significant benefits for their consumers. At
the same time, the impact of this transformation resulted in a 20- to 40-percent cost
reduction and improved throughput time. 2
Many of these industries also have to comply with regulations, and with safety and
security standards. Instead of learning from
other industries, adopting best practices
and optimizing them, we (suppliers, regulators, industry, etcetera) are all struggling
to make a fundamental mindset shift to
eliminate the vital barriers to create a huge
adoption of new technologies.
• When did you last wait in line to check
in for a flight at an airport?
• How often have you been able to reserve
your favorite seat in advance?
• Have you mailed a check to initiate a
financial transaction lately?
• Have you adjusted the way you communicate with your peers and colleagues
during the last 10 years?
The bottom line is that we constantly
adjust our own processes and mindsets to
maximize our personal way of working.
So, how much has been changed in the
way we capture experimental data from
instruments in our daily laboratory work?
Review and Critique of the MRHA Data
Integrity Guidance for Industry
This new series of four articles takes a look at he UK’s Medicines and Heathcare products Regulatory Agency (MHRA) guidance for industry on data integrity. The focus of these articles is an
interpretation and critique of the second version of the
MRHA data integrity guidance for laboratories working
to European Union GMP regulations, such as analytical
development in R&D and quality control in pharmaceutical manufacturing. In doing so, some of the main
differences between the first and second versions of the
document will be highlighted and discussed.
Part 1: Overview
Topics in this introductory article include the global data integrity problem,
drowning in integrity definitions and an overview of the MHRA data integrity
guidance overview — setting the scene, and a discussion of the wrong definition
of data and integrity criteria. There is a discussion of “1 in 28” member states
of the European Union; why is the UK not co-ordinating with the rest of the
• Read Part 1: http://bit.ly/1eDIehP
Part 2: Data Governance System
In the second part, we look at the MHRA requirement for a data governance
system — is there a basis for this when interpreting EU GMP Chapter 1? The main
elements for a data governance system are presented and discussed — we also compare with an extreme example of a data governance system set up by a company
following a consent decree with the FDA.
• Read Part 2: http://bit.ly/1eDIj4X
Part 3: Data Criticality and Data Life Cycle
This section of the guidance first looks at data generation: data integrity risk
and criticality via different ways of generating data from observation to an electronic computerized system using electronic signatures. In addition, we consider
the components of a laboratory data lifecycle and look at some of the issues
• Read Part 3: http://bit.ly/1FeFLzR
Part 4: System Design, Definitions and Overall Assessment
In this final part of the series, we look at the section on system design and
discuss the key definitions that constitute the bulk of the guidance document. The
series finishes with an overall assessment of the guidance document: the good
parts and the poor parts.
• Read Part 4: http://bit.ly/1RvwETY
R.D. McDowall is Director, R D McDowall Limited. He may be reached at
R.D. McDowall, Ph.D.