A plug-and-play compliance middleware that instantly adds electronic signatures, secure audit trails, and Active Directory integration to your commercial lab equipment.
If you manufacture laboratory hardware or software, you already know that selling into GMP-regulated environments requires strict adherence to FDA 21 CFR Part 11 and EU Annex 11.
But building these compliance features from scratch is a massive drain on your resources. It forces your engineering team to spend 18-24 months building security layers, user access controls, and audit trails instead of innovating on your core technology.
AuditSafe is your shortcut. By integrating our proven compliance middleware, you can instantly upgrade your product line, qualify for enterprise pharma bids, and get to market faster.
When World Precision Instruments (WPI), a global manufacturer with over 55 years in the life sciences market, needed to bring their EVOM Auto product line into pharmaceutical and contract research markets, they chose AuditSafe over building 21 CFR Part 11 compliance in-house. WPI launched the compliant EVOM Auto at the MPS World Summit in 2024, opening the pharma and CRO segment for the EVOM family.
WPI’s selection came down to three things:
“We are laser focused on developing and advancing technology that meets the rigorous compliance needs of our partners, including pharmaceutical laboratories and contract research organizations.” Dr. Adrienne Watson, Chief Scientific Officer, World Precision Instruments
| Strategic Factor | Building Compliance In-House (The Old Way) | Using AuditSafe (The Smart Way) |
| Time to Market | 18 – 24 Months. Severe delays to your product launch roadmap. | Weeks. Plug-and-play middleware gets you selling immediately. |
| Development Cost | High & Unpredictable. Requires a dedicated team of specialized security developers. | Predictable ROI. Flexible licensing models scaled to your sales volume. |
| Regulatory Validation | High Risk. You have to build, test, and validate complex ALCOA+ features from scratch. | Zero Risk. A proven, industry-tested solution already trusted by regulated labs globally. |
| Ongoing Maintenance | Resource Drain. Your engineers are stuck updating compliance patches forever instead of innovating. | Managed for You. TotalLab handles all software updates and shifting regulatory requirements. |
| Core Business Focus | Distracted. Your team is focused on IT security and Active Directory integration. | Focused. Your team focuses 100% on what you do best: scientific hardware and analysis. |
When you integrate AuditSafe, your instruments instantly inherit:
These are four of the nine controls GMP compliant software must provide; the full list is in our guide to what GMP compliant software means.
Let’s talk integration. Fill out the form below, and our OEM Partnerships Director will be in touch within 1 business day to schedule a technical discovery call. We’ll discuss your specific instrument architecture and map out the fastest path to compliance.
How software partnerships work for instrument makers: the three commercial models compared, integration options, compliance editions that open the regulated market, IP and branding, modernizing legacy software, and what an engagement looks like.
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No regulator certifies software as GMP compliant. The nine controls the phrase should mean, what 21 CFR Part 11 and Annex 11 require, ten checks to run on any vendor's claim, and three routes to making existing software compliant.
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The two regulations compared section by section: scope, audit trails, electronic signatures, validation and suppliers, where each goes further, the 2025 draft revision of Annex 11 and new Annex 22, and how one system satisfies both markets.
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