Lonza Workshop & Live Session 

Practical applications of Data Integrity and Audit Trail Review

R Lutskus Paperless Lab Academy

Presenter: Robert Lutskus,  Associate Director Commercial Operations at Lonza

Rob was a Quality Control microbiologist for 10 years in pharma before transitioning to the laboratory informatics space. He has run and supported implementations and validations of software at numerous organizations globally and now heads the delivery team for the MODA EM solution.

 

 

 

Overview

The why, what, when, where, who and how of audit trail review

Session learnings

Learnings from this workshop will be:

- Regulatory requirements around audit trail review
- Examples of audit trail review strategies
- Roles for audit trail review

Lonza QC micro

Who should benefit 

Anyone involved in selecting, implementing or maintaining electronic systems. 

Areas covered 

- Why – The focus on audit trails
- What – The basics of an audit trail
- When – Frequency of review
- Where – Areas of focus in the review
- Who – Responsibility for review
- How – Steps to ensure proper review

 

LONZA EBR

LONZA PAPERLESS LAB ACADEMYMODATM is a comprehensive platform for environmental, utility and product monitoring, combining automated scheduling, workflows, mobile data acquisition, device integration, and visual analytics. It eliminates paper-based monitoring and testing that can be expensive, error-prone, time and labor- intensive, therefore enhancing Data Integrity, reducing timelines and potentially saving clients QC costs. www.lonza.com/moda