Enforcing Permitted Sequences

Ideally, a 21 CFR Part 11 compliant application should be usable for quality assurance in a manufacturing process. To meet this goal, it is necessary that the application support "operational system checks to enforce permitted sequencing of steps and events". In other words, it should be possible for a technician in quality assurance to run the application with minimal input and limited possibility to affect the results through incorrect decisions.

ASTRA has strong support for enforcing permitted sequences through the template mechanism. A user with Researcher privilege level can create a new method, and then save it as a template. A user with Technician privilege level can only use the template to collect and analyze data, and cannot make changes to the template configuration, analysis, or results reporting.

With its advanced template technology, ASTRA stands ready to move macromolecular characterization into everyday manufacturing and quality assurance applications.

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