Skyland PIMS And Regulatory Compliance - Approach For US FDA 21 CFR Part 11 Electronic Records And Electronic Signatures

Skyland PIMS is designed, developed, and tested to enable compliance with 21 CFR Part 11 to accommodate the regulatory needs of its users.

Skyland PIMS is a cloud-based, single-tenant SaaS application and available only through an internet connection. The customer is in full control of system access and system content without even IDBS having access to the application. Therefore, it is technically classified as a closed system. Learn more about what Skyland PIMS offers to meet regulations.