
we offer flexible options and engagement models which allows you to Choose the engagement model that fits your needs. Whether you want us to manage the entire process, support your in-house team with toolkits, or provide ongoing compliance as a service, we’ve got you covered.
GMP Navigator Engagement Models
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
GMP Navigator Engagement Models
With our ERP Software validation service, you don’t have to worry about compliance complexities. We handle every Computer System Validation (CSV) deliverable from start to finish — making sure your ERP system is fully validated, audit-ready, and compliant. You get:
1. End-to-end validation: from User Requirement Specifications (URS) to final reports
2. Risk-based documentation aligned with FDA, EMA, FSMA, ISO, and GAMP 5
3. Proven validation practices for documentation, testing, and reporting
4. Audit-ready evidence at every stage
5. Expert-led, on-time, and cost-controlled delivery
This service is great for Companies that want expert-driven ERP software validation without worrying about compliance gaps or regulatory risks.
Our QMS validation service ensures that your Quality Management System stands strong during audits and inspections. We manage the entire validation cycle, making sure every deliverable is clear, compliant, and in line with your industry-specific regulations.
You get:
1. Coverage across the full validation cycle from planning, testing to final reporting
2. Clear, consistent documentation ready for regulatory review
3. Compliance with ISO standards, FDA 21 CFR Part 11, and GAMP 5 principles
4. Expert guidance on traceability, testing, and risk management
5. Reliable, on-budget project execution
It is best for companies that want their QMS validation managed by experts, ensuring complete compliance without extra burden on their teams.
Our Toolkit has ready-to-use, regulatory-compliant templates that follow FDA and GAMP 5 guidelines.
You get easy-to-edit Word and Excel templates so you can:
1. Create documents quickly and effortlessly
2. Use formats for requirements, testing, traceability, and more. These also include formats for URS, FRS, IQ/OQ/PQ, traceability matrices, and more.
3. Change the templates to fit your own process, and don’t have to start from the ground up.
4. Consistency and clarity across all documentation
This option is perfect for companies that prefer a hands-on approach but want to save time and ensure compliance
If your company wants ongoing compliance without hiring more staff and paying high end salaries, GMP Navigator VaaS is the right fit for you. With regular support, it manages reviews, revalidations, and updates to keep your systems compliant.
VaaS includes:
1. A smart, risk-based way to validate in budget.
2. Coverage for cloud/SaaS and on-premises systems
3. GAMP 5–aligned documentation
4. Regular compliance checks and revalidations
This is great choice for businesses shifting from manual systems to digital/cloud platforms or those needing reliable long-term compliance support.
If you already have a validated system but unsure if you’re fully compliant? We identify gaps, fix risks, and train your team for stronger control.
You get:
1. Full gap analysis & compliance roadmap
2. Corrective action plans
3. Hands-on training: CSV principles, regulatory rules, best practices
This is best for companies that aim to boost compliance readiness while empowering internal teams.
Key Benefits of Validation Services by GMP Navigator
- The GMP Navigator team brings extensive expertise in ERP systems, including BatchMaster ERP, Acumatica ERP with EWPA QMA and PMS, OptiProERP, Microsoft Dynamics, and more.
- Our professionals have a deep understanding of FDA and FSMA regulatory guidelines.
- We ensure your ERP Software solution is fully aligned with FDA and FSMA cGMP requirements.
- GMP Navigator’s validation services prepare you for FDA and FSMA regulatory inspections with confidence.
- We develop risk-based test scripts along with appropriate monitoring controls.
- GMP Navigator accelerates your validation project by addressing key initial questions such as: “Where do we start?”, “What should be written?”, and “How should it be written?”
- We offer a variety of validation service options tailored to your needs.
- Our team includes experienced, cross-functional validation consultants with a strong record of successful project execution.
Why Our Engagement models are the best amongst all?
- Our solution is scalable and can be used by startups and enterprise-level companies.
- Flexible solutions to match your budget, timeline, and needs.
- Offers a full range of software validation services for Life Sciences businesses, including FDA-regulated enterprises like Pharmaceuticals, Biotechnology, Medical Device, and Nutraceuticals.
- Keeps you inspection-ready always.
- The GMP Navigator team has years of deep industry experience and are updated with all current and upcoming compliance rules.
