In SCADA we have specific & customized solutions for Pharmaceuticals Industry. Whereas PC-based & HMI-based solutions are available.

Introduction to 21 CFR Part 11 FA Part 1 Compliance

•  21 CFR Part II is an important section of the Code of Federal Regulations.
• 21 CFR Part II deals with rules for electronic records and electronic signatures as set out by the FDA
• It needs to be understood that each title and part of the CFR denotes a certain industry or activity
• In this instance, 21 CFR is the FDA title for PHARMA and medical devices, while Part II relates to a specific activity, namely electronic signatures, and record
• Under the broad umbrella of pharmaceuticals and medical devices, a host of activities are included.
• In 1999, computerized systems that are used in clinical trials came under 21 CFR Part II.