ON-DEMAND WEBINAR: Balancing Technical Controls, Tools, Transparency, and Trust for a Culture of Data Integrity

Library Number:
WEBC134950712
Author(s):
Heather Longden
Content Type:
On Demand Webinar
Content Subtype:
Compliance and Regulatory

ON-DEMAND WEBINAR:

REGISTER NOW!

All attendees will receive a free executive summary of the webinar


Event Overview

“Testing into Compliance” or “Testing into Specification” is a critical quality issue that regulators have found occurs in some laboratories. Repeating testing without a formal investigation is viewed with suspicion by regulators. Non-reported information may contain data suggesting that samples are not meeting specifications. But very often so-called “orphan data” is simply a relic of trained, expert and ethical analysts striving for the most accurate result. In this webcast, we will discuss key concerns related to data integrity as well as strategies and steps that companies can take to create or maintain a culture of data integrity. Topics discussed will include:

  • Regulated companies are right to review the privileges and freedoms that their analysts have when using computerized systems
  • In order to physically “prevent” potential data manipulation, technical controls should be implemented when available and practical
  • However, the over-tightening of access to useful data processing tools, because they “might” be used to manipulate results, often severely prevents the analysts from doing their jobs
  • In today’s laboratories, it is a challenge to finding the right balance between restricting access to functionality and ensuring scientific and thorough review and oversight of how those tools are used


Key Learning Objectives

  • Comprehend the exact concerns of Quality groups and regulators about the quality and trustworthiness of “complete data” and orphan data
  • Evaluate the value of computer system technical controls, including what undesirable behavior they prevent and what critical workflow activity they enable
  • Review the procedural processes you have in place to answer important questions. What is the efficiency impact of strict analytical data creation rules? Are they driving unintended behavior in order to complete the laboratory work expectations?
  • How to build an oversight process that permits the correct use of software tools, and yet eliminates misuse of those same tools to hide undesirable results
  • How to building a culture of scientific objectivity and trust in your analytical staff


Who Should Attend

  • Regulated companies (pharmaceutical, food, environmental)
  • Laboratory directors, managers, and analysts
  • Information technology professionals supporting laboratory applications: managers, business system analysts
  • Quality assurance professionals


Presenters

   

Heather Longden
Senior Marketing Manager
Informatics and Regulatory Compliance          
Waters Corporation

Laura Bush, Moderator 
Editorial Director
LCGC