Laboratory Information Management System (LIMS) Validation Checklist

Validation Planning and Requirements

Establish the validation approach.

• Is a validation plan in place based on a risk assessment and GAMP software category? *
• Are user requirements and functional specifications documented and traceable to testing? *
• Is the supplier assessed or audited to leverage their development lifecycle?

Configuration and Interfaces

• Are specification limits, calculations, and workflows configured and verified against approved methods? *
• Are instrument and enterprise interfaces (e.g., CDS, ERP) validated for accurate data transfer? *
• Are automated calculations independently verified? *

Security and Data Integrity

• Are user access, role-based permissions, and segregation of duties configured and controlled? *
• Are audit trails enabled, secure, and reviewed for data-critical changes? *
• Are electronic signatures implemented and linked to their records where used? *
• Are backup, restore, archival, and disaster recovery procedures tested? *

Testing, Release, and Maintenance

• Is installation, operational, and performance qualification (IQ/OQ/PQ) documented and approved? *
• Is a validation summary report approved before release for GMP use? *
• Is the LIMS maintained in a validated state through periodic review and change control? *