Types of regulatory observations
Regulatory Inspection Focus
What is Data Integrity?
How important is Data Integrity?
Data integrity Clarifications (watch out for pitfalls!)
Data Integrity Observation Categories
Data Integrity Trends
Additional Points of Interest
Current Global Data Integrity Guidance (FDA, Health Canada, MHRA and WHO)
Understanding ALCOA with Case Studies:
What makes it Attributable?
What makes it “Legible”?
What are the requirements for “Contemporaneously Recorded”?
What are the requirements for “Original or True Copy”?
What are the requirements for “Accurate”?
Overview of ALCOA Principles
Review each of the ALCOA principles and considerations for data integrity
Provide both paper and electronic examples of each ALCOA principle
Discuss examples of data integrity issues for each ALCOA principle
Discussion of “Accurate” part of ALCOA
Focus on what the term “Accurate” really means in relation to GxP
Provide examples from regulatory guidance
Review how “Accurate” expands into GxP
Provide specific GxP examples of “Accurate” in the context of data integrity
Going Deep-Preparing the Right Plan
Developing a Strategic and Effective the Plan
Understanding Capabilities and the Universe of Risk
Understanding Motivators for Behavior
Going Long-Sustainable Programs
Self Audit and Metrics to Drive Performance
Connections that Matter
Going Wide-Global Strategies
Site DI Officers
Data Integrity Council
Questions and Answers
Review the various released and draft guidance documents for this topic
Discuss the kinds of records that make up an electronic audit trail
Look at the challenges and practical approaches, both to the actual review process and the method of documentation of that review
Data integrity examples will be discussed
Examples of data integrity issues will be presented
How were the issues were identified?
Mitigation measures required to reduce or eliminate data integrity risk
Measures to Detect Data Integrity Issues
Discuss approaches to detecting data integrity issues within your organization
Review data lifecycle and data flows to allow detection of data integrity issues
Controls necessary to prevent data integrity issues
Group participation in discussing data integrity challenges within their organizations
Common data integrity issues in Manufacturing
Strategies for prevention of data integrity issues
Remediation of data integrity issues
Regulatory applicability for qualification and CSV
Aspects of computerized systems (hardware, software, infrastructure, and operating environments)
How validation phases apply to different types of system development cycles (SDLC)
Roles and responsibilities
Assessing risk and determining scope of validation
More on electronic records and signatures and data integrity and respective automated and procedural controls
Understand the Data Integrity Lifecycle
What is data integrity?
What does data integrity lifecycle mean?
Learn the components of data integrity and how data moves throughout its lifecycle
What is Data Security?
What is Electronic Record/Electronic Signatures (ER/ES)?
What is electronic records?
What is electronic signatures?
When does ER/ES apply?
Learn the fundamentals of ER/ES and how it applies to laboratory data
Controls for Electronic Data
What are electronic data controls?
Where are data controls required?
Learn how to implement data controls
Apply controls to the various computer system platforms
Standards for Assessing Data Governance and Data Integrity
Simple Deficiencies In Process And Procedures Have Not Been Corrected Since FDA Began Identifying Them 15 Years Ago, Where To Look