Achieve 21 CFR Part 11 & GMP Compliance Across Your Entire Lab | AuditSafe

A universal, vendor-neutral compliance overlay that secures your data, enforces electronic signatures, and retrofits your existing equipment for regulatory audits.

TotalLab’s 21 CFR Part 11/GMP-compliant software is trusted by some of the world’s leading pharmaceutical companies and medical institutions:

How Does AuditSafe Work?

Think of AuditSafe as a software layer or wrapper that once logged into, provides tracked access to any software or equipment that sits within it. AuditSafe provides all the required tools and infrastructure to achieve 21 CFR Part 11/GMP-compliance – audit trails, user authentication, configurable permission levels for users, secure file storage etc. As long as the data stays within AuditSafe (passing data between different pieces of integrated software is fine) AuditSafe can track it and generate an audit trail for it.

Projects within AuditSafe can start with data already gathered elsewhere or it can import data directly from almost any piece of lab equipment capable of exporting data – no restrictions on file type. This latter option allows the closure of an extremely common compliance gap within the industry – between data acquisition and analysis.

Why Choose AuditSafe?

Here at TotalLab, we’ve been collaborating with the largest members of the global pharmaceutical industry for over a decade to create a world-leading 21 CFR/GMP-compliant software solution, working with their internal QC/QA department’s User Requirement Specifications (URS) to meet and typically exceed their own stringent internal requirements for compliance, going above that outlined in the actual legislation.

AuditSafe, as a universal piece of 21 CFR/GMP-compliant software, has several advantages over the “old” model of buying a different, individual copy of 21 CFR/GMP-compliant software from a manufacturer every time you need to add a new piece of equipment to your QA/QC lab:

• Single, harmonized 21 CFR/GMP-Compliant workflow – lower training burden, lower risk of inter-operator error. Why train your staff to use multiple, difficult-to-use compliance systems that don’t “speak” to each other when they can just be trained in one?
• No more gaps in compliance – AuditSafe takes raw data directly from equipment and can integrate data between different systems or different manufacturers’ software packages.
• Larger choice of equipment – No longer are departments purchase decisions restricted, AuditSafe can adapt nearly any piece of equipment to make it 21 CFR/GMP-compliant, empowering lab users to choose the right tool for the job.
• Save money by adapting existing equipment – AuditSafe allows labs to adapt legacy equipment that may still have a long lifespan or may be the preferred option for lab users to be 21 CFR/GMP-compliant, even if the original manufacturer never supported regulated use.
• Your files stay yours – AuditSafe doesn’t change or convert your file types locking you into using our software; you can always export your original raw or processed data in the original file type to be opened by other software solutions.

Protect Your Data Integrity Without Replacing Your Hardware

Moving an analytical method from R&D into a tightly regulated GMP environment usually comes with a massive price tag: replacing perfectly good equipment just because the original software lacks 21 CFR Part 11/GMP-compliance. AuditSafe changes the equation.

Designed as a secure, vendor-neutral compliance overlay, AuditSafe sits seamlessly alongside your existing systems. It acts as a data control layer, instantly adding the user access controls, electronic signatures, and secure audit trails required by the FDA and EU Annex 11.

Whether you need to secure your existing TotalLab analysis software or retrofit a mixed fleet of third-party instruments and software (Microsoft Excel, GraphPad Prism, JMP etc.), AuditSafe ensures your data meets strict ALCOA+ principles.

Seamless Compliance for Existing TotalLab Software

Already using another of TotalLab’s analysis packages? AuditSafe is the official  21 CFR Part 11/GMP-compliance companion for the TotalLab ecosystem.

• Native Integration: Works flawlessly with your existing TotalLab software licenses.
• Zero Workflow Disruption: Your scientists continue analyzing gels and blots exactly as they always have, while AuditSafe quietly secures the data in the background.
• Audit-Ready Reports: Generate comprehensive, time-stamped audit trails of every image edit, analysis change, and final result export.

Retrofit Your Third-Party Lab Equipment

You shouldn’t have to buy a new spectrometer or plate reader just to pass an audit. AuditSafe is completely vendor-neutral, meaning it can secure almost any PC-based laboratory instrument.

