Lab Data Integrity Conference & Workshop Audit Trail Review for Laboratory Systems
Im Auftrag der ECA Academy

Programm

Introduction – Laboratory Data Integrity: Where Are We Now?

• Overview of data integrity since October 2016 conference
• Warning letter update
• Regulatory guidance update
• GAMP Guide on Records and Data Integrity

Regulatory Requirements and Expectations

• Legal requirements, European and international guidelines and guidance documents
• Case study: data integrity in the quality control lab and how it relates to the continuous
• improvement process
• Inspection findings

Mitigating Data Integrity Risks in Pharmaceutical Manufacturing

• What is “data integrity”?
• What is “metadata”?
• What primary data integrity risks are associated with data systems (paper, electronic, and hybrid)? How can these risks be mitigated?
• How can manipulation of electronic records be detected?
• What are the requirements of/best practices for validating a computer system/
• electronic records?
• What are the most important things for companies to do or recognize regarding
• manufacturing data integrity?

Metrics for Laboratory Data Integrity

• What are metrics?
• Metrics will change throughout a data integrity programme: assessment and
• remediation phases
• Suggested metrics for routine chemical analysis

Case Study: Data Integrity from Research to Manufacturing: Balancing Analytical
Science and Regulatory Compliance

• Patient safety, freedom of research and speed to market: the dilemma of development
• DI in the development lifecycle – phase appropriate requirements
• Is it just regulations or common sense?
• The TITO principle and how to avoid it
• Benefits of data integrity measures
• Data ownership as a key prerequisite for DI compliance

Instruments with Integrated Software and Data Integrity

• The new USP <1058> and the Lab Instrument classes
• The class B and Data Integrity
• The hubris of hybrids – paper complicates everything!
• Criticality: how critical is critical?

Scope and Detail of a Second Person Review

• US and EU regulatory requirements for second person review
• Responsibilities and SOP for the review
• Key requirement for the review: objective evidence
• Paper record review
• Hybrid system review problems
• Electronic system set up – is the software up to the job?
• Assays where second person review can be problematic

Using Data Flow Mapping to Identify Data Integrity Concerns

• What is ‘Data Flow Mapping’?
• How to execute ‘Data Flow Mapping’?
• The benefits of ‘Data Flow Mapping’
• Examples of ‘Data Flow Mapping’ detecting data integrity concerns

Data Integrity: An Instrument Suppliers Perspective

• The extent to which all data are complete, consistent and accurate throughout the
• data lifecycle“ – the lifecycle starts at the beginning – at the source of the data
• It‘s about the controls throughout the whole process
• Common misconceptions of benchtop instruments
• Start with correct data – finish well.

Data Integrity Audits – An Analytical Perspective

• What to expect when preparing an audit for data integrity
• The analytical laboratory - from the clinical setting to the certified laboratory
• (50 shades of grey?)
• How to plan the audit (access to site, systems and records; length of audit, location
• of audit, etc.)
• Performing the audit (access to staff, access to systems and records - let the hunt begin!)
• From black holes to compliant records - where to draw the line?
• The audit report - explaining the unexplainable, the difficult and the obvious

Review of the GAMP Guide: Records and Data Integrity

• Overview of the new guide
• Review and Discussion of key sections of the Guide: Data governance framework
• Data life cycle, Risk management, Management, development and operation appendices

Laboratory Control Systems: how to prevent Data Integrity violations

• Strongly enforced Data Integrity Requirements in the latest 3 years by almost every
• Regulated Agency in the latest guidances issued by MHRA, WHO, FDA and recently
• by PIC/S.
• Particularly importance in the laboratory environment where data created within the
• analytical processes are relied upon to ensure the Product Quality
• Requirement to implement every control measure oriented to prevent Data Integrity
• violation either through automatic functionalities and interim manual procedures
• Need to routinely monitor the effectiveness of these measures in pharmaceutical
• companies

Post Conference Workshop Audit Trail Review for Laboratory Systems

Why Is An Audit Trail and Its Review Important?

• Part 11 and Annex 11 / Chapter 4 requirements for audit trail
• Regulatory requirements for audit trail review
• Guidance documents for audit trail review
• Do I really need an audit trail?

What is in a Name?

• What do we look for in an application for auditing?
• Pros and cons for event logs and audit logs?
• Audit trail(s) ?
• Part 11 compliant system - does this help data integrity?

Workshop 1: Which Audit Trail to Review?
Attendees will be presented with an overview of the audit trails within an application and
the content of each log. Which audit trails should be reviewed and when in the context
of the work performed by the laboratory data system?

What are GMP-Relevant Data?

• Annex 11 requires that audit trails monitor GMP-relevant data – what are GMP relevant data?
• Critical data?

Workshop 2: Identifying GMP Relevant Data
Attendees will be presented with a list of records to identify if they are GMP records and
how critical they are to help focus the second person review of audit trail data.

Review of Audit Trail Entries

• What are we looking for in an audit trail review?
• Process versus system: avoiding missing data integrity issues
• Regulatory requirement is “frequent review” of audit trails
• What do we need to validate and what to check?
• Suspected data integrity violation - What do we need to do?

Workshop 3: Reviewing Audit Trail Entries
Attendees will be provided with the output of an audit trail to review and see if any
potential issues are identified for further investigation.

• Controls to Aid Second Person Review of Audit Trails
• Procedural controls for data review
• Technical considerations for audit trail review e.g. Identifying data that has been changed or modified – how the system can help, Documenting the audit trail review has occurred
• Review by exception – how technical controls can help
• Have you specified and validated these functions?