Description
Engineered for secure and compliant digital PCR workflows, the naica ® System Pro Software offers a closed-system version of Crystal Reader Software and Crystal Miner Software, with controlled user access and electronic record management. The software supports compliance with U.S. FDA 21 CFR Part 11 when operating the naica System for Crystal Digital PCR™ experiments.
Features and Benefits
• Mandatory password-protected login: Supports controlled access with user roles and permissions management
• Time- and date-stamped audit trails: Provides tracked and saved edit information, with an option to export as a PDF report
• Sample validation: Supports workflow accuracy and compliance
• Electronic signatures: Enables secure approval and documentation
Product Contents
The naica System Pro Software includes the following products:
• naica Data Service: Functions as the naica System user account manager and controls compliance of all naica System operations with respect to 21 CFR Part 11
• naica Reader Pro Software: Provides the operating interface used to define experimental settings for image acquisition on the Prism3/Prism6 scanner within the Crystal Digital PCR workflow
• naica Analysis Pro Software: Serves as the data analysis application for the naica System, enabling image-based data interpretation from images acquired from using naica Reader Pro Software and calculation of absolute nucleic acid concentrations
