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.

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

June 2019 – 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.

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

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

Using the QTA to Align Data-Integrity Expectations

Mar. 2019 – The principals described may be applied to both commercial and pre-commercial stages of the product lifecycle.

Why Data Integrity Is Impossible Without A Quality Culture

Feb. 2019 – 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

Dec. 2018 – Julia O’Neill co-authors article for Journal of Pharmaceutical Innovation.

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

Dec. 2018 – Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value.

Why Biopharma Startups Need Organizational Effectiveness

Nov. 2018 – Maryann Gallivan discusses the elements of an effective organization.

Data (Integrity) Pirates: Preventing And Detecting Malicious Intent

Oct. 2018 – Tunnell’s Kip Wolf addresses the question: How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?

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

Oct. 2018 – Tunnell’s Julia O’Neill discusses statistics, chemical engineering and the curse of dimensionality.

PAI Readiness – A Journey, not an Event

Jun. 2018 – Tunnell’s Walter Matzmorr discusses the cross functional process of planning for a Pre-Approval Inspection.

Data Integrity Deviations, and Shop Floor Quality

Jun. 2018 – Kip Wolf explains why there is no “quick fix” for improving data integrity and data quality–it remains a journey of continuous improvement.

Also Read it at:
Bioprocess Online
Outsourced Pharma

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

Mar. 2018 – Julia O’Neill discusses current practices for specification-setting in the pharmaceutical industry.

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

Mar. 2018 – Tunnell’s Kip Wolf explains how firms that create and manage electronic documents can improve compliance.

Using Lean Strategy to Improve Efficiency in Pharmaceutical QC Labs 

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

Why You Should Engage With Regulatory Early in Product Development 

Feb. 2018 – Tunnell Principal, Kati Abraham, explains the importance of early regulatory engagement.

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

Jan. 2018 –  Tunnell Managing Consultant, Kip Wolf, discusses observations of CGMP violations involving data integrity.