AuditSafe21 CFR Part 11 compliance overlay
For QC, QA and validation teams. Every TotalLab analysis product has a version for regulated labs. It is the same software you trial, running inside AuditSafe, our compliance layer. Together they give you audit trails, electronic signatures, user permissions and protected raw data for FDA 21 CFR Part 11, EU Annex 11 and GMP.
There is no separate "GxP edition" to buy for each product. You license the analysis software you need, add AuditSafe, and that combination is the compliant system.
21 CFR Part 11 compliant western blot, SDS-PAGE and 1D gel densitometry
Phoretix 1D GMP version21 CFR Part 11 compliant colony counting and zone of inhibition measurement
Colony Counter Part 11 versionGMP-compliant ELISA and plate reader analysis with 4PL and 5PL curve fits
PlateLogic21 CFR Part 11 compliant HCP antibody coverage by 2D western blot
SpotMap 2D21 CFR Part 11 ready LC-MS host cell protein identification and quantitation
SpotMap MS21 CFR Part 11 compliant 2D gel and 2D-DIGE differential expression analysis
SameSpotsGMP-compliant 1D band matching, fingerprinting and strain typing
CLIQS 1D ProCompliant longitudinal trending of assay and control data
TrendLabCompliant kinetic virus infectivity and titer analysis
TiterKinetixCompliant array and dot blot analysis, including multichannel images
Phoretix ArrayCompliant general-purpose scientific image analysis
Phoretix ToolboxMost of the labs that send us a URS are dealing with one of these four situations.
CLIQS 21 CFR, CLIQS Version Control and TotalLab Quant GxP are no longer supported, and older builds won't move to Windows 11. Phoretix 1D inside AuditSafe replaces them, and Phoretix 1D opens TotalLab Quant, TL120 and TL100 project files.
An imager that saves to an open folder or a spreadsheet with no audit trail is a common finding. AuditSafe brings the existing instrument software or Excel workbook under control without replacing the hardware.
Development used the standard software; QC needs the same analysis under Part 11. Because the compliant version is the same release run inside AuditSafe, the method and its templates move across unchanged.
Validated workstations are often taken off the internet or moved to an isolated OT network. AuditSafe runs on your own server, needs no cloud connection and can be activated completely offline.
We built our first 21 CFR Part 11 software in 2009. For years each product had its own GxP edition. AuditSafe replaced those editions, and the change was deliberate.
Login, audit trail and signatures work the same way whether the analyst opens Phoretix 1D, PlateLogic or an Excel workbook. Your QA team qualifies those controls once, not once per program.
Check out a project, do the analysis, check it back in, request sign-off. The steps are identical across every product in the lab, which cuts training time and operator error.
The analysis software inside AuditSafe is the current release, the same one R&D uses, so there is no separate regulated build to fall behind. Method transfer from development to QC gets simpler too, because both teams run the same analysis.
AuditSafe also wraps third-party programs such as Microsoft Excel and Word, GraphPad, MATLAB, Python and R, plus the software that runs your existing instruments. One AuditSafe license can bring all of them under the same audit trail.
Here is a Phoretix 1D western blot quantitation in the compliant version. Every other TotalLab product follows the same steps.
Point the imager's export at AuditSafe and the blot image is under control the moment it is saved. From then on it is versioned and cannot be overwritten.
After logging in with their own account, the analyst opens Phoretix 1D from inside AuditSafe. Only one person can check out a project at a time.
On check-in AuditSafe records who, what, when and the reason, stores a new immutable version and hashes the files.
A reviewer with sign-off permission re-enters their credentials to approve that exact version, or reject it with a comment explaining what needs to change.
Export the report, the original files and the audit trail as PDF for the batch record, an inspector or your LIMS.
Regulated labs send us their user requirement specifications, supplier questionnaires and data integrity checklists before they buy. The requirements below are the ones that appear most often, paraphrased from those documents, with our answer and who is responsible for each one.
