Meet pharma IT and compliance demands without risking your margins or your sanity

Delivering equipment with inline quality control to pharma can be a daunting task. We're here to help machine manufacturers succeed in a demanding industry.

With decades of pharma and IT experience, we’re the software partner that assists with URS reviews, delivers standardized and fully compliant software products and handles IT/OT integrations so you don’t have to.

Pharma has changed – and the demands wreck your project plan

IT URS documents now run hundreds of requirements deep. NIS2, CRA, and 21 CFR Part 11 compliance are non‑negotiable.

Machine manufacturers are expected to deliver not just automation, but critical data logging, batch report and audit integration, future-ready IT security, and advanced user management.

The consequence? Custom MES integrations and extensive validation exhaust project hours and eat margins long before the machine ships.

Understand URS demands and their implications in detail

We take the lead on analysis of URS and ES requirements relating to IT/MES/SCADA integration, regulatory compliance and critical process barriers.

Then we map out risks and ensure that you know exactly how they impact project calculation and planning.

We also help you uncover what the customer actually needs and challenge any unreasonable demands.

95% of IT URS demands covered by standard products

Our software suite for vision inspection, digital compliance, and data insights is GxP‑ready and covers all the typical IT and regulation-related URS requirements around inspection systems out of the box.

Less development, fewer surprises, easier validation.

We meet pharma’s requirements

With all the necessary certifications and a pre-validated 21 CFR Part 11 compliant software suite we make vendor qualification less of a struggle.

ISO 9001 quality
ISO 14001 environment
ISO 27001 IT security
EcoVadis Gold sustainability rating
21 CFR part 11 compliant software suite
10+ years as a trusted supplier to global pharma

IT integration & regulatory compliance handled by experts

Our standard products log critical data automatically according to pharma standards. And with TRACKS Audit Hub, you can centralize audit trails from PLCs and other systems and devices on the line.

We integrate with enterprise infrastructure and production IT and deliver data to overarching systems in the required formats.

And we support you in meeting regulatory requirements – also NIS2 and CRA.

As a dedicated software partner to pharma machine manufacturers, we create value across your organization

For Sales Teams

Standard calculation tools and a URS-aligned documentation package help sales teams set a competitive budgetary price and respond to a tender without a lot of back and forth. Thorough URS/ES analysis remove uncertainties and help you win pharma projects without betting the margin.

For Project Managers

Our ISO9001 and ISO14001 certified QEMS (quality and environmental management system) lays the foundation for smooth execution focused on early-stage risk mitigation. Data Insights tools speed up commissioning and run-in, reducing time-to-SAT.

For QA Managers

No more piecing together documentation for unfamiliar software products. Our URS-aligned documentation package has everything needed for RFI/RFPs and validation. And with TRACKS Audit Hub, you get instant, audit-ready parameter baselines that streamline FAT/SAT.

For Digital/Automation Leads

You do automation, we do software and integrations. With standard products that meet IT URS demands out of the box and decades of IT experience, we make room for you to focus on what you do best instead of struggling with custom integrations every time.

For Service Managers

Our Data Insights tools for remote line diagnostics mean less downtime and happier customers – without expensive onsite visits. E-learning and training for your customers minimize support requests. Those that do come, we help you handle according to your needs and SLA.

For CEOs

With reduced complexity, standardized platforms, and smoother validation, your team delivers faster and with fewer unknowns. That means predictable margins, less risk, and a stronger competitive position in pharma.