eLabelinfo Enterprise Label Management System Features

Electronic Records and Audit Trail

eLabelinfo maintains an audit trail of all labeling operations such as label scheduling, printing, print failure, resubmission and label reprinting. The audit trail includes the user name and user identifier, date, time, label identifier, the labeling operation that was performed and the Reason field as applicable. Reason fields can be configured as required for specific audit trail events such as label reprinting.

Electronic Signatures 

Create e-signature rules defining the labeling operations that require e-signatures. Different rules can be applied to labels used in different areas such as development, clinical or manufacturing, providing unlimited flexibility and control in configuring e-signatures to meet varying business and compliance requirements. Define meanings (roles) for e-signatures and restrict user authority for e-signatures to specific roles.

Label Reconciliation

Reconcile labels using standard and configurable reports based on the Label History database. Create Label Reconciliation Reports based on configurable criteria such as user names, labels, date interval, and label status.

Label Design File Vault

Label design files are automatically stored in the system's secure File Vault with Version Control, Configurable Version Numbering and Check In/Check Out features.

Security

Create security templates defining access levels for various labeling operations. Different templates can be applied to different labels providing unprecedented flexibility and control in assigning user privileges to label operations.

Select users with privileges to configure and schedule each type of label or to reprint labels.

Change Management

Label Specifications: Automatically maintains label specification versions and ensures that the correct version of the Label Design file is used to print labels. Provides full traceability between printed labels and the file version used to print the label.

Relationships: View the status of all related labels for improved change management.

Maintenance/Change Logs: Create and attach maintenance/change logs to a label.

Collaboration

Securely share the label database repository between QA, QC, manufacturing, laboratory and development environments within a 21 CFR Part 11 compliant data architecture.

Discussion Groups: Discuss issues using threaded discussion groups organized by topic.

Notes: Attach comments to a label using free text. Pass on instructions and relevant information between shifts and operating personnel.

Search

Database Search: Search the Label Database, Change Logs, Notes and Discussions using keywords.

Audit Trail: Query the Audit Trail Database using criteria such as User Name, Date Interval, Label Name, and Action performed.

Full Text Search: Perform a full text search of all files in the File Vault.

Label Interfaces

Design labels using popular third-party Label Design software applications. Integrate with existing systems such as ERP, MES, and LIMS.