Top Ten Data Integrity Traps:FDA's Recent Clarification on Guidance for Managing Data Integrity for Regulated Systems

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Is your manufacturing and lab data reliable?

Are you sure that it will pass muster with regulators?

Virtually every area of your operations depends on the integrity of your data. Validating an FDA-regulated system and maintaining it in a validated state will provide strong assurance that the data created, analyzed, processed, transferred or managed using the system will have integrity, which will be maintained throughout its life cycle. This includes structured data, such as found in database records, and unstructured data, such as documents, spreadsheets, slides, images, audio, video, and other types.

In recent years, FDA inspections and audits have uncovered many data integrity problems, which have been the subject of Form 483 citations and Warning Letters. In fact, the incidence of Warning Letters related to data integrity issues has risen sharply in the past ten years. Most of these are “unforced” errors, most often due to companies doing more work with fewer resources. The constraints on manpower have resulted in errors and mistakes that could easily be avoided.

If you want to lock down your systems to make sure data integrity issues will not creep in, you need to identify the most common, and often most critical gaps that can lead to serious data integrity problems.

The Top Ten Data Integrity Traps webinar will help you to understand where most data integrity problems occur and to create a plan of action enabling you to proactively detect, prevent and mitigate them. You’ll learn about 10 key areas to focus on to minimize, if not avoid, data integrity violations:

  1. Quality Culture
  2.  Batch Records
  3.  Manufacturing Floor
  4. Raw vs. Recorded Data
  5. Lab Equipment
  6. Analytical Documentation
  7. Document Control
  8. Lab Control Procedures
  9. Materials Management
  10. Personnel


In 1983, the FDA provided guidelines for validating regulated computerized systems, and very little has changed since that time, other than technology. The premise for compliance is demonstrating clearly and completely that a computer system does what it purports to do. This means developing a very detailed set of unique and testable functional requirements and creating a set of test scripts that will prove each requirement is met.

While the industry has been validating systems for several decades, recent findings by the FDA during the inspection of computerized and automated operations indicate that data integrity issues have been increasing sharply and continue to do so. FDA issued a guidance document in 2018 to clarify their thinking on data integrity and compliance.

This webinar will describe the approach to validation based on several key factors:

  • Size
  • Complexity
  • Business criticality
  • GAMP 5 category (e.g., COTS, configurable code, custom code)
  • Risk Assessment (if the system should fail)

The level and robustness of testing required will take into account all of these factors, as well as the value of the data that will be housed and/or processed using the system. The rationale for type and level of testing is documented in the Validation Plan.

In addition to a strong validation program, a company must have specific policies and procedures in place to support each system through its entire life cycle. Training and Organizational Change Management (OCM) will also be discussed, as key elements for supporting systems and data.

Why should you attend? 

  • Understand the guidelines clarifying the FDA’s position on data integrity, including how they should be interpreted and applied, and how FDA is currently enforcing them
  • Understand in detail the application of FDA’s guidelines for Computer System Validation (CSV), based on the System Development Life Cycle (SDLC) methodology
  • Learn how to apply GAMP 5 system categorization and system risk assessment concepts to the validation of computer systems regulated by FDA
  • Learn the best practices for maintaining a computer system in a validated state throughout its entire life cycle, including all data (structured and unstructured) housed and/or managed using the system
  • Learn about current trends in FDA compliance and enforcement as they relate to data integrity issues and citations
  • Learn about industry best practices that will lead to inspection readiness
  • Learn about the roles of data/system owners vs. data/system stewards, and the training, documentation and policies/procedures that will support their efforts

Areas Covered in the Session :

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), 
  • Good Clinical Practice (GCP))
  • Data Integrity (DI)
  • Data Governance (DG)
  • Governance Board
  • Validation Strategy, Planning, and Execution
  • System Risk Assessment and Management
  • GAMP 5 “V” Model and Software Categorization
  • 21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
  • Security, Access, Change Control, and Audit Trail
  • Criteria required to ensure data is created and maintained with integrity through its life cycle
  • Policies and Procedures to support CSV and DI assurance

Who will benefit:

All FDA-regulated industries:

  • Pharmaceutical
  • Biologicals
  • Medical Device
  • Tobacco
  • e-Liquid, Vapor and Cigar companies
  • Software vendors providing code to medical device companies for incorporation into their products

Specific Titles:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • Quality Control/Quality Assurance Managers and Analysts
  • Quality Auditors
  • Compliance Officers
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Directors, Supervisors, and other key personnel
  • Warehouse and Supply Chain Directors, Supervisors and other key personnel
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Clinical Data Managers and Scientists
  • Quality Managers, Chemists, and Microbiologists
  • Regulatory Affairs Personnel
  • Adverse Event and Post-Marketing Surveillance Specialists
  • Consultants in the Life Sciences, Tobacco and Related Industries

Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of products must understand and conform to FDA requirements for data quality and integrity.

Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.

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