The Benefits of ERP and Navigator’s Validation Process

Instead of endless cycles of learning and re-learning, achieve seamless compliance with Navigator's FDA Validation Process. We bridge the gap between knowing what to do and actually doing it, guiding you through the process efficiently and cost-effectively.

Don't let quarterly ERP updates throw you off track. Our experts ensure your system and processes stay compliant with evolving regulations, including:

  • cGMP (21 CFR 210 & 211)
  • FDA Part 11
  • EU GMPs
  • ICH Q7, Q8, Q9, Q10

Focus on what you do best, while we handle the validation complexities.

FDA Validation Process for SAP ERP Solutions

Navigating the complexities of 21 CFR Part 11 and other FDA regulations can be a heavy burden for pharmaceutical, biotech, and medical device companies. Traditional validation processes often require costly third-party audits, slowing down progress and straining budgets.

Navigator offers a smarter solution. Our pre-packaged ERP solutions have built-in compliance features and best practices, saving you time and resources on validation exercises. Our solutions create a validation-ready platform, streamlining the process and ensuring you meet all FDA requirements.

Here's how FDA compliance empowers you:

  • Pre-packaged compliance: Forget time-consuming implementation – our solutions embed essential requirements from 21 CFR Part 11 and other regulations.
  • Reduce audit costs: Eliminate the need for extensive third-party audits, saving you significant financial resources.
  • Faster validation: Streamlined processes and pre-tested best practices get you compliant quicker and smoother.
  • Focus on what matters: Devote your energy to innovation and growth, leaving compliance hassles to us.

Write, coordinate, and execute validation protocols including IQ, OQ, and PQ for process and computer validation. Execute validation test functions in support of approved protocols. Review, summarize, and present data in a summary report for management review and approval.

Don't let FDA compliance hinder your progress. Learn more about Navigator's Validation Process here.

Read "How do I validate our ERP system?"

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