ESA 21 CFR Part 11 Compliance

Trustworthy electronic records equivalent to paper records.
Secure time-stamped audit trails for all changes.
User access control with unique ID and password.
Electronic signatures for critical operations.
System validation for accuracy and reliability.
Encrypted data storage and secure backups.
Restricted access to authorized users only.
Operator and administrator training provided.
Compliance policies and procedures maintained.

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Product parameters Order Codes Relevant information

Feature	Description
▸REPORTING & PDF GENERATION
Design
No external tools required.	ESA HMI eliminates the need for third-party software to generate reports or PDFs. All functionalities are built-in, simplifying reporting and reducing dependencies.
Easy Report Formatting with Onsite Modifications	Support for real-time customization of layouts, data parameters, and formats directly onsite.
Report Format
No USB/memory card required.	Reports are saved directly to the system for seamless and secure data handling.
Predefined functions are available in the editor.	Includes templates and tools to create professional reports quickly and efficiently.
PDF File Options
Flexible File Generation	Reports can be combined into one file or generated separately for different scenarios.
Included Report Types	Includes: Batch set parameter Audit/Event Log Alarm History User Log Trends
Batch header	Start/Stop Timestamp: Logs exact times of batch events Start/Stop by User: Identifies the responsible operator Product Name/Code: Stamped batch-wise for traceability
Filter Options
Customizable Filters	Filter reports by batch, time, or user requirements to enhance relevance and accuracy.
Direct Print
Wi-Fi/Ethernet Printing	Print directly over network without external software or devices.
PDF Viewer
Inbuilt Viewer	Integrated viewer lets users read reports within the HMI system.
Electronic Signature
Time-Stamped and User-Specific	Every signature is time-stamped and linked to a user for full traceability.
Prevention of Data Falsification
Non-Editable Format	Reports are saved in a secure, read-only format to protect data authenticity.
▸AUDIT TRAIL
Data Entry Logs
Comprehensive User Action Tracking	Logs detailed user actions for traceability and accountability: Button/Switch Usage: Logs interface interactions Numerical value entries: Tracks before/after values and user identity Login/logout/change information: Records authentication and profile events User Account Management: Logs add, remove, lock/unlock actions Recipe Operations: Tracks save, modify, upload/download Alarm Actions: Logs enable, disable, acknowledgment System Actions: Tracks events like start, exit, and shutdown
Batch Log
Batch Start-Stop Log	Tracks the start and stop times of each batch operation.
Batch Duplication	Logs all instances of batch duplication for traceability and auditing.
Viewer Customization
Flexible Viewing and Reporting Options	Generate customized views and reports in PDF or print format to match user needs.
Retype Password for Critical Values
Enhanced Security for Critical Operations	Requires password re-entry for sensitive operations, enhancing security.
Add Comments During Online Operations
Real-Time Annotation Capability	Operators can add comments to buttons, events, or parameter values live during runtime.
Print/PDF by Filter
Filtered Report Generation	Generate reports/logs in PDF or print format based on time or batch filters.
▸USER MANAGEMENT
Password Complexity
Configurable Password Settings	Supports password lengths of 8-16 characters using alphanumeric and symbols for enhanced security.
Runtime Changes	Authorized users can modify passwords during system operation without interruptions.
RFID Login
Seamless Integration	Enables secure and quick user login via RFID, eliminating manual entry.
User Levels
Unlimited User Hierarchies	Supports an unrestricted number of user levels for precise access control.
Expiration and Warning Settings
Customizable Notifications	Password expiration alerts can be configured during runtime or in the editor for better compliance.
Log Display
Detailed Activity Tracking	Tracks user actions such as login/logout, password changes, and account updates.
Authorization Settings
Dynamic Access Control	Allows real-time updates to read/write permissions.
User Limit
No Restriction on User Accounts	Supports unlimited user accounts, scalable to any organization.
Force Password Change
Mandatory Updates for New Accounts	Ensures users update passwords immediately after account creation.
Account Lock/Unlock
Admin Control	Admins can unlock accounts as needed or permanently lock inactive ones.
Password Restrictions
Prohibition of Previously Used Passwords	Users are restricted from reusing a set number of previous passwords.
Electronic Signatures Per User
User-Specific E-Signatures	Each user can have a unique, configurable e-signature.
E-Sign Name	Allows a distinct signature name for each user for compliance and traceability.
▸SYSTEM
Backup & Restore
Complete System Backup	Create full system backups including configuration and data for disaster recovery.
Restoration on Alternate HMI	Restore backup files seamlessly on another ESA HMI without compatibility issues.
Non-Editable Backup Files	Backups are encrypted and non-editable to maintain system integrity.
Database
Proprietary Database	Uses a secure, non-editable proprietary ESA database ensuring reliability and compliance.
Third-Party Database Integration	Supports external databases (SQL, MS Access, Oracle) for infrastructure flexibility.
▸ADDITIONAL FEATURES
Multi-Language Support
Global Usability	Supports multiple languages for international use.
Runtime Language Switching	Languages can be changed during runtime without restarting the system.
Remote Access
Secure Remote Connectivity	Enables safe remote system access through secure connections.
Cross-Platform Monitoring and Control	Access the HMI system from desktop or mobile platforms for flexibility.
Video Viewer
Embedded Video Playback	Supports live or recorded video playback directly on the HMI screen.
Use Cases	Ideal for process monitoring, operator training, and troubleshooting.
Browser Support
Integrated Web Browser	Built-in browser enables access to online resources and applications.
Use Cases	Online Documentation: Quick access to manuals or troubleshooting guides. SCADA/IIoT Platforms: Real-time monitoring/control via web-based tools. Third-Party System Access: Interact with cloud-based dashboards and services.