Questions & Answers

Can the Optel Vision 21 CFR Part 11 Tool meet your IT requirements?

Situation

Recently Optel Vision was approached by a pharmaceutical company that required their 21 CFR Part 11 on their vision inspection system to have an added flexibility. Specifically, the connectivity of the 21 CFR Part 11 needed to be on an enterprise level, not on a machine level. Furthermore, data from the audit and batch files needed to be efficiently transferred on this level, and backup logs of configuration recipes and etc. needed to be encrypted and transferred to their facility’s network.

Solution

21 CFR Part 11

In designing the 21 CFR Part 11 Tool, Optel Vision factored in capabilities so that numerous requirements could be met. For example, the 21 CFR Part 11 Tool can provide either enterprise connectivity or machine connectivity, and it allows for various forms of data to be securely stored and transferred in standard or encrypted formats. Furthermore, Optel Vision offers different types of encryption so that each client’s specific requirements are met.