Object Validation Standards

Oracle LSH keeps all definitional objects—including Tables, Programs, Report Sets, Workflows, and Data Marts—under version control, and tracks which objects touched which data within Oracle LSH. All Oracle LSH definitional objects have a validation status that represents a stage in the object's life cycle: Development, Quality Control, Production, or Retired. You should develop validation requirements for objects at the Quality Control and Production stages.

Oracle LSH allows you to link documents and outputs with objects to demonstrate that they meet a validation requirement. For example, you can store documents such as Functional Requirements, Test Requirements, or Test Cases for a Program or Report Set, and an output such as a log file or generated report to demonstrate that the Program or Report Set was successfully executed.

Program outputs (reports) also have a validation status. You can specify whether you want a Program's outputs to inherit their validation status or to require manual validation. In the context of a Report Set, you can validate one output manually and continue to reuse that output in the Report Set even though you rerun the Report Set to generate other outputs. For more information, see the chapters on common development tasks and Report Sets in the Oracle Life Sciences Data Hub Application Developer's Guide.

Oracle LSH enforces certain system behaviors based on validation status.

You can begin application development in Oracle LSH before arriving at your standards for definitional object validation, but you should not go into production until you have accomplished this task and validated all objects that affect production clinical data.

Validation concepts and design issues are covered in Validating Objects and Outputs.