21 CFR Part 11 insight: Solutions to keep your thermal analysis work in line with FDA requirements


CFR21 compliance of the STARe Software 

The FDA 21 CFR 11 regulations specify three types of controls.  Procedural and administrative controls are the responsibility in contrast to technical controls that are the responsibility of the software supplier.

The CFR STARe software option allows the user to work with a compliant system under FDA regulations. The purpose of FDA regulations is to ensure the integrity, trustworthiness and reliability of electronic records throughout the data life cycle.

METTLER TOLEDO’s STARe software complies with the technical challenges presented by the FDA regulations, such as data acquisition, managing the record, data backup, audit trails, security and access control.

In this webinar, METTLER TOLEDO will introduce the requirements assigned by FDA related to electronic data management system and their solutions to keep your thermal analysis work with ease and satisfactorily in a regulatory environment.


Nicolas Fedelich
Senior Applications Specialists
Thermal Analysis

NicolasFedelich is an application specialist for thermal analysis at Mettler Toledo.With a background of chemical engineering in France, he worked in differentlaboratories to implement, develop and validate analytical methods in thepharmaceutical and environmental fields. Before joining Mettler-Toledo, NicolasFedelich worked for three years as field support for on-site training and toensure customers satisfaction by advising them on their applications.
In 2009 he joined Mettler-Toledo AG and has worked there since as applicationspecialist for Thermal Analysis. In his present position he uses, teaches andsupports DSC, TGA, TMA and DMA instruments.

Bob McDowall
R D McDowall Ltd

BobMcDowall is an independent consultant in pharmaceutical regulations, computervalidation and data integrity who has published and taught extensively in theseareas.  He also advises on the regulatorycompliance of software applications.

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