---
title: '21CFR Software for aWLife'
date: '2026-07-08T12:35:34+02:00'
author: lisa.falocci
tags:
  - Conservabilità alimenti e farmaci
  - Analizzatori attività dell'acqua
  - STEROGLASS
  - Alimentare
  - Biologico e diagnostico
  - Cosmetico
  - Farmaceutico
type: prodotto
url: https://www.steroglass.it/en/21cfr-software-awlife
id: 2584
---

[STEROGLASS](https://www.steroglass.it/en/brands/steroglass)

# 21CFR Software for aWLife

[Analytical instruments](https://www.steroglass.it/en/analytical-instruments)

[Water activity meters](https://www.steroglass.it/en/analytical-instruments/water-activity-meters)

#### Contact our expert for more informations.

 ![](/sites/default/files/styles/scale_580x380/public/images/covers/prodotti/2026-07/software%20cfr%2021.jpg?itok=b6NOrfsR)

#### **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.

 [![audit trail](https://www.steroglass.it/sites/default/files/styles/crop_910x520/public/images/paragraphs/gallery/2026-07/Screenshot%202026-04-15%20085547.png?h=f03071a2&itok=S9tpdMkd "audit trail")](/sites/default/files/images/paragraphs/gallery/2026-07/Screenshot%202026-04-15%20085547.png)

## 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.

 [ Request a quote ](#) 

## 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.

 [ Request a quote ](#) 

### 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 |