There is often a lack of clarity concerning what qualifications and specifications a software solution requires to comply with 21 CFR Part 11. Compounding the ambiguity, many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the regulation. Even when a solution meets all of its requirements, ensuring that procedural requirements are met is typically the bigger challenge.

The true essence of the regulation can be simplified into three main categories.

• Process  – Clear documentation of the software solution’s build process
• Validation  – Clear documentation of the software solution’s validation process along with evidence of validation
• Training  – Clear documentation of the software solution’s training procedures along with evidence of user training

The intent of this paper is to describe how Itrica products provide a built-in platform for 21 CFR Part 11 compliance that allows sponsors to validate, monitor and control their processes.

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