 |
This white paper details the regulatory requirements for computerized systems – such as thermal analyzers – and important steps to avoid costly data integrity violations. |
“Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.”
From MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March 2018
Data integrity is a central issue in all laboratories which are regulated by Good Manufacturing Practice (GMP). However, even research laboratories and industries which are not regulated can recognize that the benefits of establishing good data management practices outweigh the costs. The regulatory background will be discussed in this White Paper followed by system architecture, which is important in computerized systems such as thermal analyzers.
For all systems which store, process, and retrieve data – such as thermal analyzers – data integrity is paramount. STARe thermal analysis software provides password access-control to the application, assigns user-rights for each user-level, ensures file integrity with electronic records stored in a secure database, and properly logs the audit trail and electronic signatures. STARe software also permits electronic transfer of balance data (STAReX™ connectivity) and automated backups for enhanced data security and efficiency.
Data integrity controls in STARe are available in two options to suit the needs of regulated and non-regulated industries alike:
 |
Links to Key Resources Can Be Found Below
STARe Data Integrity Software Option
The STARe User Rights software option described in this datasheet allows different users to be assigned specific roles and access rights.
 |
Thermal Analysis Data Integrity Assessment
Performing a quick assessment to identify and mitigate potential data Integrity issues stemming from your thermal analysis system.
Validation Handbook
The "Validation in Thermal Analysis" handbook is intended for beginners and specialists interested in the theoretical, practical and regulatory aspects of validation, covering equipment qualification (EQ), software validation and method validation aspects.
21 CFR Part 11 Compliance
Everything you need to know about the STARe CFR option can be found in our 21 CFR Part 11 datasheet.
Thermal Analysis UserComs
Thermal Analysis UserComs are a valuable resource for users wanting to improve the quality and reliability of their results.
GTAP
Good Thermal Analysis Practice, abbreviated to GTAP, covers the entire lifecycle of your thermal analysis system – from initial evaluation and selection, to installation, training and routine operation.
CFR Webinar
In this webinar, METTLER TOLEDO introduces the scope and requirements for 21 CFR Part 11 compliance and the METTLER TOLEDO STARe software solutions supporting them.
TA Services
Benefit from METTLER TOLEDO's world-class services, be it hands on trainings and interactive webinars or educational materials such as handbooks, UserComs and TA applications written by thermal analysis experts. Discover more here.
TA Service & Support
We support and service your measurement equipment through its entire lifecycle – from installation to preventive maintenance and calibration, to equipment repair.
Benefit from our TA service offering
