What is there in Common between DI and the Organizational “Immune System”?

Galit Lisaey, Ga.IT Data Integrity Consulting, Givat Ada, Israel (galit.dint@gmail.com)

The importance of maintaining the quality and reliability of the data (Data Integrity) submitted to the authorities, especially in the field of pharmaceuticals, has become a binding requirement. The past thirty years have witnessed a global transition to computerized, automated systems and software. To ensure that critical electronic data presented to the authorities as a basis for decision-making are accurate and reliable, some methodical official guideline documents have been written by the health authorities.

A guideline document on behalf of the US Health Authority called FDA 21CFRPart11 was published in the early 1990s was followed by other documents such as EU Annex 11 for the European authorities, as well as similar documents for the Canadian, Australian and International Health Authority among others.

Between the years 2013 up to 2021 the guidelines have been updated and started to focus more on Data Integrity than ever before.

Data Integrity (DI) training became a mandatory requirement for any organization committed to this subject. The rationale of the proposed lecture is to suggest ways to implement DI principles fundamentally within the organization.

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Short Biography of Presenting Author

Galit Lisaey is a Data Integrity Consultant who helps organizations implement reliable, tailor-made, and accurate tools to meet Data Integrity standards.

With 20 years of experience as Information Technology Project Manager and CSV Expert.

Galit Lisaey established Gal.IT Data Integrity Consulting, out of the realization that many organizations lack the understanding of the need for Data Integrity support unit. The goal is to help them implement this activity through an in-house processes.

The contents of her lectures and courses over the years contribute greatly to helping organizations to meet this requirement.