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  • Clinical Database Validation

    Disambiguation: Clinical database validation is making sure that clinical databases perform the functions required for 21 CFR 11 and other regulations. Clinical data validation, i.e. checking clinical data for problems, is on another page.

    What is Clinical Database Validation?

    Validation of a clinical database is a structured, documented process to show that the database follows regulatory requirements and performs other functions it needs to perform. This is sometimes summarized as making sure clinical databases are fit for their intended use. In general, database validation is a type of software validation.

    Why do Clinical Databases have to be Validated?

    There are a number of regulations and guidances requiring validation of electronic health records systems, which include clinical databases – see below for a list of the more important ones. The underlying reason for the regulations is that clinical databases affect clinical data, which affect treatment decisions, which affect patient health. Since the patient population in question is virtually all of the United States and a significant fraction of the rest of the world, making sure that clinical databases are fit for their intended use is very important.

    What is the Validation Process?

    Validation is a complex process with many possible variations and options, so specifics vary from database to database, but the general outline is:

    More information on software validation documents and projects is available here.

    Regulations and Guidances

    Other References