VWorks Software Setup Guide : Using compliance features : About features that support compliance
About features that support compliance
About this topic
Read this topic to understand how VWorks Plus 14.1 features support compliance with Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11).
Note: These compliance features are not available in VWorks Standard.
Features that support 21 CFR Part 11
The FDA rules and guidelines for compliant electronic records and computerized systems require secure data handling. The following table lists the applicable VWorks Plus features.
Table Features that support compliance with 21 CFR Part 11
 
Feature
Description
For details, see...
Authentication, security, and user management
Prevent unauthorized access and unauthorized modification of records of interest. The Control Panel enables management of users, groups, roles, and privileges.
Configuration and administration guides
Secure Storaget
Provides secure storage with access control.
Control Panel system activity log
Records events that occur during a Control Panel session, for example, logging in, updates to users, groups, or roles, updates to licenses, and so forth.
Backup and restore procedures for the software and Secure Storaget.
Provide procedures required for disaster recovery planning.
VWorks activity logs
Record events that occur during a VWorks session. The logs include the Main log, Pipette log, and Time Constraints log.
The Diagnostics software for each device displays a profile activity log, which is also stored in the Main Log.
Viewing logs
Audit trails and reports
Provides traceability for records of interest, documenting who did what and when.
An audit file is logged for each record of interest.
Audit trails and audit trail reports
VWorks records of interest
Record state tracking
Provides control of records that transition through development, validation and released states to ensure record integrity and traceability. The software also increments the version of a record of interest each time a change is saved.
Managing record states
Electronic signatures
Enables users to sign off on a record before transitioning it to the next record state. If the Experiments Editor is in use, this feature enables signing to close an experiment ID.
Using E-Signatures
Tamper detection
Detects corrupted records and records that have been modified externally from VWorks Plus.
Detecting tampering
Exporting and importing protocols
Provides a means to export protocols and associated components to an archive file (.vzp) that can be used to transport protocols between computers, back up and recover protocols, and facilitate troubleshooting problems with protocols and other files when seeking assistance from Agilent Technical Support.
Exporting and importing protocols and associated records
Backup and Restore features
Provides a means to backup and restore the following files from an archive file (.vbk).
• Labware entries
• Labware classes
• Liquid classes
• Pipetting techniques
• Database file (.sql) for labware inventory
Backing up and restoring VWorks files