Published Articles - Tunnell Consulting

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.

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

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

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

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

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

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

Information Management Strategies to Improve Data Integrity During M&As

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