Published Articles - Tunnell Consulting

What Your Organizational Design Says About Your Commitment To Data Integrity

Kip Wolf discusses why quality is everyone’s responsibility.

Forbes.com: New to Business Development? 10 Hot Industries to Join Right Now

Tunnell CEO, Maryann Gallivan, is quoted in Forbes.com about the appeal of the life sciences industry for new graduates

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

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

AI may offer greater capacity for manufacturing by reducing the potential for defects and accelerating product review release and disposition for shipping through supply chain.

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.