• Save Your Capital Budget: Carry your trusted R&D equipment directly into GMP-regulated spaces.
• Standardize Your Lab: Instead of learning five different compliance software systems from five different manufacturers, train your staff on one universal compliance overlay.
• Secure Raw Data: Prevent the deletion, overwriting, or undetected modification of raw data files generated by non-compliant hardware.

Everything You Need to Pass Your Next Audit

• Strict User Access Controls: Role-based permissions integrated with your Windows Active Directory to prevent unauthorized system access.
• Comprehensive Audit Trails: Automatic, secure, and time-stamped recording of all user actions (who, what, when, and why).
• Electronic Signatures: Compliant sign-offs for data review and approval, tied directly to the individual user’s credentials.
• Version Control & Archiving: Protects original raw data from alteration while tracking every subsequent version of the analysis.

Are you an instrument manufacturer?

Stop losing bids to regulated labs. Integrate AuditSafe directly into your commercial hardware to unlock GMP markets instantly. Explore OEM Partnerships

Flexible Licensing Options

Here at TotalLab we’ve been working with pharmaceutical customers for decades and we know that some of our users prefer using air-gapped computers to enhance security within their sites. This isn’t a problem, all TotalLab software can be activated easily either online or offline.

Our licensing system licenses number of users, not a specific computer. This means that you can install the AuditSafe software all over your site to have access to your data without having to purchase additional licenses; as long as your number of active users remains the same.

We can also support enterprise licensing for full site-wide licenses covering large pharmaceutical manufacturing facilities and research facilities at a significant discount vs buying singular or multiple licenses.

For pricing and any other licensing related queries please contact us.

Full IQ/OQ Validation Packages Available

At TotalLab, we’ve been supporting the world’s largest pharmaceutical companies with highly secure, production-ready versions of our software for over a decade now and enjoy very good relationships across the industry.

We know the importance of properly validated software and how it forms part of your QC journey so we offer a full, in-person IQ/OQ package to accompany the sale of regulated versions of our software

Frequently Asked Questions About 21 CFR Part 11 Wrapper Software

Can non-compliant lab equipment be made 21 CFR Part 11 compliant? Yes. Instead of replacing expensive hardware when moving from R&D to a GMP environment, you can use a “wrapper” software like AuditSafe. It acts as a secure IT layer over your existing system, adding required features like electronic signatures, user access controls, and secure audit trails without altering the original instrument’s core software.

Does AuditSafe work with instruments from any manufacturer? Yes, AuditSafe is completely vendor-neutral. It is designed to work alongside virtually any PC-based laboratory instrument or analysis software. This allows lab managers to standardize compliance across a mixed fleet of equipment from different OEMs using a single, unified system.

How does a compliance wrapper protect data integrity? A wrapper system secures the operating environment around the instrument. It restricts unauthorized system access, quietly records all user actions in a time-stamped, secure audit trail, and prevents the deletion or undetected modification of raw data files. This ensures your data meets strict ALCOA+ principles for regulatory audits.

Can OEMs integrate AuditSafe into their own commercial devices? Absolutely. OEMs and equipment manufacturers can utilize AuditSafe as a plug-and-play compliance add-on. This allows hardware companies to immediately sell their R&D-focused instruments into heavily regulated pharma and biotech markets without the massive cost, risk, and time delay of building compliant software from scratch.

Will adding AuditSafe disrupt our scientists’ daily workflows? The impact on daily operations is minimal. Scientists continue to use the original equipment software to perform their actual analysis just as they always have. The AuditSafe wrapper simply requires a secure log-in upfront and prompts for electronic signatures when necessary, working quietly and securely in the background.

Ready to Bring Your Lab Equipment into GMP Compliance?

Don’t let non-compliant hardware force you into expensive, unnecessary upgrades. AuditSafe’s compliance overlay can secure your raw data, enforce ALCOA+ principles, and get your lab audit-ready in a fraction of the time and cost.

Schedule a personalized, 30-minute walkthrough with a TotalLab compliance expert to:

• Discuss the specific instruments or TotalLab software you need to secure.
• See a live demonstration of AuditSafe’s electronic signatures and audit trails in action.
• Get a clear roadmap for deploying AuditSafe without disrupting your scientists’ workflows.

Request a Lab Demo

Are you an instrument manufacturer? Stop losing bids to regulated labs. [Explore AuditSafe OEM Integration here.]

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