The current release of Fluid Air's patented batch control software, Factrol 3.1.7, has broad functionality while providing an intuitive operator interface. Factrol systems contain numerous features and safe guards intended to comply with regulatory and industry interpretation of CFR 21 Part 11. The following are just a few examples of the features offered in Factrol:

Password Security

• Security measures limit access to Factrol and other system programs to authorized personnel through.
• Unique user identification and password identify users for logon and signatures.
• Password expiration is configurable to customer specifications.
  

Database Security

• Database security, including encryption, for stricter compliance to CFR 21 Part 11.

Status Screen

• The graphical user interface provides users with the current status of critical machine functions.
• Manual control is available through the status screen.

Recipe Editor

• The Recipe Editor allows users to create and edit recipes. This window also allows users to apply signatures and activate recipes for download.
• Pre-defined recipes can be used to control the machine.
• The signature tab displays signatures that have previously been applied to the recipe.
• The Recipe Editor allows users to easily configure recipes and implement revision control.
• A recipe phase called the Marquee Function allows SOP's to be included in the recipe and acknowledged electronically.

Databrowser

• Factrol provides for viewing and printing of batch data and product recipes. Batch data can be exported in non-native formats (such as comma-delimited).
• Factrol provides the means to archive data according to the user's preferences. The user can choose to archive data immediately or schedule the data to be archived automatically.
• Electronic records can be easily accessed through the Data Browser. This tool allows users to customize the way batch data is viewed.
• Reports can be generated that include only signature information that was applied to a batch record. All data and message batch record printouts, as well as recipe printouts, contain the name of the signer(s), the applied time/date of the signature(s), the signature meaning(s), and user commentary(s).
• Databrowser allows users to create and save custom reports and graphs with batch data.

Electronic Batch Records

• Functionality to electronically create records and apply signatures in accordance with this CFR 21 Part 11.
• Ability to log and categorize events and data.
• Several audit trails capture user activities relating to electronic records.