Business Process Computer Systems Validation (CSV)

Business Process Computer Systems Validation (CSV)

Do you need computer system validation? Does your business have a paper based request or reporting system? Do you use spreadsheets to calculate and/or report results? Does your company want to use a cloud-based approach? 

If any of the answers above are yes, then yes you need CSV!

In a world becoming increasingly reliant on computer systems for generating, reporting, storing and transmitting information, the need for CSV has never been more important. Cheshire Scientific Services only validate systems to the current 21 CFR Part 820, 21CFR Part 11/ EU Annex 11 & GAMP5 standards , providing any of the below requirements for your laboratory:

  1. Software Validation Protocol 
  2. System/Software Requirements Specification
  3. Network Diagram
  4. Risk Analysis and 21CFR Part 11/EU annex 11 compliance analysis
  5. Design & Functional Specification
  6. Full validation protocol generation, execution or review 
  7. Requirements Traceability Matrix


Cheshire Scientific Services can provide a tailored validation approach for your chosen electronic solution no matter the GAMP category

If you need an electronic upgrade for your business process, allow one of our specialists to guide you through from start to finish on how to make a seamless transfer from your current way of working to an easier, reliable, electronically compliant solution.


**Why Choose Our CSV Services?**


1. **Comprehensive Validation Process**: We offer a thorough and systematic approach to CSV, covering all stages from planning and specification to testing and documentation. Our process ensures that your systems perform consistently and meet all regulatory requirements.


2. **Regulatory Expertise**: Our team of seasoned professionals brings extensive experience in navigating complex regulatory landscapes, including FDA, EMA, and other global standards. We ensure your systems are compliant with 21 CFR Part 11, GAMP 5, and other critical guidelines.


3. **Tailored Solutions**: We understand that every business is unique. Our CSV services are customized to meet your specific needs, whether you're implementing new systems or validating existing ones. We work closely with you to develop a validation strategy that aligns with your operational goals.


4. **Risk Mitigation**: By validating your computer systems, we help you mitigate risks associated with data breaches, system failures, and non-compliance. This proactive approach safeguards your operations and enhances patient safety.


5. **Continuous Improvement**: Our commitment to excellence doesn't end with validation. We provide ongoing support and continuous improvement strategies to ensure your systems remain compliant and efficient over time.


**Partner with Us for Reliable and Compliant Systems**


Investing in our CSV services means investing in the reliability and success of your pharmaceutical operations. Let us help you streamline your processes, reduce risks, and achieve regulatory compliance with confidence. Contact us today to learn more about how our expert CSV services can benefit your business.