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ComSoft CFR 21 Part 11 software provides a fully validatable data management platform for organizations operating in FDA-regulated environments. Conformity with 21 CFR Part 11 requirements has been independently verified, making this software suitable for use in closed GMP systems within the regulated and biotechnology industries. Key compliance features include digital signature functionality and a complete audit trail for all user actions, ensuring that electronic records meet the integrity and traceability standards mandated by FDA regulations.

Compatible with both older 175 and 177 series and newer 175 and 176 series Testo data loggers, ComSoft CFR delivers graphic and tabular display of all measurement parameters, intuitive report creation, and secure data archiving. An essential software tool for regulated quality assurance and validation teams.

Features

• Digital signature and audit trail for the traceability of user activities offer maximum security and safety
• Storage of raw data in tamper-proof file format
• Detection of transfer errors using checksums

Applications

• Managing data loggers under FDA 21 CFR Part 11-compliant closed systems
• Digital signature and audit trail documentation for regulated GMP production
• Validated data archiving for pharmaceutical and biotechnology quality assurance
• Compliance reporting for testo 175/176/177 logger deployments