Understanding the Impact of Culture and Behaviours on Data Integrity Compliance

Data Integrity refers to the completeness, consistency and accuracy of data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate. The integrity of data is not a new requirement, in fact, data integrity is referenced 65 times in the Good Automated Manufacturing Practice (GAMP) 5 Guidance Document “Compliant GxP Computerized Systems” which was published in 2008.

With the increasing trend of data integrity related warning letters being issued by the FDA, which is graphically represented below, it is important to understand the link between data integrity breaches and cultural behaviour in the workplace.

Data integrity associated warning letters

 (Source:https://www.pharmaceuticalonline.com/doc/an-analysis-of-fda-warning-letters-on-data-integrity-0003)

Culture can be described as a way of life of a group of people or employees – the behaviours, beliefs, values, and symbols that they accept, generally without thinking about them, and that are passed along by communication and imitation from one person to the next. Culture is not something that can be created or changed overnight It is an evolutional process that evolves over time and is created when people at all levels within an organisation live, breathe and practice a shared set of values and assumptions.

Culture determines quality outcomes, because it affects an organisations ability to identify and act upon near misses, assure transparent problem escalation and strive for operational excellence.

The application of psychological and physiological principles to the design of products, processes, and systems can reduce human error and increase productivity but understanding what impacts the human factors is imperative. The International Society for Pharmaceutical Engineering (ISPE) GAMP guide entitled “Records and Data Integrity Guide” provides a very clear overview of the impact of human factors on data integrity. It states that “when pressures are combined with the opportunity for data falsification, presented by poor technical controls, it can be just a small step further for an employee to rationalize that altering the data is a minor misdemeanour and may even save the company money in the longterm.” It continues with the explanation that “at this point the employee now has the motive (pressure) and ability (opportunity) to commit fraud and has even convinced himself or herself that it is in the company’ best interest to do so (rationalisation) when, in reality, fraud can only be detrimental to both the company and the employee.”

The full ISPE GAMP guide can be purchased at the following link: https://ispe.org/publications/guidance-documents/gamp-records-pharmaceutical-data-integrity#

Habits drive behaviour, which in turn drives culture. How to break this cycle is to form habits to change behaviour and thus to change culture. They key here is to be persistent, it has been stated that to change a known habit means to repeat the new habit 60 times.

Many companies have introduced data integrity programmes to help to embed compliance to data integrity into corporate practices and procedures. Here you will find some recommendations on how to construct a successful data integrity programme within your organisation:

• Ensure the scope is established and approved from the outset. This is achieved by drafting a project charter and writing detailed project plans so that all personnel have a common understanding of the scope and their own accountabilities. In parallel,  the team should be appointed and governing procedures should be in place.
• Different types of training should be rolled out – onboarding training for all employees, management training and role-specific training. The emphasis on data integrity should be customised and tailored in-line with the target audience.
• The development of a data integrity assessment tool based on data integrity principles extracted from different regulations and guidance is a useful method for consistently performing data integrity assessments across systems and processes.
• Build data integrity into the internal self-inspection programme and also into individual professional development plans and annual goal setting to help foster a culture that the implementation of data integrity into all tasks on a daily basis becomes the norm.
• Showcase and promote how you are implementing data integrity across the plant through the use of advertising using posters, flyers, newsletters etc.

Once cultural behaviour has been successfully achieved by all employees the results will speak for themselves. Some of the benefits associated with cultural excellence include:

• Adding value for customers
• Creating a sustainable future
• Developing organisational capability
• Harmonising creativity and innovation
• Leading with vision, inspiration and integrity
• Managing with agility
• Succeeding through the talent of people
• Sustaining outstanding results

If you require support in conducting a data integrity assessment or advice on how to develop a data integrity programme within your company please connect with us +353 1 846 4742 or contactirl@pharmalex.com