Data integrity in pharmaceuticals: a look at industry failings
24 November 2015
Data integrity in pharmaceuticals has been a key issue over the past five years, the Sun Pharma and Wochhardt cases being two high profile examples. A single integrity issue can call into question all the data produced by a company and puts patient safety at risk. Auditors have cited an increasing number of data integrity failures in recent years: in 2015, 15 warning letters were sent out, which jumped to 41 in 2016 and 56 in 2017.
According to the World Health Organisation (WHO) “Data integrity is the degree to which data is complete, consistent, accurate, trustworthy and reliable.” The increasing number of issues in this area has spurred the need for both the FDA and MHRA to draft new guidelines on maintaining data integrity, due to be published in 2020.
What causes these failures?
When you take a closer look at data integrity deficiencies and violations cited by the FDA, MHRA and other European regulatory authorities, the majority of issues frequently relate to inadequate systems and processes. Breaking this down further, data integrity issues also arise from:
- Internal pressure to achieve positive outcomes for powerful customers
- The temptation to select results to prove a hypothesis
- Shortcuts through an overly bureaucratic process
- Confusion in a fragmented system
- Professional ignorance and lack of awareness of SOPs and compliance-related requirements
This dispels the general misconception that data integrity failures only result from acts of deliberate fraud and highlights the factors that need to be addressed to improve things.
WHO have identified that continued reliance on manual processes is one of the root causes of data integrity infringements. This includes the use of digital systems that aren’t validated and robust enough and organisations that are mid-way through updating to a fully digital quality management system.
The obstacle that many organisations face is the lengthy process of setting up and adapting to a new way of operating, which includes having to digitalise all their files and train employees in how to use the system. Making these changes is crucial however to comply with data integrity requirements and maintain and prioritise quality and patient safety.
Moving towards better data integrity standards
As a supplier of quality, compliance and risk management software, we know the importance of data integrity in pharmaceuticals. The data integrity challenge for the vast majority of businesses is not rooting out malpractice, but rather modernising obsolete, fragmented and poorly controlled practices and systems. This includes document management, internal audit, training and competence and third-party management.
The right solution can eliminate negative operational and cultural practices, instead driving a culture of openness and integrity.
This can be done by:
- 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
The challenge of data integrity should be looked at in the context of good governance and the management of risk and compliance. This drives businesses towards a system-level response to a system-based problem.
Our latest white paper 'A nudge in the right direction: Assuring data integrity in the life science industry' discusses the implementation of effective behavioural, procedural and technical steps. These steps, supported by appropriate systems, will encourage the right behaviours, improve compliance, provide greater assurance of product quality and maintain integrity throughout the data lifecycle.
Download the white paper to learn more about the role of data integrity in pharmaceuticals.