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Operation of the Liberty Blue
Data Integrity
The Liberty Blue provides a software solution for automated microwave peptide synthesis users to aid in achieving
compliance with the FDA’s guidance on electronic records and electronic signatures: 21 CFR Part 11.
1. Software allows viewing of records for validity. Records include a date of last modication and a revision number
which is incremented upon modication.
2. Software has the ability to authenticate individuals via local accounts within the application software. User
accounts can be created, disabled and re-enabled by the administrator.
3. Software authenticates users based on both a unique user name and password security. Each user is a member
of a particular user group. Each user group species a list of privileges allowed and disallowed to users of that
group.
4. Software stores records in encrypted databases to ensure easy retrieval and prevents records being read or
altered outside of the application.
5. Software requires user to sign records and reports as well as changes in methods with a unique user name
and password. User name, the date and time the signature was executed, and the meaning of the signing are
recorded.
6. Software records the signature(s) in the record audit trail which may also be viewed and printed.
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