Published Articles - Tunnell Consulting

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.

In Defense of the Anti-Generic

This article in Pharmaceutical Manufacturing quotes Tunnell’s Scott Myers on the role of authorized generics in today’s competitive generics marketplace.

Quality Culture: Getting it Right the First Time

“Minimum viable product” may work well for software, but pharma needs to get it right the first time, and develop a culture of quality,

“Minimum viable product” may work well for software, but pharma needs to get it right the first time, and develop a culture of quality, tied to metrics, and encouraging change where the work actually takes place. This article in Innovation Excellence quotes Tunnell’s Al Riles and Bob Johnson on defining the four components of a quality culture.

Integrating Technology Transfer and Facilities Startup for Biologics

The key to successful technology transfer and facility startup is in strong project management, and it may make all the difference.

Manufacturing’s True North: The Quality Compass

Biopharma needs to combine a “culture of quality” with value-added process improvements in manufacturing.