Businesses that work in GxP-regulated industries need to validate their GxP computerized applications for carrying on their day-to-day operations. A reliable, qualified infrastructure provides control and regulatory compliance of these applications. A noncompliant IT Infrastructure leads to failure of an entire site, and can bring an entire geographic area to a halt till the compliance issue is resolved. Inviting regulatory citations is another consequence of having a noncompliant IT infrastructure.
What happens in such a scenario? A regulated company can have its products recalled, and it can invite warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. Data integrity can also lead to potential patient harm.
Now, what are the benefits of having a compliant IT infrastructure in place? It leads to the following:
- GxP compliance
- Increased adaptability and agility necessary for a changeable environment
- Guaranteed interoperability among organizational and external entities
- Establishment of effective change management policies and practices
- Adherence to standards
- Elimination of duplication of effort
- Enhanced flow of information throughout an information system.
A risk-based approach
A risk based approach to meeting current regulatory expectations for developing compliant IT infrastructure platforms, including the need to identify, qualify and control those aspects impacted by GxP quality and data integrity, will help meet the requirements of qualifying IT infrastructure in a compliant manner.
The knowledge needed for doing this will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. At this seminar, Angela Bazigos, whose is CEO of Touchstone Technologies Silicon Valley, will be the Director.
All about IT infrastructure qualification
The aim of this teaching is to provide current best practices for the design, qualification and operation of an IT infrastructure with a strong emphasis on the qualification requirements of the major components. Angela will explain how to show compliance with international GxP regulations. This compliance 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.
Angela will also take up for discussion a range of IT infrastructures, from those found in companies operating in a global setting to isolated or semi-isolated GxP infrastructures. She will emphasize on the horizontal approach to IT Infrastructure Qualification which brings many benefits, such as a higher level of standardization throughout the entire lifecycle, and highly reduced overlaps in the documentation, qualification and in audits inspections and assessments.
The important aspect of learning over the two days of this seminar are the different platform components and how to adapt a generic qualification strategy for each of these. The Director will cover a range of IT Infrastructures, both cloud and non-cloud, from those found in companies operating globally to isolated or semi-isolated GxP regulated infrastructures.
Angela will cover the following areas at this seminar:
- How does IT Infrastructure Qualification fit into GaMP5 lifecycle?
- Quality Management for Infrastructure
- Risk management for Infrastructure Qualification
- Installation & Operational Qualification of Infrastructure Components
- 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.
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