What are the key regulatory requirements for software validation?
An example of an AI chatbot conversation about regulatory requirements in software validation.
What are the key regulatory requirements for software validation?
The key regulatory requirements for software validation include compliance with standards like ISO 9001, FDA regulations, and GxP guidelines.
Can you explain what GxP guidelines are?
GxP stands for Good Practice guidelines, which ensure that products are consistently produced and controlled according to quality standards.
How do these regulations impact software development?
These regulations impact software development by requiring thorough documentation, testing, and validation processes to ensure compliance and quality.
What are the consequences of not following these regulations?
Not following these regulations can lead to product recalls, legal penalties, and damage to a company's reputation.
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