Summary

This article provides a list of validation statements and 21 CFR Part 11, if applicable.

Table of Contents

• Additional Products
• DATATRAK Business Platform
  • Datatrak Enterprise Cloud 14.7.1 – March 02, 2022
  • Datatrak Enterprise Cloud 14.7.0 – December 12, 2021
  • Datatrak Enterprise Cloud 14.6.3 – April 14, 2021
  • Datatrak Enterprise Cloud 14.6.2 – February 28, 2021
  • Datatrak Enterprise Cloud 14.6.1 – January 20, 2021
  • Datatrak Enterprise Cloud 14.6.0 – November 22, 2020
  • Datatrak Enterprise Cloud 14.5.5 – July 29, 2020
  • Datatrak Enterprise Cloud 14.5.4 – June 24, 2020
  • Datatrak Enterprise Cloud 14.5.3 – May 20, 2020
  • Datatrak Enterprise Cloud 14.5.2 – April 8, 2020
  • Datatrak Enterprise Cloud 14.5.1 – March 3, 2020
  • Datatrak Enterprise Cloud 14.5.0 – February 23, 2020
  • Datatrak Enterprise Cloud 14.4.5 – January 29, 2020
  • Datatrak Enterprise Cloud 14.4.4 – September 29, 2019
  • Datatrak Enterprise Cloud 14.4.3 – August 26, 2019
  • Datatrak Enterprise Cloud 14.4.2 – August 7, 2019
  • Datatrak Enterprise Cloud 14.4.1 – July 28, 2019
  • Datatrak Enterprise Cloud 14.4.0 – June 16, 2019
  • DATATRAK ONE 14.3.4 – March 17, 2019
  • DATATRAK ONE 14.3.3 – February 10, 2019
  • DATATRAK ONE 14.3.2 – October 11, 2018
  • DATATRAK ONE 14.3.1 – September 21, 2018
  • DATATRAK ONE 14.3.0 – September 09, 2018
  • DATATRAK ONE 14.2.2 – March 14, 2018
  • DATATRAK ONE 14.2.1 – March 7, 2018
  • DATATRAK ONE 14.2.0 – February 25, 2018
  • DATATRAK ONE 14.1.2 – August 8, 2017
  • DATATRAK ONE 14.1.1 – July 12, 2017
  • DATATRAK ONE 14.1.0 – June 25, 2017
  • DATATRAK ONE 14.0.3 – February 03, 2017
  • DATATRAK ONE 14.0.0 – November 27, 2016
  • DATATRAK ONE 13.3.7 – May 03, 2016
  • DATATRAK ONE 13.3.0 – May 31, 2015
  • DATATRAK ONE 13.2.0 – December 14, 2014
  • DBP 13.0.0 – June 22, 2013
  • DBP 12.0.0 – June 7, 2012
  • DBP 11.0.0 – December 21, 2011
  • DBP 10.0.0 – October 24th, 2010
  • DBP 9.0.0 – December 5th, 2009
  • DBP 8.0.0 – March 7th, 2009
  • DBP 7.0.0 – September 27, 2008
  • DBP 6.0.0 – April 19, 2008

Both a Software Validation Statement and 21 CFR Part 11 Statement accompany each major release of the software product. Qualification Statements also accompany some products related to the DBP product. Below you will find links to the PDF documents produced as a result of Quality Assurance’s oversight of the Software Development Life Cycle

Additional Products

AWS as DATATRAK’s Disaster Recovery & Business Continuity Site

• Qualification Statement

BlueBridge Networks’ Hybrid Infrastructure As A Service (IAAS) Cloud serves as DATATRAK’s Production Environment

• Validation Statement

DATATRAK Business Platform

Datatrak Enterprise Cloud 14.7.1 – March 02, 2022

• Datatrak Enterprise Cloud 14.7.1 Software Validation Statement

Datatrak Enterprise Cloud 14.7.0 – December 12, 2021

• Datatrak Enterprise Cloud 14.7.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 14.7.0

Datatrak Enterprise Cloud 14.6.3 – April 14, 2021

• Datatrak Enterprise Cloud 14.6.3 Software Validation Statement

Datatrak Enterprise Cloud 14.6.2 – February 28, 2021

• Datatrak Enterprise Cloud 14.6.2 Software Validation Statement

Datatrak Enterprise Cloud 14.6.1 – January 20, 2021

• Datatrak Enterprise Cloud 14.6.1 Software Validation Statement

Datatrak Enterprise Cloud 14.6.0 – November 22, 2020

• Datatrak Enterprise Cloud 14.6.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 14.6.0

