Document

Data Integrity Library

Author:

Data Integrity Working Group

About the Data Integrity Library: This library is a collection of up to date publications associated with the topic of data governance and data integrity.  The collection is divided into four main groups with each of those further subdivided by country or topic.  The intent is to maintain this as a living collection with frequent updates.


REGULATIONS and GUIDANCE Included in this category are health authority regulations, guidance and guidelines associated with data governance and data integrity.  They are divided by country specific health authority.

CHINA:

EMA:

FDA:

HEALTH CANADA:

MHRA:

PIC/S:

World Health Organization (WHO):


REGULATOR ENFORCEMENT ACTIONS:  

FDA

WHO

OTHER


REGULATOR PRESENTATIONS AND BLOGS: This section provides slide decks, blogs and other articles written and presented by health authorities on the topic of data governance and data integrity.  These are divided by country and specific authors and years of presentation / publication are identified.

FDA

HPRA

MHRA

TGA


OTHER ARTICLES and PRESENTATIONS

AGILENT

OTHER

LEGAL:

ISPE

PDA

PharmTech

INDIA

Unger Consulting Inc.