About 21 CFR Part 11 Projects

Importance of 21 CFR Part 11 Projects

To resolve the automation and control issues, industries use the ever changing technologies in control systems for efficient production or manufacturing processes.

These requires the high quality and reliable control systems. New trends in 21 CFR Part 11 Projects deals with latest control devices and communication protocols to control field devices like control valves and other final control elements. Some of the smart devices or instruments used in automated industry has the ability to control the processes and also communication capabilities without interfacing to other field level control devices like PLC’s.

21 cfr part 11 SCADA
21 cfr part 11 HMI

Secure Processes and Efficient validation processes –

You can depend on our SCADA solution. Our Comprehensive SCADA solution can provide cost effective validation and robust operation of your pharmaceutical automation projects, while constantly sticking to strict laws and validation processes.

Avanew Automation here to offer you a machine level as well as Plant level (Centralised) SCADA package which provides the full compliance to US FDA 21 CFR Part 11 norms

Quick overview of SCADA features :

More than 300 communication protocols
GAMP software
User Administration
Audit Trials
Electronic records and electronic signatures

Alarms Management
Batch Control
Trending and Analysis
Recipe management

US FDA 21 CFR Part 11 Compliant Panel HMIs for your machines

The costs of not switching over to electronic record-keeping and associated electronic signatures are too great for many in the affected industries to ignore. By switching to electronic solutions, companies expect to benefit in many ways.

We, at Avanew Automation are here to offer you an HMI which provides the full compliance to US FDA 21 CFR Part 11 norms. This is the most efficient and economical way to enable your production machines to “21 CFR Part 11” compliant.