Quality Assurance as a Service (QaaS)

Our Quality Assurance is offered as a Service to help clients optimize their processes and meet their regulatory and compliance needs.

Quality Assurance as a Service (QaaS)

Our Quality Assurance is offered as a Service to help clients optimize their processes and meet their regulatory and compliance needs.

A leaner set of processes are easy to understand, adopt and execute. Ultragenic QMS can be adopted by Small and Medium sized organizations with minimal need for modifications. It helps simplify your overall compliance framework for GxP systems.

Our QaaS includes:

Standard QMS (set of Processes & Policies)

  • Quality system development, assessment and optimization
  • Corporate quality management systems
  • Review of policy, SOPs and optimization
  • Corrective And Preventive Action (CAPA)
  • Trainings - FDA, QSR and Data Integrity

Quality Management Operational Services

  • Standardization of deliverables such as Validation Plan and Validation Summary Report
  • Quality review of deliverables under QMS and regulations such as FDA, MHRA, PMDA, EMEA

Pre-qualified standard Automation Framework

  • Pre-qualified UFT test framework that can help automate almost any tool or system with minimal updates and no requirement of end to end qualification, leading to almost 90% reduction in framework qualification effort

Standard Validation Kits and automation scripts

  • Standard validation kits for Argus 7.x to current
  • Standard qualification framework for tools like HPQC, JIRA and UFT that can be leveraged readily
  • Automation test scripts development and execution
  • Automation test scripts for regression tests

Audit Framework and Support

  • Establishment of the audit framework and monitoring
  • Onsite vendor audit support
  • Regulatory agencies audit support
  • Audit response

CAPA support services

  • Design and establishment of CAPA framework
  • Preparing responses to agency findings and CAPA