Introduction to the Course
- What will be covered in the Course
- Introduction to the teaching Team
- Roles of Quality Assurance and Quality Control defined and discussed
Regulatory Guidance for Data Integrity Quality Oversight
- Review of data integrity guidances: PIC/S, WHO, EMA, MHRA, GAMP Guide for quality assurance role in data integrity and data governance
- Building a framework for quality oversight for Data Integrity (DI) in a GMP analytical laboratory within the QMS
- How culture can impact data Integrity
- Identifying key QA roles in the Data Integrity programme
Knowing and Managing Data Integrity Risk
- Data Process Mapping for Paper and Computerised Processes in the laboratory
- Identifying risk to records and mitigating them
Case Study 1: Data Process Mapping
- Review of data process maps for paper and hybrid process
- Identification of record and data integrity risks
- Proposals for risk Mitigation
- Course feedback and discussion
Role of Quality Assurance in Control of Master Templates and Blank Forms
- Overview of regulatory guidance for blank forms – 1993 to date
- Process flows for master templates and blank form use
- Identifying the QA role in the process
- Look at alternative options from paper
Raising Data Integrity Concerns
- Process for handling concerns outlined
- Confidentiality of the people and process
- How to handle whistle blowers
Recap of Day 1 and Introduction to Day 2
Case Study 2: Handling Data Integrity Concerns
- How should a concern be raised and to whom?
- How will the matter be kept confidential?
- Generating a high-level scope and action plan
Overview of Data Integrity Audits and Investigations
- Regulatory guidance
- Approaches for DI audits – computer system inventories, paper processes and critical data identified
- Preventing overlap with computer system periodic Reviews
- Dealing with data integrity violations: the DI Investigation
Case Study 3: Identifying Data Integrity Audit Priority and Frequency
- From a list of processes and systems attendees will identify the priority order of processes and systems to be audited
- From the priority, the audit schedule will be developed
- Frequency of DI audit of critical systems and paper processes
Case Study 4: Developing the Data
- Integrity Audit Coverage
- Scope of the data integrity Audit
- What will you audit?
- How will you audit a computerised system vs. a paper process?
Case Study 5: Data Integrity
- Investigation – Determining the Scope
- A data integrity violation has been found during a data integrity audit and an investigation is to be launched
- In a facilitated discussion, the course will define the scope and boundaries of the Investigation
Case Study 6: Data Integrity
- Investigation – Findings, Root Cause and CAPAs
- A list of findings from the investigation will be given and attendees must determine if they are poor data management errors or falsification
- Identification of the root cause
- What are the CAPAs: immediate fixes and long-term remediation Actions?
Key Learning Points