Clarity 21 CFR Part 11 compliance

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.

Refer to Clarity in Regulated Environment guide for detailed information.


Supporting tools for 21 CFR Part 11 requirements

Declaration of Software Validation
Certificate of the software development, testing and structural validation (see the D021 Declaration of Software Validation datasheet).
Installation Qualification
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
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.
User Accounts
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.
Login with Password
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.
Audit Trail
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.
Versioning of the files
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.


Do you own Clarity Lite? Upgrade to Clarity on favorable terms which enables your Chromatography Software to comply with 21 CFR Part 11 legislation.