GXP Systems

Establishing a Successful Data Integrity Management Culture

  • Tuesday, August 29, 2017

In our previous whitepaper series, Data Integrity in Regulated and Accredited Environments, we discussed the fundamentals and principles of effective Data Integrity Management, including outlining some of the best practices associated with strong DI management.

It is highly recommended that a Data Integrity Management Master Plan (DIMMP) be created to serve as a roadmap to control and direct data integrity activities as this is key to the success of Data Integrity Management. However, for the most carefully designed plan to be implemented correctly and smoothly, it is essential that one key component is properly utilised – the role of personnel. Establishing a culture of Data Integrity and Quality is critical to getting the most from people.

So, what is the best way to go about this, you might ask? Here are three key areas that can successfully educate and encourage people to develop an environment based on data integrity:-

  1. Training & Development on best practices
  2. Reward ethical behaviour/tackle unethical behaviour
  3. Encourage whistle-blowing

Training & Development on best practices

The easiest way to begin to foster a DI culture is at the induction stage, whereby you get the opportunity to outline a new employees’ role and responsibilities, the type of tasks that generate data and how important it is to correctly record and archive all types of relevant data.

For existing staff, it’s no harm to organise refresher training on policies and procedures, ensuring awareness of the importance of their role in ensuring data integrity & the implications of incorrect or misleading data.

Reward ethical behaviour/tackle unethical behaviour

Expectations around ethical behaviour should be communicated frequently and openly. It could also be a good idea if good DI practice was rewarded - perhaps by way of recognition or financial reward for achieving key milestones (successful audit etc).

Unethical and dishonest behaviour must be completely eliminated because corrupted data can have a diverse effect directly on patients, as well as all of the commercial ramifications. Personnel should understand the consequences of acts of unacceptable behaviour, such as the deliberate falsification of data, unauthorised changes, destruction of data etc. Data fabrication or falsification can result in criminal action being taken against the relevant people.

Encourage whistleblowing

Because of the high sanctions that can be introduced if an organization is found guilty of a breach of data integrity, a whistle-blowing policy should be introduced and openly communicated.  It’s understandable that individuals may make mistakes or errors, but covering it up or falsifying data is not acceptable. Staff should feel empowered to communicate any possible compromised data, irrespective of the cause, so that the appropriate action may be taken.

These three areas are only successful if management adequately champion a data integrity culture and buy in to the need for change to the existing structure. But, let’s not forget that management are personnel too!

 

 

Author: Damien Hanley

              Marketing Manager

              Stericycle GxP Solutions

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