Thursday, September 26, 2024

Validation

 The primary goal of validation is to ensure that the data, process or products fulfill user needs and requirements in real-world conditions.

Validation is the process of evaluating whether a product, service, or system meets the needs of its intended users and performs its intended functions.


Process Qualification and validation is about verifying that the process design can consistently produce commercial products. There is ongoing monitoring to ensure the process remains in a controlled state.


Types of Process Validation: There are different types of process validation based on when they are performed relative to production:

-Prospective Validation: Carried out during the development stage, before routine production begins.

-Concurrent Validation: Performed during normal production, requiring a full understanding of the process.

-Retrospective Validation: Analysis of accumulated results from past production batches to assess process consistency.

-Revalidation: Periodic checks to ensure systems are still operating as originally validated.


Data Validation: Data validation is the process of ensuring data accuracy and quality. It can be categorized into three main types:

-Pre-entry Data Validation: Prevents incorrect or incomplete data from being entered into a system.

-Entry Data Validation: Checks performed as data is entered to ensure conformity with defined rules.

-Post-entry Data Validation: Assesses and maintains the quality of data already in the system.


Businesses today face the mixed bag of quality data and misinformation, fresh insight, and outdated knowledge. The primary goal of validation is to ensure that the data, process or products fulfill user needs and requirements in real-world conditions.



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