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FDA 21 CFR Part 11
Agenda
• Introduction
• Security System
• Events
• Alarms
• Q&A
Introduction
Introduction
The 21 CFR Part 11 regulations from the Food and Drug
Administration (FDA) sets forth the criteria under whic...
Introduction
 The software (SCADA) cannot state that it complies with FDA Part 11. The software shall
provide the necessa...
Introduction
 An Open System (such as the World Wide Web or Web) requires encryption for
electronic reports and for the E...
Introduction
 The system administrator must be able to access the user account settings to create
new accounts, lockout u...
Security System
Security System
 Modes
 Groups Settings
 Users Settings
 Electronic Signature
 Log-on and Log-off
 Security System B...
Events
Events
 Event Logger
 Alarm/Event Control (Event mode)
 Event History Format
 SendEvent() built-in function
Alarms
Alarms
 Alarm task
 Alarm/Event Control (Alarm mode)
 Event History Format
 User Comments
Q & A
How to contact InduSoft
Email
(US) info@indusoft.com
(Brazil) info@indusoft.com.br
(Germany) info@indusoft.com.de
Support support@indusoft.com
Web...
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InduSoft Web Studio and Meeting FDA 21 CFR Part 11 Regulations for Food, Beverage, and Pharmaceutical Manufacturing

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InduSoft Web Studio is a SCADA and HMI software platform that has been used for applications designed to meet international food and beverage safety standards, such as FDA 21 CFR Part 11, EU Annex 11, GAMP, and more. Any application that must adhere to standards of government or industry regulation requires tools and functionality for traceability and data verification in the SCADA software it’s built. InduSoft Web Studio has proven through multiple applications and several top-level audits in multiple industries that it possesses the tools necessary for tracking, traceability, batch and recipe reporting, and data verification.

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InduSoft Web Studio and Meeting FDA 21 CFR Part 11 Regulations for Food, Beverage, and Pharmaceutical Manufacturing

  1. 1. FDA 21 CFR Part 11
  2. 2. Agenda • Introduction • Security System • Events • Alarms • Q&A
  3. 3. Introduction
  4. 4. Introduction The 21 CFR Part 11 regulations from the Food and Drug Administration (FDA) sets forth the criteria under which the agency considers electronic records and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
  5. 5. Introduction  The software (SCADA) cannot state that it complies with FDA Part 11. The software shall provide the necessary tools to allow a user to create a system (application) that is compliant with FDA Part 11.  The SCADA system does not “force” the user to build an application compliant with FDA 21 CFR Part 11. Such compliance is optional during application development.  An Electronic Record is any data that can be saved as electronic media and retrieved later. An Electronic Signature is a specific type of Electronic Record that contains the following information:  o Timestamp  o User name  o Meaning of the signature A Digital Signature is a specific type of Electronic Signature, in which the data is encrypted.
  6. 6. Introduction  An Open System (such as the World Wide Web or Web) requires encryption for electronic reports and for the Electronic Signature (Digital Signature).  Electronic records are associated with events (such as tag changes, load recipes, and so forth), whether the user triggered the event or not. Electronic signatures are associated with actions triggered by the user (such as pressing a button, changing a slider, entering a set-point manually, and so forth).  The Part 11 rule does not mention whether the electronic records must be stored in a standard database (such as Oracle, SQL Server, etc.) or in a proprietary format. When you use a standard database, the responsibility for guaranteeing the confidentiality of the database relies on the database features for data protection (such as password protected databases)
  7. 7. Introduction  The system administrator must be able to access the user account settings to create new accounts, lockout users, and de-authorize them. These changes can be logged, even if the runtime is not running.  Nobody (not even the System Administrator) has access to the password of any user.
  8. 8. Security System
  9. 9. Security System  Modes  Groups Settings  Users Settings  Electronic Signature  Log-on and Log-off  Security System Built-in Functions
  10. 10. Events
  11. 11. Events  Event Logger  Alarm/Event Control (Event mode)  Event History Format  SendEvent() built-in function
  12. 12. Alarms
  13. 13. Alarms  Alarm task  Alarm/Event Control (Alarm mode)  Event History Format  User Comments
  14. 14. Q & A
  15. 15. How to contact InduSoft
  16. 16. Email (US) info@indusoft.com (Brazil) info@indusoft.com.br (Germany) info@indusoft.com.de Support support@indusoft.com Web site (English) www.indusoft.com (Portuguese) www.indusoft.com.br (German) www.indusoft.com.de Phone +1 (512) 349-0334 (US) +55 (11) 3293-9139 (Brazil) +49 (0) 6227-732510 (Germany) Toll-Free 877-INDUSOFT (877-463-8763) Fax +1 (512) 349-0375 Contact InduSoft Today Germany USA Brazil
  17. 17. Thank you!

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