Audit Trail Review for Computerised Systems in Analytical Laboratories - Online Training Recording

Costs

*ECA-Member:**	EUR 1590,--
*Regular Fee:**	EUR 1790,--
*EU/GMP Inspectorates:**	EUR 895,--
*APIC Member Discount:**	EUR 1690,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Markus Dathe, F. Hoffmann-La Roche AG, Basel, Switzerland
Dr Bob McDowall, Member of the ECA IT Compliance Interest Group
Dr Frank Sielaff, GMP Inspector, Regional Authority, Darmstadt, Germany

Objectives

The objectives of this ECA Live Online Training are to provide:

An understanding of the regulatory requirements for Audit Trail Review of laboratory computerised systems
Understand how to manage the review by exception
Who should perform the Second Person Review?
Discuss Audit Trail examples for attendees to identify potential Data Integrity issues
Present examples of Audit Trail Entries for attendees to identify potential Data Integrity issues

Background

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.

Target Group

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

Technical Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programme

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

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?

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

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

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?

Case Study 5:
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?

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?

Recording from 3/4 May 2023

Duration of Recording: 10h 50min

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