How our CSV services help you
CSV protocols for all your needs.

Our experience and templates include SolidWorks/SolidWorks PDM, IBM’s Rational ALM applications, MATLAB, Minitab, PTC Integrity, Oracle Agile, and many other common engineering application suites.

Cost savings.

Our clients typically reduce their cost by 30% using our CSV services.

No generic processes.

Our CSV templates were developed by engineers who understand these tools.

Computer System Validation (CSV) Summary

If you develop medical IP, you know the FDA quality system regulations 21 CFR Part 820 well. You also know that compliance often bogs you down for weeks or even months, delaying your application deployments, preventing timely application updates, slowing down product development — potentially making you an alternative solution rather than the industry leader.

What if you didn’t have to start your CSV from scratch? Our consultants are engineers who use the tools and also understand the CSV process. They’ve done this before, hundreds of times. They know what common snags you can run into and can easily adapt to specific issues for your products. That means your CSV process is over in days rather than weeks or months.

Businesses that trust in SPK

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