Dr. Bob McDowall
R.D. McDowall Ltd.
Referent:innen
Dr. Markus Dathe
F. Hoffmann-La Roche
Dr. Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
All times mentioned are CEST.
Zielsetzung
The objectives of this Live Online Training are:
- To provide an understanding of the regulatory requirements for Audit Trail Review of laboratory computerised systems
- To understand how to manage the review by exception
- To explain who should perform the Second Person Review
- To present and discuss examples of Audit Trail entries for attendees to identify potential Data Integrity issues
Hintergrund
EU GMP Annex 11 on computerised systems has required a “regular review” of Audit Trail Entries since its publication in 2011. In addition, the Data Integrity guidance documents issued by MHRA, WHO, FDA, EMA and PIC/S over the past few years reiterate the need for review of Audit Trail Entries as part of a Second Person Review of analytical data. However, like all regulations and guidance these documents emphasise the “what” that must be done but leave the “how” to each laboratory to interpret and then implement. For example:
- Do I need an Audit Trail function for all computerised systems?
- What is meant by a regular review of Audit Trail Entries?
- In some organisations, there is confusion about who should review Audit Trail Entries - is this a laboratory or quality assurance role?
- What does a risk-based or review by exception of Audit Trail Entries really mean and do all laboratory informatics applications offer this approach?
This is also compounded by the fact that most laboratory software applications were initially designed before Data Integrity issues took centre stage in the eyes of the regulators. How can GMP regulated organisations influence software suppliers?
This Live Online Training is designed to help GMP organisations understand what is included in a review of Audit Trail entries and how to conduct a risk-based review.
This Live Online Training is designed to help GMP organisations understand what is included in a review of Audit Trail entries and how to conduct a risk-based review.
Zielgruppe
- Managers and staff from Quality Control and Analytical Development Laboratories of pharmaceutical companies
- Contract Research Organisation and Contract Manufacturing Organisation laboratory personnel
- Quality Assurance staff involved in reviewing laboratory data or performing Data Integrity audits
- Auditors (internal and external) responsible for performing self-inspections or external Audits
All participants get free access to the current version of the ECA „GMP, GCP and GDP Data Governance and Data Integrity“ Guidance.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Introduction to the Course
Regulations and Guidance for Audit Trails and their Review
- An overview of the regulatory framework: EU, FDA, MHRA, WHO and PIC/S regulations
- Data life cycle in analytical laboratories
- Audit Trails in GMP inspections: What are the expectations of the inspector?
Audit Trail Review as part of a Data Integrity Strategy
- Define ATR as element of the DI strategy
- Risk-based approach – how to apply
- Apply a systematic approach to define ATR
- Audit Trail Review concepts
Validation of Audit Trail Functionality
- Specification of Audit Trail requirements in the URS: dos and don’ts
- Documentation of the application configuration for Audit Trail functionality
- Leveraging the supplier’s development and testing into your validation effort
- User acceptance testing of Audit Trail functionality
Case Study 1:
Validation of Audit Trail Functionality
Validation of Audit Trail Functionality
- The attendees will review user requirements for Audit Trail functions to highlight good and bad practices and from good requirements design Tests to verify correct functionality
- Documenting the assumptions, exclusions and limitations of your chosen test approach
Audit Trail Review in Context of Second Person Review
- Overview of the analytical process from sample to reportable result
- Highlight the use of computerised systems and Audit Trails
- Use technical controls to focus review effort
- Audit Trail Review issues for manually entered data into a laboratory system and electronic transfer between systems
When is an Audit Trail not an Audit Trail?
- What do we look for in an application for auditing?
- Which Audit Trail(s) should I review?
- Event logs vs. audit logs
Where do Suppliers help us and where do they let us down?
- What do we expect from the suppliers to support data and Audit Trail Review?
- Identify and avoid typical pitfalls
- Data ownership
- Data packaging and storage – supplier vs. business
Case Study2:
Which Audit Trail to review?
Which Audit Trail to review?
- Attendees will be presented with an overview of the Audit Trails within a chromatography data system and the content of each one
- Which Audit Trails should be reviewed and when?
What are GMP-relevant Data?
- Annex 11 requires that audit trails monitor GMP-relevant data – what are GMP-relevant data?
- What are critical data and how can they be determined?
- Direct/indirect, static/dynamic data
- Data, Audit Trail and criticality?
Case Study 3:
Identifying GMP-relevant Data
Identifying GMP-relevant Data
Developing a matrix for risk-based Audit Trail Reviews. The participants will apply the principles to a list of laboratory records to identify, if they are GMP records to help focus the Second Person review of Audit Trail data.
Review of Audit Trail Entries
- Guidance for “regular review” of Audit Trails
- Process versus system: avoiding missing Data Integrity issues when only focussing on a per system review
- What are we looking for in an Audit Trail Review?
- Suspected Data Integrity violation - What do we need to do?
Case Study 4:
Reviewing Audit Trail Entries Part 1
Reviewing Audit Trail Entries Part 1
- Attendees will be provided with a series of Audit Trail entries at the system level to review. Are there any potential Data Integrity issues to be followed-up?
Controls to aid Second Person Review of Audit Trails
- 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?
Case Study 5:
Reviewing Audit Trail Entries Part 2
Reviewing Audit Trail Entries Part 2
- Attendees will be provided with a series of Audit Trail entries at the data capture and interpretation level to review. Are there any potential Data Integrity issues to be followed-up?
Key Learning Points and Q&A Session
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager"
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E-Mail: info@concept-heidelberg.de
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