COUNTWIRE™ - 21 CFR PART 11 COMPLIANCE

The CountWire™ System allows multiple users to remotely access and manage data from LUNA-FX7™ units, and it completely supports 21 CFR Part 11 compliance, enabling the LUNA-FX7™ Automated Cell Counter to be used in a regulated process.

User Access Control

The CountWire™ System establishes different roles and levels of access and privilege and only authorized ones may access the system with a user ID and password. Upon successful login, they can perform only functions assigned or privileged to the role/level.

 Electronic Signature

All reports may be digitally signed and the electronic signature information includes the name and user ID of the signer, as well as the date, time and meaning of the signature.

 Audit Trail

All actions are recorded within the audit trail, time-stamped, tagged to the user, identified with the instrument name and serial number.

 Data Safety and Security

The CountWire™ System reliably protects all from deletion, overwriting, alteration, and/or possible accidences.