IDBS PIMS and regulatory compliance – approach for US FDA 21 CFR Part 11 electronic records and electronic signatures
IDBS PIMS and regulatory compliance – approach for US FDA 21 CFR Part 11 electronic records and electronic signatures
4 PagesThe IDBS PIMS Regulatory Compliance infosheet explains how the cloud-based platform is designed to support compliance with U.S. FDA 21 CFR Part 11 requirements governing electronic records and electronic signatures. Built as a single-tenant SaaS solution, IDBS PIMS gives customers full control over system access and content, enabling it to operate as a closed system under regulatory definitions. The platform includes features that strengthen compliance, data integrity, security, and audit readiness, such as configurable approval and signature requirements, session timeout controls, login restrictions, and electronic signature capabilities. These functions help ensure that electronic records are secure, traceable, and properly managed throughout their lifecycle. By supporting regulatory com
