Clarity 21 CFR Part 11 compliance

21 CFR Part 11 tools Clarity, Clarity EA and Clarity Offline softwares provide variety of tools supporting the GxP practices. These tools enable to configure the chromatography station in a way to comply with the requirements of the 21 CFR Part 11 directive of the FDA. This ensures its suitability for use in regulated environments.

See the Clarity in Regulated Enviroment guide.

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

Supporting tools for 21 CFR Part 11 requirements

1. Software Validation

Certificate of Software Validation is available upon request.

2. Installation Qualification

The Test IQ (Installation Qualification) is an integral component of the station. This test monitors that the software has been properly installed and the results can be accessed from a printed protocol.

3. Operational Qualification

Validator for OQ (Operational Qualification) is an optional package available for testing and validating the station. This is accomplished simply with the use of our chromatogram generator and a software utility.

4. Logon with Password

5. User Accounts

Selectable rights, unique user profiles This system allows to create a unique password protected profile for each user. The user profile then defines in detail the user's rights within the station (e.g. authority to effect changes in the methods of measurement) and may limit ones access to only certain connected instruments.

6. Password expiration and minimal length

7. Electronic Signatures

Electronic signature implemented. A user may sign his or her data. This electronic signature is stored with the name and date and supplemented with a set phrase (e.g. measured by, approved by, etc.). Two types of electronic signatures have been implemented: a) using user accounts b) using a certificate. The signature information associated with the signing that indicates the printed name of the signer, the date/time, and the meaning, is included in any readable form of the records (see paragraph 11).

Certificates used for electronic signatures are not part of Clarity installation and such certificates are to be provided by certification authorities. DataApex does not issue any certificates for electronic signatures.

8. Audit Trail

Audit Trail of whole system, chromatograms, calibrations and sequence. Audit Trails are part of corresponding files. Detailed logs and histories of modifications enable users to maintain an audit trail. The station documents all parameters describing the conditions and methods of data processing for the user. This allows for easy access to a complete profile of information regarding any prior modification's performance.

9. Record of all changes

History of all methods and calibrations as part chromatogram files.

10. System Suitability Test

Method performance and system consistency monitoring.

11. Printed reports

Page numbering, labeled with date and time of analysis and print out, includes information about applied electronical signatures. Reports can be printed to electronically signed PDF files.

21 CFR compatible SW

21 CFR related tools

Linkedin Facebook Twitter Youtube  DataApex Clarity
HTML navigation
Last updated: 2020-06-06 | webmaster