How World Precision Instruments Chose TotalLab AuditSafe to Bring 21 CFR Part 11 Compliance to the EVOM Product Line
Case study | OEM partnership | Originally announced March 2024
When World Precision Instruments (WPI), a global manufacturer with over 55 years in the life sciences market, set out to make their EVOM Auto product line ready for pharmaceutical and regulated environments, they needed a software partner who could deliver 21 CFR Part 11 and GMP compliance without forcing them to build a regulatory software team from scratch. They chose TotalLab AuditSafe.
This partnership is now powering EVOM Auto deployments in pharmaceutical laboratories, contract research organisations (CROs), and preclinical research facilities where audit-ready electronic records, electronic signatures, and full data integrity are non-negotiable.
The Challenge: Getting Hardware Into Regulated Markets
For instrument manufacturers, the opportunity in pharma and biotech is significant, but the regulatory bar is high. FDA 21 CFR Part 11 and GMP requirements demand:
- Tamper-evident audit trails on every data action
- Secure electronic signatures linked to authenticated users
- Robust user access controls and role separation
- Validated, version-controlled software with a documented quality system
- Data integrity protections meeting ALCOA+ principles
Most equipment manufacturers face a choice: spend years (and millions) building this in-house, or find a specialist partner. WPI took the partner route, and after evaluating the market, selected TotalLab.
Why WPI Selected TotalLab AuditSafe
“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. Our commitment to innovation and excellence drives us to deliver solutions that empower researchers and scientific professionals to navigate regulatory challenges with confidence and accuracy.”
Dr. Adrienne Watson, Chief Scientific Officer, World Precision Instruments
Three factors drove the selection:
1. AuditSafe is purpose-built as an OEM overlay
AuditSafe was designed specifically to add 21 CFR Part 11 and GMP capabilities to existing instrument software, without requiring the OEM to re-engineer their core product. This lets manufacturers like WPI bring compliance-ready versions of their instruments to market in months, not years.
2. Over 20 years of life science software experience
TotalLab has been writing analysis and compliance software for the life science industry for more than two decades, with customers across pharma, biotech, and the world’s leading instrument manufacturers. That track record matters when an OEM is staking its regulated-market reputation on a partner.
3. A genuine partnership model, not a licence-and-leave vendor
TotalLab’s OEM development service works alongside the manufacturer’s engineering team through integration, validation support, and lifecycle maintenance. WPI got a partner who stays with them, not a contract that ends at handover.
What AuditSafe Delivers to the EVOM Product Line
The AuditSafe integration gives EVOM Auto users:
- Full FDA 21 CFR Part 11 electronic records and electronic signatures
- Audit trails capturing every user action, with timestamps and reasons-for-change
- Role-based access control with configurable permissions
- Data integrity controls aligned to ALCOA+ and GxP requirements
- Validated software backed by TotalLab’s documented quality management system
For pharma and CRO customers running TEER measurements, organ-on-chip studies, drug development workflows, and preclinical research, this means data from EVOM Auto can flow directly into regulated workflows without separate compliance overhead.
The Outcome
WPI launched the 21 CFR Part 11 compliant EVOM Auto at the Microphysiological Systems (MPS) World Summit in Seattle in June 2024, opening up a previously inaccessible segment of the pharmaceutical and CRO market for the EVOM family. The partnership continues to support new compliant releases across WPI’s instrument range.
For Other Equipment Manufacturers Considering 21 CFR Part 11
If you are an instrument or device manufacturer evaluating how to bring your products into regulated pharma, biotech, or clinical workflows, the WPI partnership is a template that works.
TotalLab works with OEMs on:
- 21 CFR Part 11 and GMP overlay integration via AuditSafe
- Bespoke 21 CFR Part 11 database development
- Custom life science software development including AI-powered features
- Long-term software maintenance and validation support
Ready to take your instrument into regulated markets? Talk to TotalLab about your OEM project or learn more about AuditSafe for OEMs.
Frequently Asked Questions
What is TotalLab AuditSafe?
AuditSafe is TotalLab’s 21 CFR Part 11 and GMP compliance software, designed as an overlay that adds regulatory-grade audit trails, electronic signatures, user access control, and data integrity protections to existing instrument software. It is used by equipment manufacturers to make their products ready for pharmaceutical, biotech, and clinical deployments.
Why did World Precision Instruments choose TotalLab?
WPI selected TotalLab because AuditSafe is purpose-built for OEM integration, TotalLab has over 20 years of life science software experience, and the partnership model gave WPI ongoing engineering support rather than a one-off licence. The integration enabled WPI to bring the EVOM Auto into pharmaceutical and CRO markets that require 21 CFR Part 11 compliance.
Can other OEMs use AuditSafe?
Yes. AuditSafe is available to instrument and equipment manufacturers across the life sciences. TotalLab works with each OEM partner on integration, validation, and long-term support. Contact TotalLab to discuss your product line.
What does 21 CFR Part 11 compliance require?
21 CFR Part 11 is the FDA regulation covering electronic records and electronic signatures in regulated industries. Compliant systems must provide tamper-evident audit trails, authenticated electronic signatures linked to user identities, robust access controls, and validated software with documented controls protecting data integrity.
How long does an OEM integration typically take?
Timelines vary by product complexity, but TotalLab’s AuditSafe overlay approach is designed to be measured in months rather than years, because the OEM does not have to build the compliance engine from scratch. Reach out for a scoping conversation.
Read the Original Announcement
The full announcement of the WPI / TotalLab partnership was issued via PR Newswire on 20 March 2024: World Precision Instruments Partners with TotalLab to Introduce 21 CFR Part 11 into the EVOM Product Line.
Considering AuditSafe for your instrument range? Book a discovery call with the TotalLab team.