Thu May 24, 9:00 AM - Fri May 25, 6:00 PM

Embassy Suites Minneapolis - Airport

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

Community: Clinton

Description

These regulatory actions can have significant financial impact to the company. However, and most importantly, data integrity issues can lead to potential patient harm!!

Event Details

Overview:
GxP 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.
The impact of such compliance issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company. However, and most importantly, data integrity issues can lead to potential patient harm!!
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. According to IDC, a prominent research firm (cited in an article in DM Review), investments in infrastructure management have the largest single impact on an organization's revenue.
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 b
A Risk Based Approach To IT Infrastructure Seminar 2018

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