The Cerulean 21CFR PART 11 software upgrade for SM450e is applicable to customers who wish to comply with the 21CFR PART 11 directive - Title 21 of the Federal Regulations.
This directive regulates food and drugs within the United States for the Food and Drug Administration and other agencies.
Software upgrades pay special attention to electronic records and signatures, and provide the following features and benefits:
Audit trail: Computer hardware and software that comply with the following regulatory requirements: www.fda.gov/media/75414/download
Electronic signature: Password protected access for all user groups: Supervisor, Operator, Owner IT, Service
Version control: Secure operation records, such as new creation, modification, maintenance, archiving, retrieval, or transmission.
User authentication: Anyone performing an operation will be recorded for complete traceability of who did what and when.
Login control: In the future, it will be impossible to manipulate or tamper with security records.
Data Security: This software package ensures:
A functional and well recorded instrument
Verify functions related to data integrity, security, and traceability
