Using the QTA to Align Data-Integrity Expectations
- March 2019
- Life Science Leader
The principles describe may be applied to both commercial and pre-commercial stages of the product lifecycle.
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 Data Integrity Is Impossible Without A Quality Culture
- February 2019
- Pharmaceutical Online
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
- December 2018
- Journal of Pharmaceutical Innovation
Julia O’Neill co-authors article for Journal of Pharmaceutical Innovation.
Startups, Cloud Storage, & Data Integrity: Don’t Let This Happen To You!
- December 2018
- Pharmaceutical Online
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
- October 2018
- BioProcess Online
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
- October 2018
- Cell and Gene
Tunnell’s Julia O’Neill discusses statistics, chemical engineering and the curse of dimensionality.
Data Integrity Deviations and Shop Floor Quality
- June 2018
- Pharmaceutical Online
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
- June 2018
- Contract Pharma
Walter Matzmorr discusses the cross functional process of planning for a Pre-Approval Inspection.
Using Lean Strategy to Improve Efficiency in Pharmaceutical QC Labs
- March 2018
- Bioprocess Online
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
- March 2018
- Pharmaceutical Online
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
- March 2018
- Life Science Leader
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
- March 2018
- Bioprocess Online
Tunnell Principal, Kati Abraham, explains the importance of early regulatory engagement.