FDA VALIDATION

Our software supports the requirements designated by FDA Code of Regulations Title 21 Part 11. The U.S. Food and Drug Administration (FDA) has implemented Process validation as a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21 CFR 211) and GMP regulations for medical devices (21 CFR 820). Process validation involves the collecting, storing and evaluation of the secured data taking place over the lifecycle of the product and its process.

Prospective validation is characterized as establishing documented evidence showing a system and or process does what it is proposed to do based on preplanned protocols. This approach is normally undertaken whenever the process for a new formula (or within a new facility) must be validated before routine pharmaceutical production commences. The protocol is developed by the owner’s validation team in conjunction with Delta Connects during the design stage and implemented prior to commencing actual production. As a requirement of Process validation continuing certification is required at a predefined interval which is designated as Revalidation. Revalidation means repeating the original validation effort or any part of it on a mandated time schedule. This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. The Delta EnteliWEB software supports the requirements designated by FDA Code of Regulations Title 21 Part 11 by

Providing multiple techniques to store the lifecycle data

• Allowing for the development and exporting of custom reports and user logs to non- modifiable formats such as PDF
• Requiring secure enteliWEB username and passwords for authorized individuals which can be combined with LDAP security protocols
• Enforcing unique electronic signatures on modifications made in validated environments and recording them in the enteliWEB audit log which includes User, Time/Date Stamp, Value Before, Value After, and Comment/reason for change
• Complete out-of-the-box audit trail for modifications and alarm acknowledgements