Data Integrity and Documentation Excellence

This course addresses one of the most cited areas in inspections: documentation and data integrity.

Description

This course addresses one of the most cited areas in inspections: documentation and data integrity. It moves beyond theory to show how ALCOA+ must appear in real records, batch documentation, and electronic systems. Participants will see how shared passwords, backdating, and incomplete entries immediately undermine credibility. The module clarifies the practical relationship between paper controls and electronic record requirements, including Part 11 fundamentals. By the end, attendees understand how to design documentation systems that naturally withstand audit scrutiny and reduce the risk of integrity-related findings.

Agenda:

• ALCOA+ principles in practice
• Good Documentation Practices (GDP)
• Batch records and logbook controls
• Electronic records & 21 CFR Part 11 fundamentals
• Audit trails and system security
• Preventing backdating and unofficial records
• Designing documentation that withstands audits

Who This Training Is Designed For

• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Operations Departments
• Production Departments
• Regulatory Affairs Departments
• Validation Professionals
• Engineering Departments
• Compliance Specialists
• Training Managers
• Document Control Personnel

Course Director: Charles H. Paul

Charles H. Paul is the President of CHP Consulting LLC – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 25 years and has published numerous white papers on varies subject from project management and technical writing to regulatory compliance in the life sciences. The firm works with both domestic and international clients designing solutions for complex training and documentation issues within the life sciences.