Honeywell HCiR series CFR Part 11 FDA Electronic Records & Signatures
Using Honeywell HCiR series to create 21 CFR Part 11 FDA compliant Application: Electronic Records & Signatures
Honeywell Modular system solution “Controller + HMI” is an optimized and outstanding solution for Pharmaceutical and Life Science manufacturers requiring a cost-effective system that is fully compliant with 21 CFR Part 11 FDA. Honeywell HCiR series can reach this application programming Environment, HCiR allows the system to be validated to the 21 CFR Part11 regulations by featuring functions and features that enable.
USER MANAGEMENT FUNCTIONALITIES :
- Password-protected individual unique user account.
- Password complexity
- Configure a character count for password with Flexibility
- Configurable trials to modify passwords for user accounts
- Password validity
- Multiple password levels for each User Authority
AUDIT TRAIL(TRACKING):
- Non-editable Audit Trail Data Format
- The time-stamp of the modification of the parameter value and the user making the modification
- The Audit Trail records the following details:
- User creation
- User Login/Logout
- Configurable block by Administrator
- The old value and the new value of the parameter change
- The time stamp of each event
SYSTEM DATA AND DATA BACKUP:
HCiR offers the basic connectivity for data exchange with Honeywell solutions, Experion, ControlEdge PLC, RTU, HC900, and MasterLogthe ic PLC by following:
- Communication: Modbus
- Data file Transfer(FTP)
- USB, SD card
ELECTRONIC DATA RECORD AND STORAGE:
Review of the reports on the HMI Screen for Production, Alarms, and eve events soAnd also these data are available to save into an SD card and the user can copy/move the data to external memory(USB).
VIEW OF THE ALARM/EVENT DATA :
Detected alarm/event data is stored in internal memory. Capture and Printing: The captured screen is available to print out online through a printer to support PCL format.
PRODUCT LINE
COMPLIANT
Solutions to facilitate validation and reduce compliance costs with system self-documentation, electronic change management of control configuration, 21 CFR part 11 compliance, and enforcement and verification of operating instructions.
FAST
A unique approach to project execution with LEAPTM project execution and technologies such as our Universal I/O removes risks and accelerates schedules.
VIRTUAL READY
A Virtual Engineering Platform allows for virtualization and simulation of all DCS components for cost-effective change implementation in a validated environment.
EXPERIENCED
More than decades working with the world’s leading pharma businesses, with specialists who bring a lifetime’s experience in pharma.
SCALABLE
We are delivering the most advanced technologies to the smallest and largest operations, with flexible solutions.
SECURE
Industry-leading cyber security, access control, and protection against message flooding and denial of service to ensure system availability.
For more information
process.honeywell.com
Honeywell Process Solutions
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