Quality Systems


Our Services.

We provide a variety of consulting services for healthtech compliance needs.

Software Validation

  • Verification of HIPAA compliance
  • 21 CRF Part 11 validation
  • Test case setup
  • Full process documentation

Quality Management Systems

  • QMS setup
  • Controlled document authoring
  • Gap assessment
  • Audit inspection support

Software Architecture

  • HIPAA compliant design
  • Electronic records storage
  • Electronic signatures
  • System security