Optel Vision Systems are
21 CFR Part 11 "Ready"

How does a company become compliant?

21 CFR Part 11 compliance encompasses several areas of production with the responsibility of compliance being placed on the production facility. For a company to be 21 CFR Part 11 compliant, they must put into place procedural controls (ex. SOP's), administrative controls and technical controls within their production facility that preserve the integrity of data compiled during the inspection of their products. Therefore, it is impossible for vendors of vision inspection products to offer turnkey "Part 11" compliant systems. In the case of Optel Vision, it is the features of the software that is built into our systems that supplies the technical controls for 21 CFR Part 11 compliance.

How can data from product inspections generated using an Optel Vision system be compliant?

From the moment inspection data has been generated, it must be safeguarded so that its integrity is maintained. Optel Vision's software supplies various controls to preserve the inspection data and to limit access to the management of the system. On Optel Vision systems, data from product inspections (batch trail files) and information relating to the management of the system (audit trail files) are all saved in the Flash memory of the system. One of the key 21 CFR Part 11 compliance issues is not whether this electronic data can be printed, but rather can the data be manipulated before it is printed. On Optel Vision systems, once the data has been saved in the Flash memory, the system applies an electronic signature (MD5 checksum) to the data. This is a form of validation that the data from product inspections or the information saved relating to the management of the system are valid. When this “signature” is applied to the data, this data can be viewed and/or printed, but it cannot be modified.

Optel Vision's software also has an additional feature: access level management. When saved information is protected by access level management, it can only be viewed and/or printed by personnel with a high level of access. Therefore, Optel Vision's software offers a “closed system” control since it grants or restricts users from having access to the data.

On Optel Vision systems all logs are automatically saved once a day. The time of day this occurs can be programmed specifically for each client (ex. at midnight). Each time the inspection of a batch of products is ended, the system automatically saves the data. This data contains all information concerning the total number of products inspected, total number of rejects, types of rejects, reasons for the rejects and the date and time of each reject. If a batch is running during the specified time for auto-log save, all data relating to that batch, up to that point, will be automatically saved.

Can Optel Vision systems function in "Hybrid Environments"?

Hybrid systems are environments where both electronic and paper-based records are used. If a system does not have an electronic signature feature, records of data must be printed out and signed. In the end, an electronic version will be saved in a durable storage media, and the printed copy containing the signature will also be stored. These two formats function together to create a “Hybrid System” for 21 CFR Part 11 compliance. Optel Vision systems can either function in an exclusively electronic or hybrid environment.