DATABASE SECURITY and PART 11 COMPLIANCE

We are pleased to announce that our Tool Management II (TM2) now supports the Pervasive SQL V8 database. Support for the Pervasive SQL V8 database engine provides the enhanced database security necessary for Part 11 compliance including:

DATABASE SECURITY – As an essential component of CFR 21 Part 11 compliance, database security is necessary from both within the application and external to the application. Utilization of the Pervasive SQL V8 database engine will provide complete data security across all access methods. In addition to the powerful Database Login, Pervasive SQL V8 features strong, 128-bit encryption between the workstation and server, along with on-disk encryption. For more information see the related product sheet document “PervasiveSQL_Product_Sheet.pdf” or visit the Pervasive website at www.pervasive.com/psql/

Prevent Access to Data at the Operating System Level – Establish access rights that prevent users from deleting, renaming or moving data files while still providing full functionality from within the TM2 application.

Electronic Audit – TM2 provides audit trail capability at the application level with secure, computer generated, time-stamped audit trails that record the date and time of operator entries and actions that modify or delete entries.  The optional Pervasive AuditMaster monitoring solution provides audit trail capability at the database level by   monitoring and reporting all activity occurring in the database regardless of the application.  Please note: AuditMaster is only available for network systems on Windows operating systems.  For more information see the product sheet document “AuditMaster_Product_Sheet.pdf”.    

Date and Time Stamps – Application level, password protected access to date and time stamp information is viewable on-screen for most tables. Determine immediately, the most recent date, time and user to modify every record in a table.

User Login and Password Security – Both application and database password protection ensure that only authorized individuals can use the system, access the operation, alter a record, or perform the operation at hand.  The TM2 application includes twenty-six (26) different “rights” that can be assigned to or removed from each user ID.  For more information see the product sheet document “Security_Solution_Sheet.pdf.”

Validation Documents – The optional TM2 Validation Package provides a complete set of documents including executable IQ and OQ documents as well as a Summary Report and a CFR 21 Part 11 Compliance Statement.

Error Checking - The software has built-in checks to prevent input of invalid data and utilizes lookup tables to ensure consistent data entry values.