Service Areas

QAaaS-MI | Systems Compliance specialists for GLP regulated Pre-Clinical Study Operations.
GLP Audits
QAaaS-MI performs Quality Assurance audits for clients regulated by 21 CFR Part 58 & Part 11. We can serve as supplemental personnel to your organization and perform GLP functions of the Quality Assurance Unit. As Systems Compliance specialists, audits are focused in the following areas:
  • System Use & Computer Validation
  • IT Operations
  • Software Development
  • Equipment Qualification
  • Vendor Assessment
GLP Operations Guidance
Compliance is a pillar within the operations of a Pre-Clinical Laboratory. QAaaS-MI emphasizes the practical application of progressive and innovative ideas that assure regulatory compliance while maintaining operational efficiency. We are prepared to help your organization move forward in a variety of Systems Compliance related areas:

  • Laboratory Operations
    • Training Strategies for system use
    • SOP authoring for system use

  • IT Operations
    • Infrastructure Qualification
    • Software Qualification
    • Outsourcing of personnel
    • Training Strategies for IT personnel
    • Hosted services use
    • Vendor assessment
    • Problem Management and Disposition
    • Risk Management
GLP Supplier Guidance
Win more Requests For Proposal with your GLP regulated clients by understanding your role as a supplier in Systems Compliance. With the needed procedural controls and evidence of completion in place, clients are able to leverage your work and reduce implementation time of your products and services in their Pre-Clinical Studies. QAaaS-MI can show you how to reconfigure and enhance your current business operations to align with GLP conventions and accelerate client implementation.
  • Equipment Qualification
  • Software Development
  • Software Qualification
  • Infrastructure Qualification
  • Hosted Services Management
  • Personnel Qualification & Training