Our Gene Therapy software serves several important use cases throughout the process of developing, manufacturing, and storing gene-based treatments, such as:
Manufacturing and Process Control: Controls and monitors critical parameters during vector production and gene modification steps. It also helps ensure consistency, quality control, and regulatory compliance in the manufacturing process.
Supply Chain Management: Offers solutions for inventory optimization, traceability, regulatory compliance, environmental monitoring, vendor management, demand forecasting, and waste reduction.
Regulatory Compliance: Tracks and documents regulatory processes, adverse event reporting, ensures data integrity and helps streamline regulatory submissions and manages regulatory documentation.
Quality management: Involves processes like Software Validation and Verification (ensuring alignment with design and meeting user needs), Regulatory Compliance (adhering to guidelines and documenting processes), and User Training and Support (ensuring proficiency, safety, and proper utilization).
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