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The "let me rest while computers do the rest" misconception is not only a grave mistake in the life sciences that could jeopardize your company's reputation and entire operations, it also undermines the need for the much-needed human oversight to ensure your data's level of accuracy, compliance, and ethical responsibility.
As we have always reiterated, life sciences businesses should always view data integrity as a responsibility to be fulfilled and not just another regulatory checkbox that must be ticked to meet operational requirements. Looking at data integrity as a burden or treating it as an afterthought will not only put you and your patients at risk, it will also blind you to the common and easily avoidable gaps we often find in our data integrity assessments for clients such as lack of audit trails and the use of non-validated systems.
PQE’s Data Integrity Quick Assessment & The Importance Of Data Integrity In Pharma
Regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have set clear expectations for data integrity, which include checks on data consistency and accuracy throughout the lifecycle of the data.
Data integrity is an important element of data lifecycle management, and plays a key role in this process as it ensures that the data we are collecting during our operations is obtained, properly recorded, processed, stored, and retrieved in a safe and secure way that aligns with ALCOA+ principles which require data to be Attributable, Legible, Contemporaneous, Original, and Accurate.
These standards are not only reserved for digital data; they apply to paper-based systems as well, which must guarantee traceability, completeness, and protection against unauthorized access, loss, or alteration throughout the data’s retention period. Data integrity violations have historically been tied to gaps which compromise the reliability and trustworthiness of data, such as poor record-keeping practices and insufficient controls which led to regulatory action, damaging both company reputation, finances and patient safety.
PQE Group has long recognized the risks attached to non-compliance stemming from process gaps, inadequate controls, and the lack of proper data integrity management and has developed a Data Integrity Quick Assessment Tool for life sciences companies to reflect on their current practices and see which areas need to be addressed to achieve full regulatory compliance.
The 3-level assessment, which is scored from low to high, is designed to assess your data integrity level based on key metrics such as employee training and compliance with regulatory standards. A low score on this assessment indicates the prevalence of severe gaps in data integrity due to issues such as the reliance and use of manual or outdated systems as well as an unsatisfactory level of employee training.
Businesses that obtain this low score have much room for improvement in terms of modernization and employee training and must take immediate corrective actions, by either investing in digital solutions, or implementing structured training programs to bring their data practices in line with industry and regulatory expectations. If your business scores high, however, it is a sign that your company is on the right track and needs to continue ensuring alignment with data integrity best practices. While this is the desired score, it does not mean that you should remain complacent, as continuous monitoring, periodic assessments, and investments in new and emerging technologies such as AI and Machine Learning are necessary to maintain strong data governance and stay ahead of evolving regulatory landscapes.
Common Challenges Life Sciences Companies Face In Implementing Data Integrity Best Practices?
Life science organizations are still facing a variety of challenges when trying to implement effective data integrity practices within their Quality Management Systems. These hurdles, which range anywhere from inadequate employee training to a global lack of data quality culture, are affecting dozens of companies and can potentially cost them significant amounts of money as a result of regulatory actions (e.g. product recalls, suspension of manufacturing authorizations, reputational damage or fines). Coupled with insufficient controls and outdated systems, these common and avoidable challenges continue to pose a threat to the life science businesses’ operations.
Oversight has also been an issue in recent years as strong outsourcing trend within pharmaceutical industry is clearly visible.. Contrary to popular belief, third parties providing outsourcing activities are subject to the same data integrity and ALCOA+ principles, which often causes confusion and adds to the complexity of an issue that is already difficult to manage for most of these companies. The complexity of processes and the large volumes of data being generated by modern life sciences companies require strategic and tactical approaches to data management, employee training, and overall operational efficiency starting with the development of a 'quality culture' where every employee is responsible for quality and not just a select few.
PQE Group’s Data Integrity Assessment is the first step your company should take to ensure your organization adheres to regulations and data integrity principles while building a strong internal culture of accountability that promotes transparency, continuous monitoring, and improvements.
Gain instant insights into your Data Integrity performance - It starts with one quick check.
