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.


Rx-360:

 

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:

MHRA:

PIC/S:

Health Canada:

World Health Organization (WHO):


REGULATOR ENFORCEMENT ACTIONS:  

Below are Regulator Enforcement Actions that were considered during the development of the Rx-360 Data Integrity Audit Manual.

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.

Below are Regulator Presentations and Blogs that were considered during the development of the Rx-360 Data Integrity Audit Manual.

FDA

HPRA

MHRA

TGA


OTHER ARTICLES and PRESENTATIONS

Below are Articles and Presentations that were considered during the development of the Rx-360 Data Integrity Audit Manual.

AGILENT

WATERS

LEGAL

ISPE

PDA

APIC

PharmTech

INDIA

R.D. McDowall

Katherine Eban

Colgin Consulting

Unger Consulting Inc.

OTHER