ALCOA+ in LIMS

Executive Summary

Regulatory agencies (FDA, EMA, WHO) mandate strict adherence to ALCOA+ principles to ensure data integrity in pharmaceutical and biotech laboratories. This white paper demonstrates how a Laboratory Information Management System (LIMS) serves as a foundational tool for achieving and maintaining compliance by:

• Mapping each ALCOA+ principle to specific LIMS functionalities
• Providing technical safeguards against data manipulation
• Presenting real-world examples where LIMS could have prevented regulatory violations
• Offering a practical implementation framework