Support for validation by APROL
The APROL process control system offers comprehensive functions for compliance with validation guidelines in accordance with the requirements of FDA 21 CFR Part 11 and the GAMP Forum (GAMP5). The functions listed below ensure efficient and compliant implementation of validation requirements in the APROL process control system:
Integrated engineering rights management for targeted assignment and control of access rights.
Automatic revision and change management that documents changes and makes them traceable.
ChangeControl logging for the engineering system to log changes seamlessly.
Tested standard software libraries that support the development of validated applications.
As-built documentation for complete representation of the implemented control system.
A variety of login mechanisms, including login name and password, chip cards, biometric procedures and transponders, for maximum security and flexibility.
Operator rights and password management, including password-based security mechanisms.
Long-term storage and re-readability of data.
Largely tamper-proof data logging in PDF documents to ensure the integrity and authenticity of the data.
System-level access rights management to prevent unauthorized access and maximize security.
Integrated AuditTrail that logs all operator interventions and thus ensures complete traceability.
Alarm and trend modules that enable effective monitoring and analysis of system data.
Continuous system monitoring and self-monitoring to continuously monitor the operation of the system and ensure stable performance.
Comprehensive system diagnostic tools that enable system errors to be quickly identified and corrected.
Control system-wide time synchronization that ensures a precise and uniform time basis for all system components.
B&R certification according to ISO 9001 and IEC 62443-4-1, which ensures the quality and reliability of the system at the highest level.
LDAP (Lightweight Directory Access Protocol) server for centralized authentication and authorization simplifies administration and increases security since all user information is stored in one place. LDAP supports various security mechanisms such as SSL/TLS encryption for secure communication. This is particularly important for validated systems, where the protection of sensitive data is a top priority. Simple integration into existing IT environments increases user-friendliness and security.