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.

1. FDA 21 CFR Part 11

2. Agenda
• Introduction
• Security System
• Events
• Alarms
• Q&A

3. Introduction

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. 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. 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. 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. Security System

9. Security System
 Modes
 Groups Settings
 Users Settings
 Electronic Signature
 Log-on and Log-off
 Security System Built-in Functions

10. Events

11. Events
 Event Logger
 Alarm/Event Control (Event mode)
 Event History Format
 SendEvent() built-in function

12. Alarms

13. Alarms
 Alarm task
 Alarm/Event Control (Alarm mode)
 Event History Format
 User Comments

14. Q & A

15. How to contact InduSoft

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
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USA
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17. Thank you!