SUPPORT THE OPERATIONAL REQUIREMENTS OF A REGULATORY-COMPLIANT ENVIRONMENT-奥智品光学仪器

SUPPORT THE OPERATIONAL REQUIREMENTS OF A REGULATORY-COMPLIANT ENVIRONMENT

Compliance with complex regulatory requirements – such as FDA 21 CFR Part 11 – requires much more than password protection and restricting user access to files and folders on a corporate network.

ZONE3® Pro has built-in capabilities that directly support the operational requirements of a regulatory-compliant environment. Even if you are not under the jurisdiction of any of the regulatory agencies, these ZONE3 capabilities may ensure adherence to your Quality Management System’s internal requirements for a rigorous metrology environment.

There are nine components of ZONE3 for Regulated Environments –

User Access Permissions	Locking Projects
Audit Trails/Logging	LaunchPad
Task Based Programming	Error Handling
E-Signatures	Locked UCP Database
Expiring Sensor Qualifications

Additional solutions for qualifying OGP systems in a regulatory-compliant environment:

Equipment Installation Qualification (IQ) Service
The IQ includes analysis and report on verification of documentation, environment, test equipment, artifacts, contact materials and lubricants. Executor identification and deviation reports are provided. The service deliverables include completed documentation forms of equipment installation parameters that can be used towards compliance with FDA IQ requirements.

Equipment Operational Qualification (OQ) Service
The OQ service includes verification of documentation, Operational Verification, Process FMEA, Performance Evaluation, and a Preventive Maintenance Schedule. Executor identification and deviation reports are provided. The service deliverables include completed documentation forms of operational functionality that can be used towards further compliance with FDA OQ requirements.

产品优势

Allow or restrict access to specific functions of ZONE3, or specific software applications outside of ZONE3, based on the individual user
Prevent project access, modifications, or editing by unauthorized users
Easily apply an electronic signature to PDF output of measurement results from the Results Browser, controlled based on user permissions
Quickly examine the most recent audit log file, open other log files, search for specific event records and copy from or print log files

产品特点

User access permissions – linked to Windows® users – allow for permission sets down to the individual user level
Locking Projects – locks and secures an automated process that is part of a validated production or quality system
E-Signatures – in the form of Windows® user credentials or biometric data (e.g., fingerprint)
Log Viewer™ – an application which allows for viewing audit event records and log files for electronic records. These records consist of audit trail reports generated by ZONE3 and other OGP software

ZONE3 FOR REGULATED ENVIRONMENTS