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Computer System Validation (CSV)

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.

Need help with validation/verification? Our experts can help!

What makes SPK and Associates different?

Customer Loyalty

On average, clients work with SPK and Associates for 8+ years

Regulated Industries

20+ Years of experience with medical device, aerospace, automotive and other regulated industries

Hardware + Software

Uniquely positioned with years of understanding of both hardware and software product development

Companies that Trust SPK and Associates

SPK’s CSV Services

CSV Protocols

Our experience and templates include SolidWorks/SolidWorks PDM, IBM’s Rational ALM applications, MATLAB, Minitab, PTC Windchill RV&S (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.  Because of this, our services are the key to FDA and other organization’s approval.

Our Regulatory Compliance Process

Performing a CSV for our clients includes these general activities:
  • Development Environment Systems and Network Setup in AWS, Azure, or client infrastructure
  • Project Plan Setup
  • Document: Defined Functional Requirements
  • Document: Risk Assessment
  • Document: RACI
  • Setup QA environment in AWS, Azure, or client infrastructure
  • Design Review and Verification
  • Modification of Existing ISO13485 / 21CFR820 Quality Manual – Determine if this needs to be written from scratch
  • Computer System Validation
  • Document: IQ/OQ/PQ Test Script
  • Document: IQ/OQ/PQ Test Report
  • Document: Validation Summary Report
  • Migrate to Production Environment
  • Launch activity:  Admin Training
  • Launch activity: Internal communication
  • Launch activity: Post “go live” briefing to leadership

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