In Computerized System Validation CS describes the system’s customizable settings and parameters, ensuring that the system can be properly tailored to its intended use in a regulated environment, such as pharmaceutical manufacturing.
Key Elements of Configuration Specifications in CSV
1. System Configuration Overview:
- A high-level description of the system components, modules, and their relationships.
- Defines how the system will be set up, including hardware and software configurations, networks, and databases.
2. User Accounts and Security Settings:
- Details on how user roles, permissions, and access levels will be configured to ensure compliance with data integrity and security requirements, such as 21 CFR Part 11 and EU Annex 11.
- Includes password policies, session timeouts, and access control mechanisms to ensure that only authorized personnel can access specific system functions.
3. Data Fields and Structure:
- Specifies the configuration of data fields, forms, templates, and records within the system.
- Defines how data will be captured, processed, and stored to meet operational and regulatory needs.
4. Workflows and Process Settings:
- Customization of workflows and process flows within the system, such as batch records, audit trails, and approval processes.
- Ensures that system operations follow predefined steps and reflect standard operating procedures (SOPs) and good manufacturing practices (GMP).
5. Reports and Outputs:
- Defines the format and parameters for generating system reports, such as batch production records, deviation reports, or audit logs.
- Customizes how data is displayed or exported, including filters, sorting, and formatting options.
6. Interfaces and Integrations:
- Specifies the configuration of system interfaces, such as data exchange between the computerized system and other external systems (e.g., ERP, LIMS, SCADA).
- Ensures proper data transfer, communication protocols, and system synchronization for integrated systems.
7. Alarms, Alerts, and Notifications:
- Configuration of alarms and alerts for system events, deviations, or exceptions (e.g., temperature excursions, system errors).
- Customizes notification settings, such as email or SMS alerts, based on defined conditions.
8. Audit Trails and Logging:
- Specifies how the system will log user activities, changes, and transactions.
- Configures audit trail settings to meet regulatory requirements for traceability and recordkeeping.
9. Backup and Recovery Settings:
- Specifies how system data will be backed up and restored in the event of system failure.
- Configures schedules and locations for backups to ensure data integrity and availability.
