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# Enter Data First to Database: Lilly Exec
- URL: https://www.fdaweb.com/enter-data-first-to-database-lilly-exec/
- Published: 2016-10-04T12:00:00.000Z
- Updated: 2026-09-14T21:36:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136991

Lilly associate senior consultant for global quality laboratories **Mark Newton** says there is the potential for adverse pharmaceutical data integrity impact when companies uses a layered approach, such as a data entry forms layer, business rules layer, and database layer. Writing in an online blog [post](http://blog.ispe.org/data-entry-pharmaceutical-data-integrity?ref=fdaweb.com), Newton references a recent draft FDA data integrity guidance that says it is not acceptable to store data electronically in temporary memory in a manner that allows for manipulation before creating a permanent record.

In a layered approach, he writes, segregation permits each layer to be modified without forcing major changes in other layers. However, while there are maintenance advantages, the approach carries hidden data integrity risks. Thus, Newton says, designers can use a database trigger to validate a value or perform a calculation for the information just entered by the user.

“The key to reducing the risk,” he says, “is changing the design so entries are first written to the database \[and\] then calculated and validated. This design then permits the creation of an audit trail to capture entry changes, so reviewers can see the complete record and determine if the entry changes are proper.”