ARTICLES BY KIP WOLF

  • Why Data Integrity Is Impossible Without A Quality Culture
    Why Data Integrity Is Impossible Without A Quality Culture

    For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

  • Startups, Cloud Storage, & Data Integrity: Don’t Let This Happen To You!
    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, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

  • Data (Integrity) Pirates: Preventing And Detecting Malicious Intent
    Data (Integrity) Pirates: Preventing And Detecting Malicious Intent

    During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?” 

  • Data Integrity, Deviations, And Shop Floor Quality
    Data Integrity, Deviations, And Shop Floor Quality

    Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality.

  • Where EDMS Fails: Data Integrity Pitfalls To Avoid In Metadata For Life Science Products
    Where EDMS Fails: Data Integrity Pitfalls To Avoid In Metadata For Life Science Products

    When creating and managing electronic documents, document metadata deserves as much attention as document content. Firms that do so can improve compliance and even gain potential competitive advantage by realizing electronic documents (with appropriate metadata) as real business assets.

  • Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations
    Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations

    At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. It is incumbent upon us to enforce and reinforce basic CGMP and GDocP practices in our own laboratories and those of our suppliers

  • When And How To Implement Data Integrity Practices In The Product Development Lifecycle
    When And How To Implement Data Integrity Practices In The Product Development Lifecycle

    There remains a great deal of confusion in the life sciences industry as to how to implement practices to best ensure data integrity. This confusion frequently stems from the assumption that data integrity is something to “turn on” at a particular stage of the product development life cycle.

Kip Wolf

Kip Wolf

Kip Wolf is a principal at Tunnell Consulting, where he leads the data integrity practice. Wolf has more than 25 years of experience as a management consultant, during which he has also temporarily held various highly visible leadership positions at some of the world’s top life sciences companies. Wolf has temporarily worked inside the life sciences industry on two occasions, both during periods of significant transformational change: first inside Wyeth, pre-Pfizer merger; and, again inside Merck, post-Schering merger. In both cases he led business process management (BPM) groups: at Wyeth, in the manufacturing division; and, at Merck, in the research and development division. In January 2015 Wolf joined Tunnell Consulting, where he brings his product development program management experience to bear to improve the probability of successful regulatory filing and product launch. He also leads the data integrity practice at Tunnell and consults, teaches, speaks, and publishes regularly on topics of data integrity and quality systems. Wolf can be reached at Kip.Wolf@tunnellconsulting.com.