About Validation

Regulatory agencies require that you validate the data you submit as part of your drug approval application. The Oracle Life Sciences Data Hub (Oracle LSH) includes tools to help you to do this, including validation statuses, validation supporting information, and coversheets that include validation information for every report you create.

Oracle LSH cannot certify the quality of the data that you load into Oracle LSH. It is your responsibility to validate data in your source data system(s). However, Oracle LSH can help you certify that Oracle LSH handled data in a valid manner. If you can demonstrate that your source data is valid, and that Oracle LSH manipulated your source data in a valid manner, then data reported or sent out of Oracle LSH must be valid. Each time you generate a report on Oracle LSH data, you can generate a report coversheet that includes the validation status of every defined object that affected the source data for the report, including Tables, Programs, and Load Sets, since the data entered Oracle LSH.

In addition, Oracle LSH allows you to manually validate Program outputs using the same methods you do now. In the context of a Report Set, where different sections may be at different stages of validation at any one time, the system reuses existing, validated outputs as long as any requested outputs would be duplicates of the validated one. Therefore you can continue to develop some sections of a Report Set, changing Parameter values and using new Program versions, and reuse the outputs of other sections as long as your changes do not affect those sections.

Oracle LSH keeps all defined objects under version control. Each version of each object has a validation status. Oracle LSH ships with predefined validation statuses that represent different stages in an object's life cycle: Development, Quality Control, Production, and Retired.

By default, all new objects and all new versions of objects have a validation status of Development. Oracle LSH does not enforce any conditions for promotion of an object to Quality Control or Production. You should develop the standards you require for promotion. Oracle LSH does enforce rules based on objects' validation status and on the interaction of a Work Area's validation status and its Usage Intent attribute value (see Work Area Usage Intent and Validation Status). These rules promote using validation status to create separate, clean, Quality Control and Production environments.

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 with a Program or Report Set, or an output such as a log file or generated report to demonstrate that the Program or Report Set was successfully executed. See Validation Supporting Information for further information.

You can begin application development in Oracle LSH before arriving at your standards for definitional object validation, and it is possible to use Oracle LSH without ever using another validation status beyond Development. However, if you plan to submit data to a regulatory agency, you should not go into production until you have developed standards and validated all objects that operate on or store production clinical data.

All objects that are contained directly in a Domain, Application Area, or Work Area have a validation status.