Resolving Quality and Compliance Challenges in a GxP World
Published Guides, Books and Whitepapers
Article: APAC Pharmaceutical Landscape
Article: APAC Pharmaceutical Landscape
Article: APAC Pharmaceutical Landscape
A comprehensive overview of APAC based on interviews and information provided by key ISPE leaders in the region including Charlie. Published in the March/April 2024 edition of Pharmaceutical Engineering, the article is available to ISPE members.
ISPE GAMP 5 Second Edition
Article: APAC Pharmaceutical Landscape
Article: APAC Pharmaceutical Landscape
Charlie was a Chapter lead on GAMP 5 Second Edition and substantially revised the appendices M4 Categories of Software and Hardware to better promote risk-based approaches, and D5 Testing of Computerized Systems to incorporate critical thinking, CSA and additional test types and approaches.
ISPE GAMP 5 Second Edition can be purchased from the ISPE Bookstore.
Article: GAMP 5 Update
Article: APAC Pharmaceutical Landscape
ISPE GAMP Enabling Innovation
Article in European Pharmaceutical Review, November 2022:
"GAMP 5 update: computerized system expectations for pharma manufacturers"
by Lorrie Vuolo-Schuessler, Stephen Ferrell, and Charlie Wakeham.
The article is free to read on the EPR website.
ISPE GAMP Enabling Innovation
Building Data Integrity into your Quality System Whitepaper
ISPE GAMP Enabling Innovation
In the Enabling Innovation good practice guide, Charlie led a team of fellow GAMP SMEs in examining in detail the role of critical thinking throughout the computerized systems lifecylce and all the benefits it can bring.
The ISPE GAMP Enabling Innovation guide can be purchased from the ISPE Bookstore.
Critical Thinking Not Categorization Whitepaper
Building Data Integrity into your Quality System Whitepaper
Building Data Integrity into your Quality System Whitepaper
Long before working on GAMP 5 Second Edition, Charlie was already highlighting the limitations of a category-based approach and instead promoting the application of critical thinking in computerized systems validation, as detailed in this 2021 whitepaper written for Waters.
Image copyrighted to Waters Corporation 2021
The whitepaper is available for free download from the Waters website.
Building Data Integrity into your Quality System Whitepaper
Building Data Integrity into your Quality System Whitepaper
Building Data Integrity into your Quality System Whitepaper
In the Waters whitepaper "Building Data Integrity into your Quality System", Charlie discusses common threats to data integrity, and the need for strong governance, knowledge management and quality risk management to provide assurance that data is available and trustworthy at all times.
Image adapted with permission from ISPE GAMP Data Integrity by Design guide.
The whitepaper is available for free download from the Waters website.
ISPE GAMP Data Integrity by Design
ISPE GAMP Data Integrity by Design
ISPE GAMP Data Integrity by Design
Charlie, Lorrie Vuolo-Schuessler, and James Henderson led a team of industry volunteers in creating a comprehensive guide to using process mapping and data flow diagrams to design in data integrity across multiple data and system lifecycles. This guide also contains the first formal publication of material on Computer Software Assurance.
ISPE GAMP Data Integrity by Design guide can be purchased from the ISPE Bookstore.
St. Gallen Quality Control Lab
ISPE GAMP Data Integrity by Design
ISPE GAMP Data Integrity by Design
This book was an initiative from the University of St. Gallen in Switzerland, bringing together industry experts to share case studies and operational excellence examples.
Charlie led a small team of GAMP SMEs to create the chapter "Building Data Integrity into Lab Working Practices".
This St. Gallen book was published in 2020 and can be purchased from Amazon.
Durable Data Whitepapr
ISPE GAMP Data Integrity by Design
ISPE GAMP Data Integrity - Manufacturing Records
The Durable Data whitepaper, written by Charlie, Dr. Cody Wright, and Richard Cheng, explains the differences between backup / restore and archiving, and the need for both. It provides helpful tips on avoiding data loss from the Empower Chromatography Data System and discusses the benefits and possible weaknesses in cloud deployments.
Image copyrighted to Waters Corporation 2020
The whitepaper is available for free download from the Waters website.
ISPE GAMP Data Integrity - Manufacturing Records
ISPE GAMP Data Integrity - Manufacturing Records
ISPE GAMP Data Integrity - Manufacturing Records
Published in 2019, and led by Charlie and Lorrie Vuolo-Schuessler this guide focused on the challenges of data integrity through complex manfuacturing systems, including process control systems and MES.
The ISPE GAMP Data Integrity - Manufacturing Records guide is available to purchase through the ISPE bookstore.
ISPE GAMP Data Integrity - Key Concepts
ISPE GAMP Data Integrity - Manufacturing Records
ISPE GAMP Records and Data Integrity Guide
The Key Concepts guide author team was led by Charlie and Lorrie Vuolo-Schuessler. This guide looked at the cultural implications on data integrity, explored the need for data classification, and examined the interrelationships between data lifecycles and system lifecylces.
The ISPE GAMP Data Integrity - Key Concepts guide is available to purchase through the ISPE bookstore.
ISPE GAMP Records and Data Integrity Guide
ISPE GAMP Data Integrity - Manufacturing Records
ISPE GAMP Records and Data Integrity Guide
This first data integrity guide from GAMP introduces the data lifecycle and explains the need for data governance in support of data integrity. Charlie wrote the sections examining the impact of geographical and corporate culture.
The ISPE GAMP Records and Data Integrity guide is available to purchase through the ISPE bookstore.
ISPE GAMP A Risk-Based Approach to Testing of
ISPE GAMP A Risk-Based Approach to Operation of GxP Computerized Systems
ISPE GAMP A Risk-Based Approach to Operation of GxP Computerized Systems
Having contributed content to the First Edition of this guide, published in 2005, Karen Ashworth and Charlie were delighted to be asked to lead the creation of the Second Edition, published in 2012.
The Testing Guide is available to purchase through the ISPE bookstore.
ISPE GAMP A Risk-Based Approach to Operation of GxP Computerized Systems
ISPE GAMP A Risk-Based Approach to Operation of GxP Computerized Systems
ISPE GAMP A Risk-Based Approach to Operation of GxP Computerized Systems
Validating a new computerized system is an achievement; maintaining it in a validated state throughout its operational life is an ongoing challenge. Charlie was a contributing author to this 2009 guide detailing the framework of controls and processes needed
The Operations guide is available to purchase through the ISPE bookstore.
ISPE GAMP A Risk-Based Approach to Operation of GxP Computerized Systems