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.
- 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.