Part 2: Self Inspections and Audits to Confirm Effective Data Integrity Controls
Data Integrity Self Inspections and Audits for Hybrid and Electronic Systems
- Data Integrity audits of computerised systems
- Understanding the data life cycle of the system to be audited
- Validated system can have data vulnerabilities
- Presentation and discussion of the Data Integrity audit checklist
WORKSHOP I:Risk Assessment and Prioritisation
- So much to do but so little time – risk management in practice
- When conducting a Data Integrity audit which areas within a pharmaceutical quality system will be the focus?
- Feedback and discussion with the teaching team
WORKSHOP II:FDA Key Laboratory Data Integrity Concerns
- Working in teams, attendees will analyse FDA warning letters to understand the regulatory concerns.
- Discussion and feedback session with the teaching team
WORKSHOP III:Spreadsheet Auditing
- Working in groups attendees will be given a printout of a spreadsheet
- What questions need to be asked to determine if there is sufficient Data Integrity and control?
- Feedback and discussion with the teaching team
WORKSHOP IV:Hybrid Systems Auditing
- A laboratory system is used in hybrid mode
- What questions should the auditor ask to determine if there are any Data Integrity problems?
- Feedback and discussion with the teaching team
WORKSHOP V:Audit Trail of Electronic Systems and Electronic Signature Auditing
- Review of audit trail entries is a key Data Integrity requirement of Annex 11
- Attendees will review the printout of an audit trail to determine if there any Data Integrity issues to be raised?
- Use of electronic signatures can mask some Data Integrity issues
- Can the attendees find what those issues are?
- Feedback and discussion with the teaching team
WORKSHOP VI: Preparing for the Data Integrity Audit
In the first of three linked workshops, attendees will be given a laboratory scenario to answer the following questions:
- What will be the composition of the audit team?
- What will be their skills?
- What will be the duration of the audit?
WORKSHOP VII: Observations and Findings during a Laboratory Audit and planning the Closing Meeting
- Each team will be provided with an audit of a laboratory with observations
- Teams will determine if there are any Data Integrity non-compliances with the regulations and laboratory procedures
- Teams will determine if any observations are findings (non-compliances) and grade the severity of each one
- Prepare for the closing meeting with the Head of the Laboratory and the business process owner of the systems
WORKSHOP VIII: Feedback to the Auditees
- Teams will present the audit conclusions and the findings to the Head of the Laboratory and the business process owner of the systems
- Discussion with the auditees of the findings