Automated Validation Services For Life Sciences Companies

Streamline your validation efforts by using automated testing software to capture, run, and maintain validation test scripts over the life of the system. AKA Enterprise Solutions delivers comprehensive validation services for Microsoft Dynamics AX. Our toolkit follows GAMP 5 and FDA best practices. AKA has two validation service offerings:

 AKA provides a full service validation service offering to our life sciences customers. Through this service offering, AKA provides the services you need to fully validate enterprise technologies in compliance with global regulations and GAMP 5 methodologies. Our services are tailored to meet the needs of each client. Our offering includes the following key deliverables:

  • Validation Workshop
  • Validation Master Plan
  • Validation Project Plan
  • Validation Risk Assessment
  • 21 CFR Part 11 Risk Assessment
  • User Requirements Specification
  • Document Master List (Validation Index)
  • Validation Test Plan
  • Migration Plan
  • Disaster Recovery Plan
  • Installation Qualification (IQ) Test Scripts
  • Operational Qualification (OQ) Test Scripts
  • Performance Qualification (PQ) Test Scripts
  • Trace Matrix
  • Custom ValidationMaster Portal™ (based on Microsoft SharePoint)
  • SOP Development Assistance (optional)
  • Validation Test Script Execution (IQ/OQ/PQ)
  • Automated Validation Testing (Optional)
  • Validation Summary Document
  • Other documents as required by the client

Our validation service has been leveraged by clients who do not have the requisite resources to complete the validation of enterprise systems.   Each engagement begins with a validation workshop. The goal of this custom workshop is to provide an overview of the validation process for each client and provide hands on planning for all validation activities.

 Our validation services includes a portal that provides a SharePoint-based Content Management repository for validation deliverables completed for the project for those clients who are not already using an ECM system.  The portal includes a file hierarchy based on best practices to house validation documentation. If the FDA Validation Toolkit is purchased, validation templates are included.

AKA delivers turnkey validation services using an experienced validation team and project manager to ensure success and help guide our clients through the complexities of enterprise software applications including:

  • Enterprise Technology Validation Planning
  • Disaster Recovery
  • 21 CFR Part 11 Compliance (including electronic records strategies)
  • Validation Test Script Development
  • Validation Risk Assessment
  • Maintaining The Validated State
  • Validation Portal Development
  • Validation Migration Strategies
  • Installation Qualification Strategies
  • FDA Audit Preparation
  • GAMP 5 Principles and Best Practices
  • Automated Validation Testing

Our validation consultants come from the ranks of leading life sciences companies and have the ability to help streamline your validation projects to a one-time successful conclusion.