21 CFR Part 11 compliance is obligatory for all healthcare industries that manufacture or export their products in or to the U.S. market.
Part 11 is designed to help FDA-regulated companies benefit from the use of electronic data management. In short, it gives detailed guidelines on how to manage electronic records and electronic signatures in order to maintain accuracy and security.
The key objectives of Part 11 regulations include:
- ensuring the generation of trustworthy and reliable electronic records; and
- the ability to detect and keep track of any alterations to electronic records.
The STARe Software Solution
GMP and 21 CFR Part 11 compliance means providing additional security to the data management system.
The STARe software is designed as a closed system, more precisely an environment in which system access is controlled by persons who are responsible for the content of electronic records present on the system.
In order to achieve this compliance, the STARe software provides password access-control to the application, assigns user-rights for each user-level, ensures file integrity with electronic records, and properly logs the audit trail and electronic signatures.