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Spectrum Stability
Stability testing in the Pharmaceutical, Food and other industries entails product behavior monitoring during its complete life cycle spread over many years. The monitoring is performed across different months, storage conditions, packaging and orientations. Information and trends on the stability life cycle data is of immense importance for product evaluation and regulatory compliance.
SPECTRUM Stability is an FDA 21 CFR Part 11 compliant software, that includes functions and features to control the complete life cycle study of a batch/sample in a simple and logical fashion.
The benefits of Spectrum Stability include, but are not limited to, degradation monitoring, time saving and historical data maintenance, rework reduction, efficient time management and the comprehensive reporting of stability data.
Spectrum Stability handles stability studies of a sample on different packaging, conditions, orientations and testing intervals. Spectrum Stability is capable of handling accelerated stability studies, in addition to routine studies.
Testing protocols (Tests & Limits) for the stability study of a group of samples can be defined into Spectrum Stability – every individual sample maintained for stability study will follow the rules defined for its particular group.
Multiple methods to conduct a test can be established in Spectrum Stability, allowing the user to perform every test as per its requirements, keeping the results together under the particular test.
In addition to the passing limit, Spectrum Stability supports action/target and other limits to facilitate the gathering and managing of test results, and behaviour monitoring.
Simple and complex result calculating formulae can be defined into Spectrum Stability, providing the user with a simple process for calculating final results from the raw data. In addition to the final result, Spectrum Stability keeps the source raw data to facilitate further analysis and decision making. Spectrum Stability also manages repeat test results on individual samples.
Work list assignment in Spectrum Stability helps in the time and resource management of a lab by distributing testing work load to different analysts on an individual test level, at the time of the study initiation at a particular interval.
Raw data and test results can be transferred directly through “instruments interfacing” or entered manually into Spectrum. Spectrum Stability provides a fast and convenient approach to enter results in manually.
A decision by an authorized user is required to complete and close the testing for each study interval. Spectrum Stability provides the complete details of the study to the decision-maker within the solution, at the point of decision.
Investigation details and any other information can be maintained in Spectrum Stability for each study for knowledge management and audit purposes.
Spectrum Stability provides a wide variety of data outputs, ranging from simple listings, to stability schedules, to analytical reports and decision making reports. It also generates historical data to monitor trend analysis, sample behaviours, analyst performance, result comparison and compilation of periodic reviews.
Shelf life forecasting based on completed intervals’ results is a strong feature of Spectrum Stability, predicting product behaviour in future months based on the study conducted in previous months.
Spectrum Stability has a comprehensive reporting and analysis tool set to provide different views of the data through graphical presentations, trend analysis and real-time reporting.
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