Software Services

        Software validation: CSV, or Computer System Validation, is mandated by regulations such as 21 CFR Part 11, Annex 11, ICH E6 (R2), among others.

        It is relevant to crucial GxP processes and offers oversight and understanding of the computerized systems utilized in these GxP processes.

        KissCSV boasts extensive experience across a multitude of projects in diverse GxP settings.

        If necessary, our validation methodology can be customized to accommodate emerging technologies like machine learning and artificial intelligence.

We are eager to assist you in:

· Comprehending the processes where your computerized system is deployed

· Understanding the workings of your computerized system (white-box approach)

· Determining the lifecycle and software validation strategy

 

Guaranteeing highly uniform data and adherence to all pertinent regulations.

The initial stride towards data integrity!