Validation Toolkit

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.

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Services

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

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.