ALCOA+ commitments
- Attributable. Every record is traceable to the analyst, instrument, and time of acquisition through controlled user accounts.
- Legible. All records are recorded in human- and machine-readable form. Manual records use indelible ink and controlled corrections.
- Contemporaneous. Records are captured at the moment of activity. Backdating is prohibited and detected through audit trail review.
- Original. Source records (chromatograms, raw spectra, balance prints) are retained as primary data.
- Accurate. Calibration, qualification, and method validation establish accuracy. Independent QA review precedes every report release.
- Complete, Consistent, Enduring, Available. Records, including all changes, repeats, and metadata, are retained for the regulated lifetime and remain retrievable on demand.
System controls
Chromatography data systems (Waters Empower, Thermo Chromeleon, Sciex Analyst) and our LIMS are configured with unique user IDs, role-based access, password complexity, automatic logoff, time-stamped audit trails, and periodic audit-trail review by QA.
Audit trail review
Audit trails are reviewed as part of every analytical batch release. Anomalies are documented and investigated per our deviation SOP.