How a complete set of software and validation tools for microplate readers can help GMP/GLP labs meet FDA data integrity guidelines

Sponsored by: Molecular Devices

Speakers

Thomas Hengstl, PhD

Software Product Manager, Molecular Devices
BIOGRAPHY
Sally Higham

Account Manager, Molecular Devices.

Event Date & Time

DATE: May 15, 2019
TIME: 7:00AM PDT, 10:00AM EDT, 3:00PM BST, 4:00PM CET

Abstract

Laboratories operating under GMP or GLP regulations must follow guidelines set by agencies to protect scientific integrity or demonstrate quality assurance of manufactured products. Regulated labs using microplate readers in their workflows need to verify that they are functioning within manufacturing specifications and that the data acquisition and analysis software complies with regulations for electronic record keeping.

SoftMax Pro 7.1 GxP Software is Molecular Devices and its customers’ reply to the new FDA guidelines about data integrity which were released in April 2016. To appropriately address the new data integrity requirements, the software transitioned from storing documents in a regular Windows-based file system to storing files in a Microsoft SQL database. This establishes a complete system audit trail which records all document modifications or movements as well as any changes in data within the documents.

Learning objectives:

How to overcome potential data integrity problems of Windows-based file systems
How to achieve compliance in a single secure system
How to go paperless easily

LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.