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Relief without Side Effects – Being 21 CFR Part 11 Compliant with Qtegra Intelligent Scientific Data Solution Software

Team TFS
Team TFS
softwareWe all appreciate modern, over-the-counter medicines – especially at this time of the year when, just after getting out of the flu and cold season, we are thrown directly into allergy season. There may have been occasions over the last couple of months when you were seeking relief for dizziness during a cold, or you will be looking forward to reducing those itchy red eyes and dripping nose caused by blooming bushes and flowers.

However, pharmaceutical products can also have potential side effects which are commonly ignored, as most of us don’t notice them. Nevertheless, they do exist and we need means to control them effectively.

After the latest revision of the United States Pharmacopeia (USP) chapters <232> and <233> became official on January 1, 2018, many analytical chemists fell victim to another side effect of the cure - the need to perform analysis of trace elements in full compliance with regulatory guidelines such as Part 11 of Title 21 of the code of Federal Regulations (or often referred to as 21 CFR part 11) that deals with electronic records and electronic signatures.

No software can claim to be fully compliant by default, it can only provide the appropriate tools to be compliant in conjunction with established protocols for the users. However, the latest version of the Thermo Scientific™ Qtegra™ Intelligent Scientific Data Solution (ISDS) Software, a software platform for the Thermo Scientific™ iCAP™ 7000 Series ICP-MS and Thermo Scientific™ iCAP Qnova Series ICP-MS, contains a lot of new features that help both analysts and lab managers to achieve compliant analysis of trace elements of the (currently) well-requested anti-histamine drug products (and, of course, all other drug products). Using an instrument-agnostic, plug-in based architecture, Qtegra ISDS Software uses functionality implemented by Microsoft® Windows® to control and restrict access to the software and limit certain actions to manipulate system settings or datasets. The Qtegra ISDS Software data files (the so-called LabBooks) contain a complete record of all relevant information regarding a measurement. This comprises raw data, calculated results, and meta-data, such as instrument read backs or log messages occurring during the run. In short, all information that an analyst would also record in a paper based laboratory notebook to fully describe the experiment.

Qtegra ISDS Software contains a complete user management system that allows a laboratory manager to grant and deny users access to certain functionalities in the software. It also tracks attempts to log onto the computer that runs the instrument. Different Audit Trails ensure that complete “When? Who? Why? and What?” traceability is in place for each LabBook, and they also track all settings in the software (for example, electronic signature workflows). The intelligent, service-based data acquisition allows the analysis to continue over shift changes and is independent of the main graphical user interface. The biggest relief to most, however, is the powerful reporting engine of Qtegra ISDS, which allows the laboratory to demonstrate successful method validation according to chapter <233> directly from the software.

So, be prepared to alleviate the side effects of elemental impurity analysis in drug products and download the Smart Note to learn more about Qtegra ISDS Software and its advantages with respect to 21 CFR part 11 compliance.