Batch Record Review/Release Software Solutions

TrackWise Batch Record delivers the flexibility to support batch record review and release functionality in a number of different business models. Supported scenarios span tracking and managing all production related information and the associated review and release process to the automated placement and removal of hold notices in a manufacturing organization with a sophisticated ERP.

Benefits:

• Ensures compliance with industry and government regulations and ISO standards
• Decreases product time-to-market by increasing release process efficiency
• Provides legal protection with complete records of batch review processes
• Provides seamless integration to EQMS functionality such as CAPAs and other quality activities
• Reduces risk of lost or incomplete lab data through a closed-loop tracking processes
• Provides flexible yet controlled environments through fully configurable process workflows
• Improves other quality and operating processes by integrating with other enterprise-level control systems such as EDMSs, EPRs, and LIMS
• Increases operational transparency through automated alerts, overview views using dashboard functionality, and extensive reporting capabilities
• Increases accountability though assignments, process step sign-offs, and automated audit trails