GAMP® Data Integrity by Design (Part 2) | With the large volume of data being generated there need to be metrics and business rules to detect potential issues to control the integrity of the data. With continued outsourcing there is also a significant need to manage the integrity of the vendor's data that could affect the parent company's products. Regulatory agencies are now starting to indicate the need to manage all electronic records over the entire retention period to assure that integrity was maintained back to the original raw data records.
(Presentation 1) Clearly defined business rules and metrics derived from these rules will form an important foundation to efficiently detect potential data integrity problems during review for early intervention before they impact quality and safety.
(Presentation 2) The FDA will provide a perspective on data integrity.
Informatics Specialist-Data Integrity,
Eli Lilly and Company
Biotechnology Specialist Investigator,
U.S. Food and Drug Administration (FDA)