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.

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.

PAI Readiness – A Journey, Not an Event

  • June 2018
  • Contract Pharma
Walter Matzmorr discusses the cross functional process of planning for a Pre-Approval Inspection.

Using Lean Strategy to Improve Efficiency in Pharmaceutical QC Labs

  • March 2018
  • Bioprocess Online
Tunnell Consultants Greg Anthos and Scott Myers explain how a company reduced its 15-day throughput time by 30% within 3 months.

Where EDMS Fails: Data Integrity Pitfalls to Avoid in Metadata for Life Sciences Products

  • March 2018
  • Pharmaceutical Online
Tunnell’s Kip Wolf explains how firms that create and manage electronic documents can improve compliance.

Losing Sight of the Intended Purpose of Specifications Has Consequences for the CMO-Sponsor Relationship

  • March 2018
  • Life Science Leader
Mar. 2018 – Julia O’Neill discusses current practices for specification-setting in the pharmaceutical industry.

Why You Should Engage With Regulatory Early in Product Development

  • March 2018
  • Bioprocess Online
Tunnell Principal, Kati Abraham, explains the importance of early regulatory engagement.

Cheating In The Lab: 3 Data Integrity Pitfalls to Avoid in Laboratory Operations

  • January 2018
  • Bioprocess Online
Tunnell Managing Consultant, Kip Wolf, discusses observations of CGMP violations involving data integrity.

Information Management Strategies to Improve Data Integrity During M&As

  • November 2017
  • Life Science Leader
Tunnell Managing Consultant, Kip Wolf, discusses the challenges to M&A integration and maintaining business continuity, transferring appropriate knowledge, and transferring information assets.
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