Each manufacturer has a set of unique needs and interpretation of part 11, Ellantra automation recognizes the demands of manufactirer & has created a solution that is flexible enough to address there requirements

21 CFR Part 11 applies to records in electronic form that are created,modified,maintained,archived,retrieved or transmitted

Benefits:

• Opening up new competitive advantage opportunities
• Cost effectively comply with Part 11
• User configurable Composite Batch Report
• Connectivity enabled for Line integration,MES
• FTView SE with inbuilt SQL & Windows functionality ensures data integrity
• Ease of maintenance since only one software used i.e. FTView SE

Industry Vertical : Pharmaceutical

Specific requirements : 21 CFR Part-11 Compliance

Challenges

• Online User Management
• Online Security Policy Modification
• Online Functionality Management
• Composite Report which includes Batch Event,Alarm & Audit Records
• Cost Effective Solution

Solution

• Configured FactoryTalk View SE with WIndows Operating system functionality & SQL Express edition as database to meet the requirement

Runtime Features

• Monitor & Control
• User Management
• User Group Management
• Functionality Management
• Security Policy
• Electronic Signature
• Batch Report-View & Print