Published Articles

Tunnell’s subject matter experts have written a number of informative pieces. Here are a sampling of articles that have been published in leading industry publications.

eBook: Data Integrity on the Life Sciences

  • Sept 2019
  • Pharmaceutical Online
A collection of Data Integrity articles by Kip Wolf.

What Your Organizational Design Says About Your Commitment To Data Integrity

  • August 2019
  • Bioprocess Online
Kip Wolf discusses why quality is everyone’s responsibility.

AI, Data Integrity, & The Life Sciences: Let’s Not Wait Until Someone Dies

  • June 2019
  • Bioprocess Online
AI may offer greater capacity for manufacturing by reducing the potential for defects and accelerating product review release and disposition for shipping through supply

Why Biopharma Startups Need Organizational Effectiveness

  • May 2019
  • Life Science Leader
Maryann Gallivan discusses the elements of an effective organization.

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

  • May 2019
  • Bioprocess Online
Business managers and organizational leaders must consider how human behavior will impact their data integrity.

Using the QTA to Align Data-Integrity Expectations

  • March 2019
  • Life Science Leader
The principles describe may be applied to both commercial and pre-commercial stages of the product lifecycle.

Why Data Integrity Is Impossible Without A Quality Culture

  • February 2019
  • Pharmaceutical Online
By taking assessment of Quality Control maturity and making intentional plans for improvement, companies can realize transformative effects in the organization.

Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities

  • December 2018
  • Journal of Pharmaceutical Innovation
Julia O’Neill co-authors article for Journal of Pharmaceutical Innovation.

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

  • December 2018
  • Pharmaceutical Online
Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value.

Data (Integrity) Pirates: Preventing And Detecting Malicious Intent

  • October 2018
  • BioProcess Online
Tunnell’s Kip Wolf addresses the question: How can one prevent or detect malicious intent and its impact to data integrity?

The Central Role For Contract Manufacturers In Developing Control Strategy For Gene Therapy Products

  • October 2018
  • Cell and Gene
Tunnell’s Julia O’Neill discusses statistics, chemical engineering and the curse of dimensionality.

Data Integrity Deviations and Shop Floor Quality

  • June 2018
  • Pharmaceutical Online
Kip Wolf explains why there is no “quick fix” for quality – it remains a journey of continuous improvement.
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