Any computer systems responsible for creating, modifying, maintaining electronic records, and managing electronic signatures must meet validation requirements (21 CFR Part 11). These systems must be validated to ensure accuracy, reliability, consistent performance, and the ability to detect invalid or altered records.
Aligned with FDA software validation guidelines, we offer comprehensive support in validating the Cloudbyz eClinical platform. Our commitment extends throughout the validation process for the entire solution:
Ensuring proper installation of the solution.
Providing documented evidence that operating characteristics meet defined system limits and specifications.
Transitioning from OQ to PQ to establish documented evidence of consistent system performance.
Offering design and test traceability to meet regulatory requirements.
ISO 9001:2015 and ISO 27001:2013 Certified
