Meeting 21 CFR 11 Regulatory Requirements

Galaxie's audit trail tools, electronic signature capability, and electronic record generation, help ensure that your records are in compliance with 21 CFR Part 11 requirements.

Audit Trail
A rigorous Audit Trail tool records and archives all operations and file modifications with an automatically incremented version number. Details of various file versions, e.g., chromatograms, methods, sequences, and calibration curves, are viewed on-screen.

Electronic Signature
User profiles defined in the Galaxie's Configuration Manager control the access users have to methods, data, and reports. Security is managed through user ID and password checks.

On any workstation screen, users can review, approve, and validate reports with an electronic signature. Operators and supervisors may sign a single report with various levels of authority.

Electronic Records
Processed chromatograms and corresponding records can be locked within Galaxie when electronically signed by authorized users. Only the same authorized users can unlock these files. When final reports are issued, approved, and electronically signed, Galaxie automatically generates a PDF file which can be read with Adobe™ Acrobat. All signature/locking operations are tracked in the audit trail.