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Owner's Manual for Honeywell models including: HCiR series CFR Part 11 FDA Electronic Records Signatures, HCiR series, CFR Part 11 FDA Electronic Records Signatures, FDA Electronic Records Signatures, Electronic Records Signatures, Records Signatures, Signatures
23 hours ago — Password protected individual unique user account. • Password complexity ... COMPLIANCE GUIDE. Page 2. Solution Note-HCiR series for PHARMA | www.honeywell.com ...
1 giorno fa — • User Login/Logout. • Configurable block by . • Old value and ... COMPLIANCE GUIDE. Page 2. Solution Note-HCiR series for PHARMA | www.honeywell ...
COMPLIANCE GUIDE. Page 2. Solution Note-HCiR series for PHARMA | www.honeywell ... verification of operating instructions. FAST. A unique approach to project ...
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DocumentDocumentFDA 21 CFR PART 11 COMPLIANCE GUIDE Using Honeywell HCiR series to create 21 CFR Part 11 FDA compliant Application: Electronic Records & Signatures Honeywell Modular system solution "Controller + HMI" are 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 to this application programming Environment, HCiR allow 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 password for user accounts · Password validity · Multiple password level for each User Authority AUDIT TRAIL(TRACKING): · Non-editable Audit Trail Data Format · The time-stamp of the modification of the parameter value and user making the modification · The Audit Trail records following details: · User creation · User Login/Logout · Configurable block by Administrator · Old value and new value of 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, MasterLogic PLC by followings: · 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 event(trail). And also these data are available to save into SD card and 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 on-line thru a printer to support PCL format. PRODUCT LINE 1024 X 768 15" HCiRX15-FE-FD-NC 12.1" HCiRX12-AE-FD-NC 10.4" 8.4" 5.6" 800 X 600 HCiRX12-TE-FD-NC HCiRX10-TE-FD-NC HCiRX08-TE-FD-NC 640 X 480T HCiRX05-TE-FD-NC WIDE - 10.1" 7" 5" 800 X 480 HCiRW10-TE-FD-NC HCiRW07-TE-FD-NC HCiRW05-TE-FD-NC Solution Note-HCiR series for PHARMA | www.honeywell.com | 2 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 remove risks and accelerate 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 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 2101 City West Blvd, Houston, TX 77042 Honeywell House, Skimped Hill Lane Bracknell, Berkshire, England RG12 1EB UK Building #1, 555 Huanke Road, Zhangjiang Hi-Tech Industrial Park, Pudong New Area, Shanghai 201203 process.honeywell.com 01/24 © 2024 Honeywell International Inc.