ARTICLES BY KIP WOLF

• Attributable Data Integrity in Modern Biopharma Using ALCOA Principles

  8/29/2022

  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 Guidances

  12/20/2021

  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 Trust

  6/21/2021

  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 Practices

  5/11/2020

  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 Integrity

  4/1/2020

  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 Integrity

  11/15/2019

  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.

• Using The QTA To Align Data-Integrity Expectations

  4/17/2019

  Outsourced GMP-regulated activities have clear requirements, including the use of quality-technical agreements (QTAs). The principles described in this article may be applied to both commercial and precommercial stages of the product life cycle and to any relationship with suppliers that provide outsourced GMP-regulated activities.