Datatrak Enterprise Cloud 14.5.5 – July 29, 2020

• Datatrak Enterprise Cloud 14.5.5 Software Validation Statement

Datatrak Enterprise Cloud 14.5.4 – June 24, 2020

• Datatrak Enterprise Cloud 14.5.4 Software Validation Statement

Datatrak Enterprise Cloud 14.5.3 – May 20, 2020

• Datatrak Enterprise Cloud 14.5.3 Software Validation Statement

Datatrak Enterprise Cloud 14.5.2 – April 8, 2020

• Datatrak Enterprise Cloud 14.5.2 Software Validation Statement

Datatrak Enterprise Cloud 14.5.1 – March 3, 2020

• Datatrak Enterprise Cloud 14.5.1 Software Validation Statement

Datatrak Enterprise Cloud 14.5.0 – February 23, 2020

• Datatrak Enterprise Cloud 14.5.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 14.5.0

Datatrak Enterprise Cloud 14.4.5 – January 29, 2020

• Datatrak Enterprise Cloud 14.4.5 Software Validation Statement

Datatrak Enterprise Cloud 14.4.4 – September 29, 2019

• Datatrak Enterprise Cloud 14.4.4 Software Validation Statement

Datatrak Enterprise Cloud 14.4.3 – August 26, 2019

• Datatrak Enterprise Cloud 14.4.3 Software Validation Statement

Datatrak Enterprise Cloud 14.4.2 – August 7, 2019

• Datatrak Enterprise Cloud 14.4.2 Software Validation Statement

Datatrak Enterprise Cloud 14.4.1 – July 28, 2019

• Datatrak Enterprise Cloud 14.4.1 Software Validation Statement

Datatrak Enterprise Cloud 14.4.0 – June 16, 2019

• Datatrak Enterprise Cloud 14.4.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 14.4.0

DATATRAK ONE 14.3.4 – March 17, 2019

• DATATRAK ONE 14.3.4 Software Validation Statement

DATATRAK ONE 14.3.3 – February 10, 2019

• DATATRAK ONE 14.3.3 Software Validation Statement

DATATRAK ONE 14.3.2 – October 11, 2018

• DATATRAK ONE 14.3.2 Software Validation Statement

DATATRAK ONE 14.3.1 – September 21, 2018

• DATATRAK ONE 14.3.1 Software Validation Statement

DATATRAK ONE 14.3.0 – September 09, 2018

• DATATRAK ONE 14.3.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 14.3.0

DATATRAK ONE 14.2.2 – March 14, 2018

• DATATRAK ONE 14.2.2 Software Validation Statement

DATATRAK ONE 14.2.1 – March 7, 2018

• DATATRAK ONE 14.2.1 Software Validation Statement

DATATRAK ONE 14.2.0 – February 25, 2018

• DATATRAK ONE 14.2.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 14.2.0

DATATRAK ONE 14.1.2 – August 8, 2017

• DATATRAK ONE 14.1.2 Software Validation Statement

DATATRAK ONE 14.1.1 – July 12, 2017

• DATATRAK ONE 14.1.1 Software Validation Statement

DATATRAK ONE 14.1.0 – June 25, 2017

• DATATRAK ONE 14.1.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 14.1.0

DATATRAK ONE 14.0.3 – February 03, 2017

• DATATRAK ONE 14.0.3 Software Validation Statement

DATATRAK ONE 14.0.0 – November 27, 2016

• DATATRAK ONE 14.0.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 14.0.0

DATATRAK ONE 13.3.7 – May 03, 2016

• DATATRAK ONE 13.3.7 Software Validation Statement

DATATRAK ONE 13.3.0 – May 31, 2015

• DATATRAK ONE 13.3.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 13.3.0

DATATRAK ONE 13.2.0 – December 14, 2014

• DATATRAK ONE 13.2.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 13.2.0

DBP 13.0.0 – June 22, 2013

• DATATRAK ONE 13.0.0 Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 13.0.0

DBP 12.0.0 – June 7, 2012

• Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 12.0.0

DBP 11.0.0 – December 21, 2011

• Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 11.0.0

DBP 10.0.0 – October 24th, 2010

• Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 10.0.0

DBP 9.0.0 – December 5th, 2009

• Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 9.0.0

DBP 8.0.0 – March 7th, 2009

• Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 8.0.0

DBP 7.0.0 – September 27, 2008

• Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 7.0.0

DBP 6.0.0 – April 19, 2008

• Software Validation Statement
• 21 CFR Part 11 – DATATRAK Comments for DBP 6.0.0

Need more help?

Please visit the Fountayn Contact Information page.