Data Integrity: FDA/EU Requirements and Implementation

Definitions, requirements and approaches for data integrity

• Definition of data integrity: ALCOA+
• The importance of data integrity for public health
• Main reasons for non-compliance
• Regulations and guidelines
• FDA’s inspection and enforcement strategy of Part 11
• Lessons from recent FDA Warning Letters and how to avoid them

Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11

• Objective, scope, current situation and future of Part11
• Requirements for electronic records
• Requirements for electronic and digital signatures
• Additional requirements from the PICS/EU Annex 11,
• Developing a gap analysis
• Upgrading existing or purchasing new systems:
• Six steps for implementation of Part11/Annex 11

Strategies to detect and avoid integrity issues

• Recruit, train and retain employees who will be responsible for ensuring data integrity
• Preventing data integrity issues: Going through details of ALCOA+
• Possible causes for data integrity breaches
• Understand system vulnerabilities, motivation and likelihood operators might compromise data
• Understand the company’s quality culture
• Understand high risks in the data lifecycle
• Learning from internal audits and FDA inspections

The Quality System as Prerequisite for Data Integrity

• Contributing factors to poor quality
• Consequences of poor quality systems
• Recommendations from the FDA
• Developing a Quality Culture
• ICH Q10 – The quality system for pharma industry
• Implementing key requirements: e.g., CAPA system, failure investigations,, training, audits
• Assessment of data integrity risks
• Steps for on-going improvement

Cost effective Validation of software and computer systems

• Selecting the right validation lifecycle model
• Going through examples of a complete computer system validation from beginning to end
• How risk assessments can help to determine the type and extent of validation
• Defining user requirements based on risk
• Vendor assessment and supplier agreements
• Testing and documenting installation
• Going through examples for OQ and PQ testing
• Maintaining the validated state

Definition and Handling of Raw Data

• Definition of Raw Data
• Examples of raw data
• Raw data for paper based and electronic systems
• Criteria for electronic raw data with paper print-outs
• Raw data management along the data lifecycle
• Changing of raw data
• Archiving of raw data from electronic and hybrid systems
• Going through examples

Good documentation practices to ensure data integrity

• Requirements for documentation ( ALCOA+)
• Documents that must be readily available
• Examples for good and bad documentation
• Good practices for paper and electronic data
• How to avoid common documentation mistakes
• The importance of global documentation
• Examples

Data Integrity Auditing: Internal and FDA inspections

• Going through a typical FDA inspection as a model for internal audit
• FDA’s new approaches to data integrity inspections
• Typical audit questions
• Identifying systems that must be audited based on risk
• Typical audit findings
• The importance of the exit meeting
• Writing a corrective and preventive action plan to fix data integrity audit findings