Computer System Validation (CSV)
Develop and execute computer system validations in a fraction of the time and for a fraction of the cost.
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!
Our Computer System Validation (CSV) Services
Learn more about our Computer System Validation (CSV) services through this case study.
Why Teams Choose SPK and Associates
SPK and associates is the engineering-focused partner trusted to optimize, connect, and modernize complex systems across the entire product development lifecycle.
Engineering-Focused Modernization
We modernize engineering environments by connecting the tools and data that power the entire product lifecycle across engineering and IT. We leverage automation, analytics, and AI to deliver smarter outcomes.
✓ ALM, PLM, CAD, DevOps, QMS
✓ Data, Analytics, and AI experts
✓ Real-world product expertise
Long-Term Partnerships
On average, clients choose to work with SPK for 8+ years. Our team is an extension of your team that focuses on your business outcomes. This approach builds deep knowledge of your people, processes, and technology to drive better outcomes.
✓ Trusted advisor approach
✓ Reliable, responsive experts
✓ Deep domain experience
✓ 23 year proven track record
Extensive Regulatory Experience
Our team has 20+ years of experience helping companies in highly regulated industries confidently meet compliance and quality standards. We save your engineers' time, so instead of filling out audits, your teams can innovate.
✓ Medical Device (FDA, ISO 13485)
✓ Aerospace (DO-178C, ITAR)
✓ Automotive (ISO 26262, R155/R156)
✓ Energy, Industrial & More
Outcomes-based Approach
SPK's ACEs approach accelerates product delivery while improving compliance, quality, and cost-efficiency. Our team provides strategic guidance and hands-on support focused on your business outcomes.
✓ Accelerated time to market
✓ Cost efficiency & cost reduction
✓ Ensured Compliance
✓ Exceptional Quality
23+
Years of Experience
300+
Global Clients
8+ Years
Average client relationship
Certified
Woman-owned business
TRUSTED PARTNERS
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
- 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
Related Medical Device Resources
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