Clarity provides a number of tools to support GxP workflows.
These tools enable Clarity to be configured in a manner that meets the requirements of 21 CFR Part 11, ensuring its suitability for use in regulated environments.
Declaration of Software Validation
The installation qualification (IQ) is an integral component of the station. IQ tests whether Clarity has been properly installed. IQ results can be printed as protocol.
Operational Qualification (OQ) is an integral part of Clarity for testing and validating Clarity. OQ is automated routine providing three reports with results and requires System Suitability extension for its operation.
Clarity provides configurable permissions for individual user accounts. Allows you to set up a password-protected Clarity user to suit his or her role. The user account defines in detail the privileges of an individual within Clarity, such as the right to modify measurement methods, access only to certain connected devices and much more.
Clarity allows login into to its environment only after inserting correct login credentials.
Password expiration and minimal length
Clarity allows to establish password policy.
Electronic Signatures - Signing of chromatograms
Clarity allows adding signatures to chromatograms with optional stating of purpose of signature. Chromatogram stores entire signature history and These signatures can be done using Clarity User Accounts or using 3rd party issued certificates.
Clarity have implemented a few Audit Trails which track actions performed in its environment under individual user accounts. There is a Station audit trail for entire station and than audit trails of respective data files:
• Chromatogram audit trail
• Method audit trail
• Calibration audit trail
• Sequence audit trail
Audit trails of respective data files are inseparable part of the data files and track actions relevant to respective data file.
The chromatogram and method have internal file versions implemented. Each time you save a file, a new version of that file is created. From the file history it is possible to open and check all older ones at any time.