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CFR21 Part 11 and NADCAP AMS2750E Requirements: Historical Data files (Data Log) and Digital Signatures

Along with EnVision’s digital signatures, the security features, software life cycle and validation documentation provide CFR21 Part 11 compliance. The Security features are not just applicable to the pharmaceutical industry; EnVision meets the requirements of NADCAP AMS2750E as well as most any other industry standard that requires secure data files, audit trails and authenticated logins to initiate process changes can take advantage of these features

The Electronic Signatures grid, below the data grid, is used to electronically sign data files eliminating the need for paper signatures. Data Files can be signed only by users with the proper log in and user access.  EnVision can validate any electronic signature and verify if the original data file (when signed) has been altered in any way.

Envision CFR21 part 11

NOTE: Although EnVision is compliant with 21 CFR Part 11 requirements for electronic records when configured appropriately, it is the end user’s responsibility to validate that EnVision, along with all the other components & processes in the system, are in compliance with appropriate CFR-21 part 11 regulations.

See below for more information on 21 CFR part 11 and how EnVision is in compliance.

21 CFR Part 11 History

21 CFR Part 11 began in 1991 when the pharmaceutical industry requested guidance from the FDA regarding the best way to implement electronic systems in manufacturing process and meet FDA approval.

The FDC rule was announced in 1997. A large portion of the rule is related to electronic records with approx. 20% covering electronic signatures.

Part 6 provides the definition for an electronic record, which covers any document or data that is created, maintained, modified, retrieved, archived or transmitted electronically. The electronic signature part of the rule informs the reader about the requirements for acceptable signatures.

A 21 CFR part 11 systems provides the means to audit and track all user interface and system operations. This ensures accurate repeatable electronic record keeping and verification of all steps in the electronic record keeping process.

The final rule in text and .pdf format is available at http://www.fda.gov/ora/compliance_ref/part11/

EnVision 21 CFR Part 11 Features

User Access:
Access to EnVision software features are configured by the administrator in the Security   Configuration, “Rights and Options” portion of the software (70+ rights). Software features are accessible only when the proper user level is met and the required userID and password are entered.

EnVision Security Settings

User Login:
Feature level access as well as user actions that will change the process (i.e. setpoint changes, alarm acknowledgement, start/stop data log, etc.) require login to authenticate the user before the action is carried out.

Audit Trail:
EnVision keeps a daily audit trail of all functions initiated by the software or a user. UserID, full user name, user description, user comment as well as the action is written to the audit trail. All login failures are written to the audit trail file as well. Audit trail files are encrypted for “tamper proof” operation and can only be viewed by the EnVision software. Audit trails may be printed and exported in .csv format.

EnVision Audit Trail

Electronic Signatures:
All data files can be electronically signed with the proper user access rights and authenticated login. A "message digest" is calculated for each file and is used for signature/file verification. If a data file is tampered with or altered, the signature verification function will alert the user. The original data file is not altered in any way.


Page Navigation - Jump to the specific page in the EnVision Tour
 

1. EnVision Navigation
2. Device Thumbnails Overview
3. Digital Values
4. System Alarms
5. EnVision Device Alarms
6. PC based Alarm Relay Output
7. General and Service Device Notes
8. Real-Time Trends
9. Single Loop Tuning
10. Data Logging Overview
11. System Data Logging
12. Device Data Logging / Historical Data File
13. Logging Overview Monitor
14. Historical Data File Viewing
15. Searching Historical Data Files
16. Historical Data File Trend Plot
17. CFR21 Part 11 and NADCAP AMS2750E: Historical Data files (Data Log) and Digital Signatures
18. Orion-Mi / nCompass CM Detail View

   

19. Orion-Mi / nCompass CM Detail View Tab
20. Orion-Mi / nCompass CM Detail View: Auto Tune and Auto/Manual Tabs

21. Orion-Mi / nCompass CM Data Logging Tab
22 Orion-Mi / nCompass CM Schedules Tab (Ramp/Soak Profiles)
23. Orion-Mi / nCompass CM Profile/Schedules: Run, Stop & Hold Profile Schedules

24. Orion-Mi / nCompass CM Schedule Editor Overview
25. Orion-Mi / nCompass CM Schedule Editor: Guaranteed Soak, Loops Active and Auto Start
26. Orion-Mi / nCompass CM Schedule Editor: Stage "Wait For"

27. Orion-Mi / nCompass CM Schedule Editor: Schedule Notes
28. Orion-Mi / nCompass CM - Setup Tab
29. Orion-Mi / nCompass CM Detail View - Setup/IO Monitor
30. Orion-Mi / nCompass CM Detail View - Setup/Schedule Options

 
 
 
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