Other Technical Products

Additional AVEVA products incorporate features and functionality designed to facilitate the development of applications for use in FDA-regulated industries.

While it is outside the scope if this guide to document best practices for 21 CFR Part 11 for these additional products, following are summary descriptions of related AVEVA products and their capabilities relevant to regulated industries.

AVEVA Batch Management software effectively manages flexible batch operations found in the process industries, including life sciences, fine chemicals, and food and beverage/CPG. Adhering to the ISA-88 standards for batch control, it provides guidance and oversight to both recipe management and batch execution. Batch Management software coordinates everything with the plant control systems, interfaces with the operators, and directs batch activity, material flow, and production data to a historical database for a full electronic batch record (EBR). Customers can improve Compliance Governance through complete electronic system records for 'as planned' and 'as executed' information, including full Electronic Batch Records (EBR) in according with requirements found in FDA CFR 21, Part 11 regulations.

Operations & Performance Software— provides a configurable and highly scalable Manufacturing Execution Software System (MES) solution that is integrated with AVEVA System Platform IDE and InTouch HMI for unsurpassed connectivity and flexibility and can be applied to essentially any manufacturing or process industry. Customers gain accurate equipment setup according to site specific product specifications; central administration of process and product parameters; consistent interpretation of operating guidelines and procedures - all with complete electronic 'As-Built' historical records for documentation of products and processes.