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.

Why Biopharma Startups Need Organizational Effectiveness

Maryann Gallivan discusses the elements of an effective organization.

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

Business managers and organizational leaders must consider how human behavior will impact their data integrity.

Julia O’Neill discusses statistics, chemical engineering and the curse of dimensionality

Using the QTA to Align Data-Integrity Expectations

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

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

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

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

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

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

Tunnell’s Julia O’Neill discusses statistics, chemical engineering and the curse of dimensionality.

Data Integrity Deviations and Shop Floor Quality

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

Walter Matzmorr discusses the cross functional process of planning for a Pre-Approval Inspection.

Using Lean Strategy to Improve Efficiency in Pharmaceutical QC Labs

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