FDA Validation

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

locations

Contact

Phone

+1 (604) 574-7790

Email

info@escautomation.com

Address

5265 185A Street, Surrey, BC V3S 7A4

Phone

+1 (403) 270-0333

Email

info@escautomation.com

Address

2588 27 St NE, Calgary, AB T1Y 7G1

Phone

+1 (780) 448-9152

Email

info@escautomation.com

Address

18220 – 102 Ave NW, Edmonton, AB T5S 1S7

Phone

+1 (888) 756 3008

Email

info@escautomation.com

Address

3057 Barons Rd, Nanaimo, BC V9T 3Y6

Phone

+1 (647) 789-2600

Email

info@escautomation.com

Address

100-5525 Eglinton Ave W, Etobicoke, ON M9C 5K5

Phone

+1 (425) 487-8613

Email

info@escautomation.com

Address

 19310 N Creek Pkwy, Bothell, WA 98011

Phone

+1 (732) 355-7177

Email

info@escautomation.com

Address

10 Centre Drive, Monroe Township, N.J. USA, 08831

Phone

+1 (212) 629-8844

Email

info@escautomation.com

Address

5 Penn Plaza – 19th Floor, New York, NY USA 10001

Phone

+1 (503) 670-7200

Email

info@escautomation.com

Address

Suite 230 – 17400 SW Upper Boones Ferry Rd, Durham, OR 97224