Overview

The Testo ComSoft 21 CFR Part 11 software is an intuitive and fully validatable solution specifically designed for the stringent requirements of the pharmaceutical industry. This powerful software ensures compliance with FDA regulations within a closed system, with its conformity to CFR directives independently confirmed.

It allows for the comprehensive graphic and tabular display of all measurement parameters, facilitating effortless data analysis and report generation. From managing critical data to ensuring maximum security and traceability, ComSoft 21 CFR Part 11 streamlines your workflow while upholding the highest industry standards.

Why It Matters

In highly regulated environments like pharmaceuticals, data integrity, security, and traceability are paramount. This software is essential for maintaining compliance with FDA 21 CFR Part 11, providing a robust framework for electronic records and signatures. It safeguards your data against tampering, ensures comprehensive audit trails, and simplifies the validation process, making it indispensable for critical data logging applications.

What's Included

• Testo ComSoft 21 CFR Part 11 Software (download with registration) for PC installation
• Instruction manual

Features & Benefits

• Digital Signature & Audit Trail: Ensures traceability of user activities, offering maximum security and safety.
• Tamper-Proof Data Storage: Stores raw data in a secure file format, preventing unauthorized alterations.
• Error Detection: Utilizes checksums to detect transfer errors, maintaining data integrity.
• Inactivity Lockout: Prevents unauthorized access by automatically locking the system after periods of inactivity.
• Intuitive User Interface: Guides users through work steps, enabling effortless data export, report creation, and analysis.
• Comprehensive Data Evaluation: Displays and evaluates all recorded measurement parameters in both graphic and tabular formats.
• Customizable Measurement Menus: Tailor menus and organize data loggers into clear tree structures based on application site.
• Advanced Functions: Includes online measurement capabilities, formula creation, and scientific-statistical evaluation (min./max./mean value, limit value violation).

Applications

• Pharmaceutical manufacturing and storage monitoring
• Validation processes for regulated environments
• Laboratory data management
• Quality control and assurance in sensitive industries
• Monitoring critical transportation routes for temperature-sensitive goods

Tradie Pro Tip

"For pharmaceutical applications, ensure your Testo data loggers are regularly calibrated and integrated seamlessly with ComSoft 21 CFR Part 11. This proactive approach not only maintains compliance but also provides an unchallengeable audit trail for all your critical environmental data, saving you time and stress during inspections."

Technical Specifications

Pair With

• Testo 175H1 Temperature and Humidity Data Logger
• Testo 175T1 Temperature Data Logger
• Testo 176H1 Four-channel Humidity and Temperature Data Logger

Enhance Your Data Compliance

Elevate your data compliance and security. Purchase the Testo ComSoft 21 CFR Part 11 software today and ensure your pharmaceutical operations meet the highest standards of data integrity.