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Audit Trail Review - Workshop
From regulations to practice
GMP Regulations require that the creation, change or deletion of GMP data (in paper or in an electronic format) need to be traceable throughout its life cycle. Annex 11, "Computerized Systems", of the EU GMP Guideline specifies, in chapter 9, the following requirement: “Consideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated “audit trail”). For change or deletion of GMP-relevant data the reason should be documented. Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed”. Audit trails are metadata that allow us to reconstruct the history of a piece of data from its creation until its deletion, identifying "Who, What, When and Why" (ref. Draft Guidance "Data Integrity Guidance for Industry", April 2016) for every step of its life cycle. The regulations require that the audit trails are periodically reviewed in order to check the integrity of data, and to identify and investigate any inappropriate changes to GMP data. This Workshop aims to help participants in carrying out an audit trail review by discussing case studies during the session.
A. Audit and Audit Trail Review: what do regulations ask for?
1. Definitions and regulatory requirements
- FDA 21 CFR part 11, Eudralex annex11/chapter 4
2. What do guidelines say?
Each session will be backed with practical examples
B. Audit Trail Review: where do I start?
- Business Process vs Data
- How to identify the critical (GMP relevant) data of a system?
C. Identify the different types of audit trail in a system
- Audit trail
- Log file
- Legacy system without electronic audit trail: how to do it?
D. Determine the frequency with which an audit trail review is needed
- What are the elements that define the frequency with which an audit trail review is needed
E. Who are the actors of the process of an Audit Trail Review and what are their responsibilities
- Business process Owner
- Quality Assurance
- System Owner (e.g. IT, Engineering)
F. How to do an audit trail review
- Which elements you need to consider during the review?
- How to document the outcome of the review?
Stefano Piccoli is a biomedical engineer. He founded QStep srl, a services company specialized in Computer System Validation, IT compliance and Data Integrity in the context of GxP. He has more than 20 years experience in the pharmaceutical field (GxP). In particular, in the following areas: Computer System Validation, IT/QA Risk Management, and Quality Assurance. In recent years, he has devoted himself to further study and analysis different aspects of Data Integrity and Information Security. He was granted an Executive Master degree in IT Governance & Management by the LUISS Business School in 2015. He is PMP, ITIL V.3 Transition, CobIT 5, CISM certified. He collaborates with some of the most relevant Italian pharmaceutical companies as consultant for Data Integrity.
The course is designed for all professionals working in the GMP field within life sciences, with particular interest for those involved in the audit trail review (e.g. labs, production, quality assurance).
Interactive training with practical examples
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 880,00* (until 6 October 2020)
Ordinary: € 990,00*
Freelance - Academy - Public Administration: € 490,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Tuesday, October 6, 2020
At the end of the training, you will be able to
Identify which are the GMP date for which an audit trail is needed
Know the steps in an audit trail review process
Know how to document an audit trail review