Overview

Welcome to the Data Integrity Working Group

Failures in data governance and data integrity have plagued the industry for over 15 years. The US FDA, European inspectorate, and WHO have enforced such actions in the US and Europe including countries such as India, China, and Japan. The industry does not appear to have fully met the data integrity requirements and expectations. The Rx-360 Data Integrity Working Group will develop processes, tools, and training to incorporate data integrity best practices.

If you are interested in joining this Working Group please contact us at info@rx-360.org

Publications

Selection and GMP Auditing of Software and Hardware Vendors

December 7, 2022

The Data Integrity Working Group of Rx-360 members has generated an addendum to the previously issued GMP Audit Manual, Data Governance and Data Integrity which provided an approach for GMP auditing and self-assessment of pharmaceutical […]

#Audit Operations Group #Audits #Data Integrity #Data Integrity #Data Integrity #Data Integrity Working Group #Data Integrity Working Group
Events

Virtual European Biomanufacturing Summit

October 4, 2021
#Industry Event #Manufacturing #Supply Chain Security
Interactive Resources

Data Integrity Library

July 25, 2021

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

MHRA

PIC/S

Health Canada

World Health Organization (WHO)

Regulator Enforcement Actions

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.

FDA

WHO

OTHER

Regulator Presentations & 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

MARA

TGA

OTHER ARTICLES & PRESENTATIONS

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

AGILENT

WATERS

LEGAL

ISPE

IPEC

PDA

APIC

PharmTech

INDIA

R.D. McDowall

Katherine Eban

Colgin Consulting

Unger Consulting Inc.

OTHER