ARTICLES BY KIP WOLF
Attributable Data Integrity in Modern Biopharma Using ALCOA Principles8/29/2022
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
The Data Integrity Body of Knowledge Expands with New & Pending Guidances12/20/2021
Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.
Data Integrity In Supply Chain Risk Management During Zero Trust6/21/2021
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.
Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity?10/12/2020
Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.
Canaries In A Coal Mine: Can Data Integrity Thwart A Deepfake Threat?7/15/2020
If you think deepfake security risks are purely science fiction, think again. Not only does the technology exist and the content is readily available to facilitate such activities, but incentives to carry them out are multiplied in the current economic, social, and political environment.
Data Integrity In A Cloud-Based World: Regulations & Best Practices5/11/2020
There was a time when cloud computing was thought of skeptically by the life sciences community, through both the critical observations that are typical of science-based industry and the ingrained cultural resistance to change that comes along with a heavily regulated environment. But today, cloud solutions are ubiquitous in the industry.
Implementing Data Quality By Design For Improved Data Integrity4/1/2020
We must adopt more planning in our data quality activities. This is data QbD in its simplest explanation, and we must include data integrity planning in those activities (e.g., considering how to meet ALCOA requirements).
People: The Most Persistent Risk To Data Integrity11/15/2019
HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.
What Your Organizational Design Says About Your Commitment To Data Integrity8/8/2019
Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.
AI, Data Integrity, & The Pharma Industry: Let’s Not Wait Until Someone Dies6/18/2019
Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.