Electronic Label Tracking and Approval

The Electronic Label Tracking and Approval application records content changes of package labels throughout the manufacturing process. Labels are routed through the organization electronically for revision and approval. Label Tracker provides a secure, web-based environment with various levels of authentication for reading, editing and approving documents.

Electronic Label Tracking and Approval System Features:

• System Security limits access to team members and responsible parties, protecting confidential information.
  
• Version Control records and tracks all changes to each Label.
  
• Audit Log tracks who performs each change or approval step, complying with FDA CFR 21 Part 11 requirements.
  
• Life Cycle Tab allows instant access to each users' projects and status, streamlining workflow and prioritization
  
• Integrates fully with your existing corporate e-mail system, making notification and communication easy.

The Label Tracker system records every edit and revision of a label, as well as providing a record of those individuals who authorize change or make approvals. In addition, the system maintains a historical record of prior labels, wording, and approved claims that can be used to efficiently create new material based on past successes.

The organization of the document routing helps prevent last minute changes by a department late in the review chain that are never seen or approved by those departments that have contributed early in the review cycle. Mistakes such as these can cost millions of dollars in wasted product and production time, or even result in fines and legal fees if they are not caught before the product is released to market.

By working in a secure environment and creating a record of each change to the labels, the Electronic Label Tracking and Approval System removes the possibility of last minute changes that are not properly reviewed and approved. The system also maintains a copy of each version of the label, so that the change process can be clearly tracked and steps can be undone quickly and easily. Since the approval process is tracked from beginning to end, each department and responsible party is aware of the progress of each project, thereby quickly identifying and eliminating potential bottlenecks. Finally, since the system is electronic, there is no possibility of label copies being accidentally lost, damaged, or destroyed, which would otherwise result in a costly delay while the entire process is restarted.

The Electronic Label Tracking program is extremely easy to use. A web-based interface provides not only compatibility with your existing corporate infrastructure, but is familiar to your users, reducing training requirements. The Life Cycle Tab shows each user the status of their projects and acts as a dynamic "To Do" list showing outstanding items and responsibilities. This gives each user a place to look to review all their projects and tasks, and allows team leaders and managers to see the status of any item at a glance.

Label Tracker has been developed in compliance with the FDA's Code of Federal Regulations for audit trails and version control. The system's efficient workflow can easily be integrated into existing corporate networks and e-mail.

As an additional option, the Electronic Label Tracking and Approval system can be integrated with other Prelude products to allow label changes to be submitted to the FDA electronically.

Prelude Computer Solutions, Inc., 26 Hill Road, Parsippany, NJ 07054. Tel: 973-331-3740; Fax: 973-331-3741.