Data Integrity Principles
- Basements of Data Integrity
- Guidelines
- Implementation of Data Integrity Standards at a Site (Praxis example)
- CARs Model (Critical Application Risks) – an implementation model based on Quality Risk Management
Current Inspection Observations and their Potential Resolution
- Examples from current inspections
- Potential CAPAs on observations
- Watch-Outs and defense packages
- Inspectors expectations from different authorities: FDA, ANVISA, MHRA, German MoH …
Why is Control of Blank Forms Important?
- Instructions and blank forms – Life cycle and Data Integrity considerations
- FDA requirements for control
- Process for creation of master templates
- Process for operational use of blank forms
- Reconciliation mechanisms
Facilitated Discussion: Control of Templates and Blank Forms
Records – Life Cycle and Data Integrity Issues
- GMP Record Lifecycle
- Control Mechanisms
- Data Integrity for physical vs. electronic records
- How to manage record copies without violating Data Integrity rules?
Advantages and Disadvantages of Document Management Systems: Paper Based - Hybrid – Electronic
- Paper archives - cheap and secure?
- Requirements for an eDMS
- eDMS server-based solution vs. SaaS in the cloud
- How to transfer paper documents into electronic records?
Electronic Document Management and Change Control Systems to Ensure Data Integrity
- Data Integrity expectations on an Electronic Document Management System (EDMS) and Change Control System
- Audit Trail Review / Log File Review
- Fundaments of a modern EDMS
- Traceability
- Mapping ALCOA principles on EDMS and Change Control
- Expectations from inspections
Data Integrity and Digital Signatures
- What exactly is an electronic signature?
- Advanced vs qualified digital signature
- Technical implementation
- Change of workflows
- Parallel processes
- How to manage replacements
Handling Hybrid Records: Good Documentation Practices for Linked Paper and Electronic Records
- Chapter 4 and 21 CFR 11 regulations for linking signatures to electronic records
- Are you saving the underlying electronic record?
- Checks and technical controls to ensure the signature are linked to the record
- Common pitfalls in record-signature linking
Second Person Review of Batch and Analytical Records: Paper, Hybrid and Electronic Formats
- Importance of a second person review for Data Integrity
- What will a reviewer review with paper, hybrid and electronic records?
- Training for second person review
- Detection of poor documentation practices and falsification
- Risk-based second person reviews of records and audit trails
Workshop: Design of a Document Control SOP
How to Train Staff in Good Documentation Practice and Data Integrity
- Pre-requisites: Data Integrity policy with effective training
- Procedure for good documentation practices is essential
- Options for training: read and understand, instructor led training (ILT) and ILT with check for understanding
Data Integrity: Praxis Example of Implementation of the Requirements at a Pharma Site Based on Quality Risk Management Principles
Typical Documentation Failures and how to Avoid them – Key Learning Points
- Analysis of FDA 483 and warning letter citations for poor documentation practices
- Identification of top 5 documentation failures
- Ways to avoid them e.g. through changes in working practice, training and technical controls
Management and Control of Multilingual Documents (Data Integrity Expectations)
- Part 1: Basics
- Workbench
- Translation
- Synchronisation
- Part 2: Implementation and management
- Responsibilities
- GMP status
- Versions
- Signatures
- Change Control