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Academy Program of 6 sessions
"Understanding Data Integrity and how to approach it in the chromatography lab"
The Academy offers a series of 6 webinars focused on Data Integrity. The objectives are to provide the tools for identifying and approaching the Data Integrity gaps in regulated laboratories. For anyone working under GXP and quality standards such as ISO 17025.
Through the 6 sessions, Mr. Mc Dowall will take us through the concepts of data integrity and data governance and provide sound recommendations thanks to a large experience in the industry as auditor and consultant. see below more information about our presenter Mr. Mc Dowall.
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Data Integrity Focus, Part I: Understanding the Scope of Data Integrity
Data integrity requires more than just ensuring that the calculated numbers of analysis are complete, consistent and accurate. There is much more to consider. The full scope of data integrity and data governance program can be presented and explained in a simple diagram.
In this session, we´ll look at a four-layer data integrity model to cover the whole scope of a data integrity program. The layers are interactive; ensuring data integrity depends on a foundation of data governance, qualified analytical instruments, and validated software with properly developed and validated robust analytical procedures. In the next session of this series, we will look at a way of identifying data integrity vulnerabilities in paper processes and computerized systems.
Data Integrity Focus, Part II: Using Data Process Mapping to Identify Integrity Gaps
Understanding and mitigating risks to regulatory records is an important part of a data integrity program. We discuss data process mapping as a technique to identify data gaps and record vulnerabilities in a chromatographic process and look at ways to mitigate or eliminate them.
In this session, we´ll look at a simple and practical methodology that can be applied to identify the risks with any process in a regulated “good practice” (GLP) laboratory. Once identified, the risks can be mitigated or eliminated to ensure the integrity of data and records. The methodology is called data process mapping, and it is a variant of process mapping, which might be familiar to whom has already been involved with implementation of a computerized system or six sigma improvement projects.
Data Integrity Focus, Part III: What is the Problem with Hybrid Systems?
Regulatory Authorities globally have concerns about hybrid computerized systems. These are the worst possible computerized system to have in your laboratory from a regulatory perspective. Here, we discuss what a hybrid system is and explain why there is such a fuss about them.
In this session, we´ll define what a hybrid system is, and understand why it is not recommended by regulatory authorities. The biggest problem with hybrid systems is the synchronization of two incompatible media. However, the hybrid problem is too often perpetuated by suppliers, who do not design software for electronic working and data acquisition directly to a network storage area. The problem is compounded by laboratories that keep purchasing applications with inadequately designed compliance functions to give data integrity assessors a job for life.
Data Integrity Focus, Part IV: Are Raw Data and Complete Data the Same?
European Union (EU) good manufacturing practice (GMP) in Chapter 4 on Documentation uses the term raw data but does not define what it means. US GMP uses the term complete data when referring to laboratory records. Confused?
We explore the two terms, and ask if they mean the same thing? Could this be regulatory harmonization by different terms?
We´ll look at the EU GMP Chapter 4 and interpret the term raw data by using the definition from US GLP regulations. We´ll understand what complete data mean in a GMP laboratory. We´ll be able to demonstrate that raw data and complete data are equivalent and show what this means in practice for a chromatographic analysis.
Data Integrity Focus, Part V: How Can USP <1058> Help Data Integrity?
The updated version of United States Pharmacopoeia (USP) <1058> on analytical instrument qualification (AIQ) merges instrument qualification and computer validation into a single integrated process. We need to understand how the new version of USP <1058> can help ensure data integrity of a chromatography data system (CDS).
We´ll focus on the requirements of the updated USP <1058> on analytical instrument qualification and how it can help with ensuring the integrity of data generated by a chromatography data system. In the sixth and last session of this series on data integrity, we will look at the people who will be policing and providing oversight of the whole data integrity process. Enter stage left, those intrepid people from quality assurance.
Data Integrity Focus, Part VI: Who Is Looking Over Your Shoulder? Quality Oversight for Data Integrity
The focus of this series so far has been on the chromatography laboratory. In this last part, we look at the roles and responsibilities of quality assurance staff for ensuring data integrity in an organization.
Quality oversight is an important component of an overall data integrity program within any regulated organization, to ensure that work has been performed correctly. Where problems have been identified, there need to be preventative, and corrective plans put in place. In the case of a data integrity violation, quality assurance needs to conduct a thorough and detailed investigation that will determine the extent and impact of any falsification, and determine if there is any material impact on a regulatory submission, product quality, or patient safety.
Dr. BOB MCDOWALL, Director, R D McDowall Limited, Bromley, Kent, UK
An analytical chemist with over 45 years experience including 15 years working in the pharmaceutical industry and over 25 years working for the industry as a consultant. Bob has been involved with automating analytical laboratories since 1980 and was an early implementer of a Laboratory Information Management System (LIMS) and the experience gained allowed him to edit the first book on the subject in 1988. Bob was presented with the 1997 LIMS Award by the LIMS Institute for advances in the subject and teaching.
Bob is an auditor and he has been involved with the validation of computerized systems for over 30 years and is the author of books on the Validation of Chromatography Data Systems (two editions 2005 and 2017) and this year published his book on Data Integrity and Data Governance - Practical Implementation in Regulated Laboratories.
Bob is also the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several Journals. He is also involved in the GAMP Data Integrity Special Interest Group and is a contributor and reviewer of the 2017 GAMP Guide for Records and Data Integrity and the Good Practice Guide on Data Integrity - Key Concepts.
Last edition: Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories Royal Society of Chemistry 2019
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