Why is Data Integrity Important? – Setting the Scene
- Summary of falsification observed by FDA and EU inspectors 2005 – to date
- FDAISA act 2012 and October 2014 Guidance for Industry and the impact on inspections
- Inspection of computerised systems is changing: from paper to on-line
- MHRA expectation for data governance; data integrity guidance documents 2016
- FDA Level 2 guidance on data integrity: 2010 and 2014 postings
- Impact of WHO guidance for data integrity
Data Integrity – EU GMP Requirements
- EU GMP Chapter 4 – documentation
- EU GMP Annex 11 computerised systems
- Data integrity definitions
- Difference between paper and electronic systems
Principles of Data Integrity
- The ALCOA+ criteria for data integrity
- Data life cycle in the process workflow – managing controls
- Paper versus hybrid versus electronic systems
- Validation of computerised systems for data integrity controls
- Scope: production information versus laboratory data: why are laboratory data higher risk?
Facilitated Discussion / Workshop on Key Data Integrity Topics
- Recording results on paper
- Configuration of software applications
- Unique user identities for all users
- Unauthorised access
- Appropriate access privileges for each user role
- Is my chromatographic system ready? Role of “test” injections
- Audit trails – options for older systems
- Manual chromatographic integration
- Standalone versus network systems
- Protecting electronic records of standalone systems
WHO, MHRA and GAMP Data Integrity Guidances - Key Points
- Data Governance System within the Pharmaceutical Quality System
- Data Life Cycle
- Spectrum of Systems: Paper to Electronic Systems with data integrity audit
- The GAMP Records and Data Integrity Guide
FDA Draft Guidance for Industry ‘Data Integrity and Compliance with cGMP’
- Background
- Questions and Answers regarding Data Integrity
Role of Management in Data Integrity
- Role of Senior, Production and Department Management in ensuring data integrity within an organisation and its suppliers
- Data governance within a Quality System
- Failures to address poor data integrity practices and no training
Development and Scope of a Data Governance System
- Within a PQS, what is the scope of a data governance system?
- Who are involved?
- What are their roles?
Implementing Data Integrity Training
- Scope of data integrity training
- What cover in the training?
- Checking training effectiveness
- Integrating data integrity training with GMP training
Workshop: Analysis of an FDA Warning Letter
- Working in teams, attendees will analyse one of several FDA warning letters to identify key areas of regulatory concern
- Group discussion of regulatory concerns identified
US 21 CFR 211 and EU GMP Chapter 4: Complete data vs raw data vs primary record
- Why complete data and raw data are important for understanding data integrity
- EU GMP Chapter 4 requirements for raw data
- 21 CFR 211 requirements for laboratory records: complete data
- FDA Level 2 guidance: paper versus e-records
- Complete data / raw data / primary record example
Case study: Data Integrity questions as part of an inspection
- Lab System
- QA System
- Manufacturing System
Workshop: How to write testable requirements for Data Integrity
- Access control
- Archiving
- Technology constraints
Data Integrity in paper documentation
- GMP requirements for good documentation practice
- Application to paper documents
- Common problems from FDA 483 observations and warning letters and how to avoid them
User Account Management and Application Configuration
- Separation of roles and responsibilities between IT and the business
- Documentation of the configuration of an application e.g. audit trail, user types and access privileges
- User account management: the dos and don’ts
- User identities must be unique
- Regular review of each system users and privileges
IT Support for Data Integrity
- IT facilities, environmental controls and physical security
- Qualified IT infrastructure and validated IT systems
- Backup and recovery / Change control
- IT support including database administration
- Impact of IT infrastructure on data integrity
Software Suppliers Responsibility for Data Integrity Compliance
- Regulatory requirements for software systems: procedural and technical
- Role of software suppliers
- Regulations push v market needs pull
- Implementing technical requirements for software: architecture, database and application
- Marketing literature versus marketing bullshit
Workshop: Assessing a System for Data Integrity
- Using a checklist based on the data integrity criteria, attendees will assess a system for data integrity
Case study: Can Spreadsheets meet Data Integrity requirements?
- Problems with spreadsheets
- Good Practice for using spreadsheets in a regulated environment
- Building data integrity features into a spreadsheet
Supply Chain Data Integrity – Organisational Interfaces
- Approaches to ensuring data integrity of your suppliers
- Role of technical agreements and audits
Key Learning Points and Final Discussion
- Summary of Data Integrity Requirements and Key Learning Points
- Final Discussions and close of the course