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.

• 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.

• What Your Organizational Design Says About Your Commitment To Data Integrity

  8/8/2019

  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 Life Sciences: Let's Not Wait Until Someone Dies

  6/18/2019

  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.

• To Err Is Human: Contextual Communication's Impact On Data Integrity

  5/8/2019

  Despite the best efforts of those responsible for data integrity, the potential for human error is directly and indirectly impacted by the corporate, the national/regional , and quality culture of an organization.

• Why Data Integrity Is Impossible Without A Quality Culture

  2/19/2019

  For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

• Startups, Cloud Storage, & Data Integrity: Don't Let This Happen To You!

  12/5/2018

  Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

• Data (Integrity) Pirates: Preventing And Detecting Malicious Intent

  10/22/2018

  During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?” 

• Data Integrity, Deviations, And Shop Floor Quality

  6/15/2018

  Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality.