How AuditSafe works
A 45-second loop: universal 21 CFR Part 11 and GMP compliance, an audit trail that starts the moment raw data exists, and every package your lab uses inside one system.
Universal 21 CFR Part 11 and GMP compliance software. Raw data captured at source, analyzed in TotalLab or third-party software inside AuditSafe, with results and reports kept in one system your operators learn once.
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1 / 6 · The gap
Your instruments produce good data. Many were never built for a regulated lab.
Shared logins, raw files anyone can overwrite or delete, and no audit trail from the moment data is created.
The gap
Many lab instruments and analysis packages were never built for regulated work: shared logins, editable raw files and no audit trail from the moment data is created.
The layer
AuditSafe is universal 21 CFR Part 11 and GMP compliance software. It wraps TotalLab software, existing and legacy equipment, and third-party software, so you keep the hardware you have.
Sign in
Each user signs in with an individual, role-based login integrated with Windows Active Directory, so nobody shares an account.
Raw data at source
AuditSafe takes raw data directly from nearly any instrument, in any file type. The audit trail starts the moment the data exists, before it reaches analysis or your LIMS. Raw data, results and analysis reports can always be exported to your LIMS or any other system, in their original file types.
Analysis inside
Raw data is opened in TotalLab or third-party software such as Excel, Word, GraphPad Prism, MATLAB, Python and R from within AuditSafe, so every step is tracked and the results and analysis reports stay in the compliant system. Operators learn one system instead of several, cutting training time and the chance of error, with one AuditSafe license instead of a compliant edition for every package.
Sign off
Reviewers check the audit trail before release and approve the report with an electronic signature tied to their own credentials. The signed report stays in AuditSafe alongside its raw data.
AuditSafe ships with an in-person IQ/OQ validation package. See it working on your own equipment in a 30-minute walkthrough with a TotalLab compliance expert.
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