| Ref | What your URS says | Clause | How the compliant version meets it | Owner |
|---|---|---|---|---|
| URS-01 | Each user has a unique account. Shared or generic logins are not allowed. | 11.10(d), 11.100(a) | Every person gets a named account. On first login AuditSafe issues a random password the user must replace, so nobody else ever knows it. | AuditSafe |
| URS-02 | Login uses our Active Directory, with our password rules and lockout policy. | 11.300 | Log in with Microsoft Active Directory (LDAP), OpenID, or AuditSafe's own accounts. Domain password, expiry and lockout rules apply automatically, and multi-factor authentication carries through from AD or OpenID. | Shared |
| URS-03 | Analysts, reviewers and administrators have different rights. | 11.10(d), 11.10(g) | Role-based user groups control who can analyze, who can sign off and who can administer the system. Sign-off is a permission you grant per role. | AuditSafe |
| URS-04 | A secure, computer-generated, time-stamped audit trail records who did what, when and why. | 11.10(e), Annex 11 §9 | The audit trail is always on and users cannot edit it. It records logins and failed login attempts, every check-in with user, time and reason, and every sign-off. For Excel workbooks it records the old and new value of each changed cell. | AuditSafe |
| URS-05 | The audit trail can be reviewed and exported for inspection. | 11.10(b), Annex 11 §9 | Audit trails export as PDF, ready for a batch record review or an inspector. | AuditSafe |
| URS-06 | Raw data cannot be altered or deleted, and any change is traceable. | 11.10(a), 11.10(c) | Raw files live in a protected secure folder. Each checked-in version is immutable and hashed, so tampering is detectable. Finalized data cannot be deleted from AuditSafe. | AuditSafe |
| URS-07 | Earlier results can be retrieved and reproduced. | 11.10(b), 11.10(c) | Every check-in is a version. Any earlier version, with the analysis that produced it, can be opened or exported in its original file format. | AuditSafe |
| URS-08 | There is no uncontrolled gap between image capture and analysis. | 11.10(a), ALCOA+ | Set the imager to save straight into AuditSafe, so the raw image is controlled from the moment it exists. The imager's own acquisition settings stay in the imager's records. | Shared |
| URS-09 | Electronic signatures show the signer's name, date, time and meaning, and are linked to the record. | 11.50, 11.70 | A sign-off is bound to one committed version and to the signer's credentials. It cannot be copied to another record, and any later change creates a new version that needs a new sign-off. | AuditSafe |
| URS-10 | Signing requires two components, user ID and password. | 11.200(a) | The signer re-enters their user ID and password at the moment of signing. | AuditSafe |
| URS-11 | Data can be exported to our LIMS or archive in readable form. | 11.10(b), Annex 11 §8 | Reports, original files and audit trails export in their native formats and as PDF. AuditSafe complements a LIMS rather than replacing it, so your LIMS team decides how results are imported. | Shared |
| URS-12 | Records are backed up and can be restored within a defined time. | Annex 11 §7 | All AuditSafe records sit in one secure folder and one SQLite database file, so your existing enterprise backup covers them. Your IT team owns the backup schedule and restore testing; we provide the guidance. | Your IT |
| URS-13 | Users cannot change the system clock, and time stamps are reliable. | 11.10(e) | AuditSafe time-stamps from the host system clock. Lock the clock down and keep it synchronized through your Windows domain policy. | Your IT |
| URS-14 | Inactive sessions lock automatically. | Annex 11 §12 | The inactivity time-out is configurable, so you set it to match your own security policy. | AuditSafe |
| URS-15 | Software updates must not change the validated state without our approval. | Annex 11 §10 | No update is installed unless you choose to install it. Each release comes with signed release notes so QA can assess the change and decide what to re-test. | TotalLab |
| URS-16 | The supplier provides installation and operational qualification documents. | Annex 11 §4 | We supply an IQ/OQ protocol and execute it with you, remotely or on site, with user training included on site. | TotalLab |
| URS-17 | State the GAMP 5 software category. | GAMP 5 | AuditSafe and TotalLab analysis software are configurable off-the-shelf products, which we class as GAMP 5 Category 3. That keeps your validation effort far below a custom-built system. | TotalLab |
| URS-18 | Performance qualification proves the system works for our method. | Annex 11 §4 | PQ runs on your samples and your SOPs, so your team writes and executes it. We support you with method questions during PQ. | Your SOPs |
The full line-by-line mapping of 21 CFR Part 11 (11.10 to 11.300) and EU Annex 11 is in the AuditSafe Regulatory Compliance Guide. Request the guide.
Supplier audits go faster when everyone knows the split up front. This is the split our regulated customers work to.
No. The standard version is built for research labs. Compliance comes from running it inside AuditSafe, which adds the user management, audit trail, version control and electronic signatures that Part 11 and Annex 11 require.
No. Older TotalLab products had separate 21 CFR and GxP editions, such as CLIQS 21 CFR and the TotalLab GxP module. AuditSafe replaced them. You license the standard analysis software plus AuditSafe.
No. AuditSafe controls and records the work; the analysis happens in Phoretix 1D, PlateLogic or whichever program you run inside it.
The analysis software keeps its own license, per computer. AuditSafe is an annual subscription sold in packs of five named users, and it can be installed on as many computers as you need because it tracks people, not machines. Support, training and updates are included. One AuditSafe license covers every program you run inside it.
Yes. Development teams can run the standard version for research work, and QC runs the same analysis inside AuditSafe. Because both use the same release, methods transfer without re-work.
In most cases, yes. AuditSafe launches the instrument's own software and puts every file it saves under version control, audit trail and sign-off. It cannot record values that the instrument software never saves, and it does not add features inside that software.
Those products are no longer supported. Their replacement is Phoretix 1D running inside AuditSafe, which adds current Windows 11 support. Phoretix 1D opens TotalLab Quant, TL120 and TL100 project files, and we will help you plan the comparison runs your QA team needs before switching.
Updates are never pushed to you. You decide when to move to a new release, and each one comes with signed release notes so QA can judge what needs re-testing. Until then you stay on the exact build you validated.
No. AuditSafe runs on your own server and activates completely offline. Let us know at quote stage if the analysis workstations are offline as well, and we will arrange their license activation with your IT team.
You do, with our help. We provide the IQ/OQ protocol and execution, the Regulatory Compliance Guide and a signed response to your URS. Your team owns the URS, risk assessment, PQ and SOPs.
Yes. Send it over and we return it completed and signed, accepting or rejecting each requirement with a comment. We would rather mark a line "not met" than have it fail during your qualification.
Building life science software in Newcastle since 1989, and 21 CFR Part 11 software since 2009. Send your URS or supplier questionnaire and we will return it answered line by line, or book a demo and watch a regulated analysis run end to end.