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
Contact
Phone
+1 (780) 448-9152
Address
18220 – 102 Ave NW, Edmonton, AB T5S 1S7
Phone
+1 (647) 789-2600
Address
100-5525 Eglinton Ave W, Etobicoke, ON M9C 5K5
Phone
+1 (732) 355-7177
Address
10 Centre Drive, Monroe Township, N.J. USA, 08831
Phone
+1 (212) 629-8844
Address
5 Penn Plaza – 19th Floor, New York, NY USA 10001
Phone
+1 (503) 670-7200
Address
Suite 230 – 17400 SW Upper Boones Ferry Rd, Durham, OR 97224