A Risk Based Approach To IT Infrastructure Qualification & Compliance

Principles & Best Practices for Qualifying Cloud Infrastructure

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.

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