	The term “software validation” can trigger many responses, including confusion and even anxiety. What is the difference between qualification and validation? Which systems need to be validated? When do systems need to be revalidated? How much validation work is enough? This article provides a foundation for thinking critically about system definitions and software validation, including discussions on the differences between qualification and validation, risk-based validation, and revalidation.

Reduce Risk in a Data Integrity World:Approaches to Ensure Compliance 

Articles

Articles in this Issue

Demystifying Software Validation

 How is change control used to keep software validated?
	

: It is normal that any system needs to be changed over time because of changes in business needs and software updates. The objective is to make sure that those changes are described properly, that the impact and risk of that change is well understood, and that there is documentation to support that assessment of the impact and the risk. A determination is then made regarding the degree of testing or revalidation work that would be required to re-establish that the system is still behaving according to its intended use in the process where it’s going to be used.

Software Validation: Answers to Frequently Asked Questions

	Data integrity issues are changing the way that we should be undertaking
	computerized system validation (CSV) of our chromatography data systems. Do you understand what is required in the brave new world of CSV?

Welcome to the Brave New World of CSV?

What does risk assessment in the context of the life cycle of a high performance liquid chromatography (HPLC) instrument really mean? This article looks at problems with an operational liquid chromatograph to see if they can be picked up in the performance qualification (PQ) or prevented in the operational qualification (OQ). The relationship between PQ and OQ and the design qualification (DQ) phases of the life cycle are also explored.
	 

Reduce Risk in a Data Integrity World:Approaches to Ensure Compliance

LCGC E-Books-07-01-2017

Demystifying Software Validation

Software Validation: Answers to Frequently Asked Questions

Welcome to the Brave New World of CSV?

Life Cycle Risk Assessment of HPLC Instruments