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Körber emphasizes basic disciplines in ensuring data integrity
Karlsruhe, Germany – Integrated life sciences solutions provider Körber Business Area Pharma has shared insights on making sense of data integrity in its latest blog, emphasizing that this is a human and organizational challenge, rather than just a technological one.
The article State of the Art Data Integrity – A Critical Inventory explains the importance of data integrity and sheds new light on risk assessment and organizational controls as relevant factors in achieving regulatory compliance. The blog also explores the increasing importance of new human roles, identifies emerging trends and elaborates on data governance and life cycle management.
Back to ALCOA+ basics
Data integrity is rooted in the concept that if the original data is flawed, everything built on that data is fatally compromised. In a world where almost all products and services now have some data components, this is the most compelling argument for taking data integrity very seriously.
Data integrity for the life sciences industries is codified by a plethora of standards and regulatory bodies, including FDA, NIST, IEEE, EU and MHRA. However all are based on ALCOA: an acronym for the original five principles of data integrity:
- Attributable: you know where and when the data originated and which person/machine generated them
- Legible: the data are capable of being read (by human or machine)
- Contemporaneous: the data were generated at the time when original activity took place and therefore forms the contemporary record of that activity
- Original: the data haven’t been copied, adulterated or compromised with constant possibility to revert to original recording
- Accurate: the data are error free with no information removed without a full record of changes.
In ALCOA+, the original principles are joined by four more:
- Complete: All recorded data is accompanied by an audit trail to show what has been changed, deleted or lost.
- Consistent: ensuring data is chronological, with date and time stamps to confirm a consistent sequence.
- Enduring: specific emphasis on ensuring data is available long after it is recorded – even decades hence.
- Available: data must not only exist, they must be accessible, normally through electronic recording and storage.
Under GxP standards, the ALCOA+ principles apply to all data records: electronic, paper-based, visual and audio.
Data integrity challenges
Körber points out that data integrity has become a mission critical issue for pharma and healthcare for at least two reasons. The first is that data underpin the whole decision making tree for manufacturing and delivery, including issues that have direct impact on patient safety and product quality.
The second is regulatory compliance. Analysis of FDA FY2019 Drug GMP Warning Letters reveals that on average roughly half the FDA’s warning letters over the last five to seven years have involved data integrity issues, with consequences ranging from reputational damage and expensive product recalls to being excluded from lucrative markets.
Körber Business Area Pharma consultants identify a ‘rogues gallery’ of the most common data integrity problems, such as poor access control and security measures, missing audit trails, lack of contemporaneous recording, unaccounted data discrepancies, loss of original data, and fraud.
They identify the main causes of such problems as temporary storage of data, poor system interfaces, manual transcription or data entry errors, failure to control access, software or configuration errors and hardware failures.
Data integrity rewards
On the upside, companies handling their valuable data with care not only benefit from better decisions and gain more trust, but they sharpen their position for new opportunities, too.
The reward for successful data governance is the flipside of data integrity issues: improvements in quality, a reduced number of defects, fewer recalls, higher confidence, and overall better decision making.
It is also the gateway to the huge opportunities provided by full digitization and Big Data as humans and systems combine to create, update, share, store, analyze, and transform data into competitive advantage. As Merck CEO Stefan Oschmann, recently remarked: “Big data is essential … it will be just as important as biology or chemistry.”
As for the ongoing ‘trend’ towards artificial intelligence (AI) that has become such a hot topic for the pharmaceutical industry, data integrity is the driving factor that cannot be understated with automated decision making within grasp, given the right tools and data.
Crucial: the human factor
No matter how good an application or a computerized system is, human aspects also require attention, says Körber.
The personnel creating and managing the data need to work within a mature organizational culture to achieve integrity and compliance. While every organization wants to be aware and have effective controls in place, these on their own are no guarantee of competence.
“Only if a company applies policing and monitors execution for failure may it reach the final level of maturity: that of instinctively applying good practices constantly,” Körber points out.
A mature organization will also heed high pressure and will be able to learn from deviations by using ‘Critical Thinking’ to evaluate projects at all stages. Such an organization will investigate and successfully uncover root causes, demand accountability, and reward honesty.
Focus on data governance
However, every strategy has its limits. While data integrity controls help to prevent and detect fraud (which actually is a subset of all data integrity issues), even the best system cannot distinguish between a mistake (i.e. wrong data entered accidentally, e.g. a typo) and a fraudulent activity (i.e. wrong data entered intentionally). This requires true data governance, defined by the UK’s Medicines and Healthcare Regulatory Authority (MHRA) as “…arrangements to ensure that data, irrespective of the format in which they are generated, are recorded, processed, retained and used to ensure the record throughout the data lifecycle.”
This requires new roles for data owners and data stewards to take care of tactical coordination and implementation for data integrity and implement data usage management and security policies.
The data owner, supported by the data steward, is also responsible for managing the data’s life cycle. This is an important aspect of data integrity by design, ensuring that each piece of data has a designated owner at any point in its life cycle, which in turn should be defined, based on the supported process. This needs to take into account that data may be transferred across multiple systems, and analyze the risks associated with such transfers.
Therefore a holistic approach including effective handover of data ownership responsibilities between roles is compulsory, says Körber.
“Although this may sound ambitious: one could argue that finally data integrity is nothing but ‘compliance reloaded’. It is rather the sum of all facets, the level of detail, and the stringency of a data integrity by design approach that is new. Most of its ingredients are usual suspects. However, the importance of data, its quality, and its integrity, cannot be overstated,” the article concludes.
Körber has also hosted a webinar on data integrity. The German language webinar Why Pharma 4.0 only leads to success with data integrity is free to watch online (see Resources) and covers all the key factors, including ALCOA+ principles, consistent data management, optimizing risk management, identifying data lifecycles, and regulatory authority requirements.
About Körber Business Area Pharma
Körber is an international technology group with around 10,000 employees and more than 100 locations worldwide.
We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire.
At the Körber Business Area Pharma we are delivering the difference along the pharma value chain with our unique portfolio of integrated solutions.
With our consulting services we support pharma manufacturers to optimize processes and digitize manufacturing. Utilizing profound knowledge of regulatory requirements, track & trace processes management, recipe optimization, validation strategy and execution, as well as augmented reality solutions in manufacturing, we unlock the potential of our client’s productivity.
Learn more at www.koerber-pharma.com
Click on Körber Pharma Why Pharma 4.0 only leads to success with data integrity for free online access to webinar.
Click on Körber Pharma State of the Art Data Integrity – A Critical Inventory to read original article.
Click on this link, to visit the Körber Pharma Data Integrity website.