- Date: 21 Nov 2006
- Unit: Kaye Validator
- Software Version: Version 3.1
- Stability Chambers
- Depyrogenation Tunnels
Kaye Validator software version 3.0 is the next major upgrade in a long line of software improvements designed to ensure ever changing regulatory compliance and more efficient and effective validation.
Kaye Validator software version 3.1 provides significant operator time saving features over earlier releases, including:
Network installation and management
- System administrators can now have fully automatic management of passwords, audit trails and data files across their validation groups.
New report wizard
- Added flexibility and convenience in merging data files from multiple Validator and ValProbe studies
- Easy to use and simplified cycle based reporting dramatically speeds up complex reporting, avoiding the use of Excel.
- Graphing greatly improved. Users can rapidly create custom regulatory-ready graph reports.
- Permits USB connection between PC and Validator
- Storage and data upload times improved three to five fold.
Full validation documentation
- Full IQ/OQ and SOP are available.
- Change control documents also available for upgrading from previous versions.
- Validation Reference describes design validation (qualification) performed.
Completely new functionality has been added to version 3.0 to satisfy the needs of growing Validation departments in managing their Kaye Validation Systems.
All critical data to a Validation including passwords, audit trails, qualification and calibration records can now be automatically stored at a network location defined at software installation time by a system administrator.
At software installation the system administrator can choose to enable network install and can predefine settings such as password database location, data file locations and other site options. The user will then install the software from the network and be automatically configured as per the system administrator’s selections.
Synchronisation is also supported. The user can run the Validation system disconnected from the network and at the next opportunity the software will automatically update the network files and database with any changes from the disconnected session.
Backwards compatibility is maintained, and the user can choose not to utilize the network features.
In addition to passwords now being centrally managed in a network installed version, users can now explicitly set permissions for each user by possible action.
With the network capability, audit trails have been improved to allow centralized management, searching and printing of department wide audit trails from any connected PC. The sort and find utilities have been significantly improved.
The monitoring and protection of database files stored on the local PC and network has been improved. There is notification to the user and logged entries in the audit trail if attempts were made to tamper with files.
For applications where 21 CFR part 11 is not needed, the system administrator has the ability to disable the password system for all users.
A new feature is the ability to combine or merge reports from several Validators or ValProbes providing the validations were run concurrently. A typical example would be during a freeze dryer validation where two Validators are needed, or if a ValProbe Pressure logger is used along side Validator temperatures for EN554 reports
Post qualification reporting
Validator users can for the first time gain access to the flexible and user friendly Kaye ValProbe reporting system.
In addition to preserving the existing Validator group and event structure, users can now add unlimited cycles and up to 25 groups during the reporting phase.
Cycles are like events – the qualification data is separated into distinct phases and summary reports can be generated for each cycle.
The user can generate regulatory accepted reports including detailed and summary reports by group and cycle (interval data). Graph reports have been improved allowing more inputs and improved access to graph properties such as colors and data limit lines.
Report templates are automatically created allowing the user to reprint an exact copy of the report at a later date, or saved to a template for use in subsequent validation studies, providing significant time savings for system operators.
Groups simplify calculations
Groups can now be defined post qualification during the reporting phase. In addition to the four groups allowed in the pre-validation Validator setup, up to 25 groups can be reported. Groups can define their own calculations and graphs allowing great flexibility in reporting.
A powerful graphing utility within the system software greatly simplifies process analysis and reporting. Sliding vertical axis enable the operator to flag and define process transition points, eliminating unnecessary reporting and streamlining the review process. Version 1.40 features increased flexibility for graph customization, including specifying X and Y axis ranges, background colors, line styles and labeled limit lines.
Validator 3.0 is supported with documentation that verifies a fully validated system, including software, hardware and firmware. A Validation Reference provides a comprehensive overview of the GE Sensing Quality Policy, description of ISO 9001 implementation and support procedures, and standards for system development, testing and maintenance. The Installation Qualification/Operational Qualification Protocol defines a set of procedures to ensure that the ValProbe system is properly installed, qualified and operated according to cGMP requirements. Also available is an example SOP.