A Risk Based Approach To IT Infrastructure Qualification & Compliance


Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance.

The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance.Effective IT Infrastructure Qualification on the other hand, confers the following benefits:

  • Ensures GxP compliance
  • Reduces duplication of effort
  • Ensures adherence to standards
  • Enhances the flow of information throughout an information system
  • Promotes adaptability and agility necessary for a changeable environment
  • Ensures interoperability among organizational and external entities
  • Maintains effective change management policies and practices
  • Although all business activities depend upon the infrastructure, planning and projects to ensure its effective management are typically undervalued to the detriment of the organization.

Establishment and maintenance of a controlled infrastructure requires that infrastructure needs to be brought into initial compliance with the company’s established standards, through a planned qualification process, based upon domestic and international best practices and standards. The qualification needs to be documented and confirmed by Quality Assurance.

The Seminar:

This Seminar provide a risk based approach to meeting current regulatory expectations for compliant IT Infrastructure platforms, including the need to identify, qualify and control those aspects impacted by GxP quality and data integrity. It provides current best practices for the design, qualification and operation of an IT Infrastructure with emphasis on the qualification requirements of the major components. It addresses compliance with international GxP regulations and can be used both for the establishment of new platforms and extensions or existing platforms whether or not they are currently in support of GxP applications. Finally, this seminar covers a range of IT Infrastructures, from those found in companies operating in a global setting to isolated or semi-isolated GxP Infrastructures.

How does IT Infrastructure Qualification fit into GaMP5 lifecycle
Quality Management for Infrastructure
Risk management for Infrastructure Qualification
Installation & Operational Qualification of Infrastructure Componenets
Configuration management and change control of infrastructure components and settings in a highly dynamic environment
Involvement of service provider in critical infrastructure processes
Security management in relation to access controls, availability of services and data integrity
Backup, restore and disaster recovery of IT Infrastructure


Day 1 Schedule

Lecture 1: Introduction and Background
Lecture 2: Quality Management, Quality Manual, Roles Management, Records Management, Documentation Management, Testing Management
Lecture 3: Risk Management, Assessment of Risk Components
Lecture 4: Qualification of Platforms, IT Infrastructure LifeCycle, Planning, Specification & Design

Day 2 Schedule

Lecture 5: Qualification of Platforms (cont’d), Procurement, Reporting, Handover, Exercise
Lecture 6: Operations, Security Management, Upgrade & Patch Management, Server Management, Performance Monitoring
Lecture 7: Operations (cont’d) – Client Management, Network Management, Problem Management,¬†Outsourcing & Supplier Management
Lecture 8: Maintaining the Qualified State


7901 34th Avenue South, Bloomington, MN 55425, USA

$1,295.00 – $7,122.00