21CFR Software for aWLife
Contact our expert for more informations.
Steroglass 21 CFR Software
The 21 CFR software developed by Steroglass is designed to support customers in achieving compliance with FDA 21 CFR Part 11 requirements, when used in conjunction with appropriate operating procedures and system validation.
The integration between the external software and the aWLife instrument enables the secure, traceable, and compliant management of electronic records, facilitating the implementation of the best practices required in regulated environments.
Regulatory Compliance
The software is designed to support compliance with the requirements of:
- FDA 21 CFR Part 11 – Electronic Records and Electronic Signatures
- EU GMP Annex 11 – Computerised Systems within the European regulatory framework
Note: Final regulatory compliance remains the responsibility of the user, who must implement appropriate procedures, controls, and system validation activities.
Benefits
-
DATA INTEGRITY
Data Integrity and Security
- Data acquisition with immediate record immutability.
- Protection against unauthorized modifications.
- Database designed to ensure data integrity and resistance to corruption.
-
Complete Audit trail
- Automatic tracking of all critical system and user activities, including identification of who performed each action and the reason for the change.
- Secure, tamper-proof event history.
- Supports regulatory audits and inspections.
-
User and Access Management
- User authentication through username and password with configurable complexity requirements (minimum password length, special characters, numeric digits, and uppercase letters).
- Management of user roles and access levels, with permissions assigned according to each user's authorization level.
- Unique identification of each operator.
-
Electronic Signatures
- Every critical operation requires an electronic signature for confirmation. The user must provide a reason for the action before it can be processed, generating a new Audit Trail entry.
Technical features
System Architecture
- Dedicated external software with a license assigned to a single aWLife unit.
- System designed for use in regulated environments.
- Compatible with the Microsoft® Windows operating system.
- The software must be installed on a customer-supplied Windows PC.
Ideal for pharmaceutical companies and regulated laboratories requiring secure, traceable, and FDA 21 CFR Part 11-compliant electronic data acquisition.
Industries
Food
Biological and diagnostic
Cosmetic
Pharmaceutical
Applications
Food and drug shelf-life
Product codes
| Steroglass code | Brand code |
|---|---|
| KFHF068565 | OPTIONAL SOFTWARE CFR 21 PART 11 |