Data Integrity: an effective systems

approachClaire McCluskie

Marketing Executive Life Sciences Ideagen Gael

A Global Issue

One of the top global issues reported in the life science media over the past 2 years

High profile cases:

‘Hot Topic’

A single integrity issue can call into question all of the data produced by a company.

In 2014, 13 of 18 GMP warning letters focused on data integrity violations.

Our ResearchMany data integrity issues arise from:

• Tacit internal pressure to achieve positive outcomes for powerful customers

• The temptation to select results to prove a hypothesis

• Professional ignorance and lack of awareness of SOPs and compliance related requirements

• Shortcuts through an overly bureaucratic process

• Confusion in a fragmented system

Data integrity deficiencies & violations The majority of issues frequently relate to:

• Bad practice

• Fragmented business processes

• Poor organisational behaviour

• Weak Quality Management Systems

Our Message

Data integrity failures DO NOT only result from acts of deliberate fraud

Basic behavioural, procedural and technical steps can improve systems and reduce the risk to data integrity.

A carrot and stick approach by regulators

Sticks = import alerts, interdicts & injunctions and criminal prosecution

Carrots = reduced frequency of subsequent inspections, regulatory flexibility and trust in information from overseas regulatory partners

A positive response

Diligent firms have made improvements to:Inspection regimesManagement structuresQuality management systems

They are aware of shortcomings in business processes rather than dishonest behaviour by individuals.

The data integrity challenge

Modernising obsolete, fragmented and poorly controlled practices and systems

The right solution can eliminate negative operational & cultural practices and drive a culture of openness & integrity.

Turning it around…Turn negative practices and processes into positive ones

• Modernising your operational processes

• Strengthening internal controls

• Eliminating obsolete systems based on paper files, spreadsheets and email

• Addressing professional ignorance and managing competence in research staff

• Modelling and managing risk

One of the largest functional biometrics suppliers in Europe

“Although not able to guarantee data integrity directly, Q-Pulse ensures that the processes required to manage and handle that data are efficient and being followed to the letter. This, in turn, guarantees the integrity of the data we work with as well as the information we produce for clients’ studies”

Lesley Anastasiou, Quality Assurance Manager

Paint the picture

The context of good governance and the management of risk and compliance

A system-level response to a system-based problem

To summarise

Right system = the right behaviours, improve compliance, provide greater assurance of product quality and maintain data integrity