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FDA Validation for Dynamics 365

Our FDA Validation toolkit for Microsoft Dynamics 365 and Dynamics AX is a comprehensive solution for the development of mandatory software validation deliverables.

Armanino Marketplace > FDA Validation for Dynamics 365

Validating software within the highly regulated life sciences systems environment is a daunting task. Armanino understands the unique challenges facing life sciences companies and offers an easy-to-use toolkit with unprecedented services. FDA Validation for Dynamics 365 (and Dynamics AX) is an advanced solution with starter templates, protocols and scripts that let pharmaceutical manufacturers or other life sciences companies quickly and cost-effectively navigate the complicated validation process.

 

Solution Benefits: Solution Features:
  • IQ, OQ and PQ test scripts to accelerate the validation process
  • A comprehensive set of starter templates to fast-track initiatives
  • Quick capture of standard information from common validation practices
  • Flexible test script execution services done by your team or Armanino
  • Low total cost of ownership (TCO) to enable a quick payback 
  • Support for latest GAMP 5 methodology
  • Options for cloud, hybrid or on-premise environments
  • How-to guide for managing validation activities
  • Consulting services assist in the validation process
  • Support for medical devices

 

FDA Validation for Dynamics 365 Simplified

Life science companies that manufacture medical devices, pharmaceuticals or other regulated substances must show that they meet the consistent manufacturing, safety and tracking standards required by law. The FDA and other regulatory agencies validate a manufacturer’s implementation, but also require validation of the intended use of a vendor’s software. Rather than simply validating the software itself, each company is obligated to conduct a complete validation process based on risk.

The software, documentation and services provided in Armanino’s FDA Validation for Dynamics 365 (and Dynamics AX) solution can help reduce the time and expense this requires, by capturing as much of the standard information as possible from common validation practices and templates. The solution provides an excellent starting point to help you decrease the overall effort required for validation and ensure your project is on time and within budget.

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Resources

Life Sciences Solution for Microsoft Dynamics 365 - Operations

Armanino’s Life Sciences Industries for Microsoft Dynamics 365 for Operations

Download our simple, straightforward infographic to see how Armanino’s Life Sciences Industries for Microsoft Dynamics 365 helps companies like yours address FDA compliance, limited distribution, R&D, and so much more. 

Download Infographic »

Life Sciences Benchmarking Survey Cover

Armanino's Life Sciences Benchmarking Survey

Created in collaboration with the Cambridge Healthtech Institute, this concise report shares feedback from more than 100 life sciences business leaders. 

Download Survey »

Armanino's Life Sciences IT Playbook Cover

Life Sciences Manufacturer's IT Playbook

A guide to ERP system infrastructure to support regulatory compliance, FDA validation and supply chain excellence — for fledgling startups to global enterprises.

Download »

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