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FDA Validation


Benefits

Software validation within highly regulated life sciences systems environments can be a daunting task – especially for transaction-oriented systems such as enterprise resource planning (ERP). Armanino understands the unique challenges facing life sciences companies and offers a comprehensive solution to facilitate the development of mandatory software validation deliverables in an easy-to-use toolkit.

The U.S. Food and Drug Administration (FDA) Validation Toolkit for Process Industries for Microsoft Dynamics AX delivers best practices at your fingertips. It offers unprecedented services, coupled with validation starter templates, protocols and scripts, to let pharmaceutical manufacturers or other life sciences companies quickly and cost-effectively navigate the complicated validation process.

Key Enhancements offered by the FDA Toolkit include:

  • Support for Latest Good Automated Manufacturing Practice (GAMP) 5 methodology
  • Updated Validation Master Plan (VMP) including risk assessment
  • Support for a hosted or virtual systems environment, or installation directly on your servers
  • Support for medical devices (discrete processes)
  • Includes test protocols for 20 new business processes
  • Virtualization scripts
  • Estimated $50K+ in consulting cost savings
  • Enhanced “Introduction to FDA Validation” video delivered on DVD Includes validation verification videos that show recorded session running test scripts
  • Toolkit delivered in convenient DVD format

Complete Validation Processes Quickly

Companies that manufacture medical devices, pharmaceuticals or other regulated substances must demonstrate that they can meet the consistent manufacturing, safety and tracking standards required by law. Armanino Consulting’s FDA Validation Toolkit includes:

  • a “how to guide” for project management, risk assessment, tracking and managing validation activities
  • templates for completing the documentation required by the U.S. FDA
  • documentation for a vendor audit of Process Industries for Microsoft Dynamics AX
  • consulting services to assist the manufacturer in completing the validation process 

Capture Standard Information to Reduce Time and Effort

The U.S. FDA and other similar regulatory agencies worldwide validate a manufacturer’s implementation and intended use of a vendor’s software rather than the software itself, forcing each life sciences company to conduct a complete validation process based on risk. The software, documentation and services provided in Armanino Consulting’s FDA Validation Toolkit can help reduce the time and effort required by capturing as much of the standard information as possible from common validation practices and templates. 

Experience Low Total Cost of Ownership (TCO) and Achieve a Quick Payback

Because Microsoft Dynamics AX for High Tech Industries is built on proven Microsoft products and technologies, your business can take advantage of existing IT investments such as Microsoft Office System applications and the Microsoft Windows Server System™. Lower total cost of ownership can help your company realize a faster payback on your investment.

Features Overview

Feature

Capabilities

 

Validation Document Templates

The validation toolkit includes a comprehensive set of starter templates to accelerate validation initiatives. These templates are pre-populated and formatted for ease of use and editing. The starter templates include:

  • Validation Master Plan (with risk assessment)
  • User Requirement
  • Software Plan
  • Requirements Disaster Recovery
  • Software Traceability
  • Validation Test Plan
  • Supplier Audit Checklist
  • Internal Procedures
  • Signature Matrix
  • Validation Standard Operating Procedures
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Summary Report

plus many others…

Validation Test Scripts

Armanino Consulting offers IQ, OQ, and PQ test scripts to help accelerate the validation process. These scripts provide an excellent starting point to help reduce the overall time and effort required for validation.

Validation Project Management

Our validation consultants come from the ranks of leading global life sciences companies. Their experience and proven validation methodologies deliver valuable assistance to ensure your project is on time and within budget.

Test Script Execution Services

Our flexible test script execution services are designed to be delivered either with assistance from members of your team or we can execute the scripts for you, saving you time and money.