Ensure the success of your software validation project… before you begin. Our consultants can help you implement a proven validation methodology for computer system compliance and prepare your staff to use the latest in computer system validation techniques.
It can take months to investigate the regulations, benchmark with other companies, and design your own SOPs and templates for software quality. This can significantly detract your personnel from their primary responsibilities.
Instead, our CSV and SQA experts can work with you to quickly implement and deploy a software quality and validation program that’s on par with your most experienced competitors. You can start validating your systems in a matter of weeks.
Our Approach to Implementing a Compliant CSV Program
We apply the following approach to implementing a computer system validation program that complies with FDA regulations, EU regulatory expectations, and industry best practices:
- Supply a standard suite of Software Quality Assurance SOPs, such as Risk-Based Validation, System Change Control, Incident Management, and Internal Audits
- Adapt the standard SOPs to integrate with your existing SDLC, QMS, and technologies
- Provide a standard suite of Software Validation Templates, such as the Validation Plan, User Requirements, Test Protocols, and the Validation Report
- Educate your staff in the use of the Software Quality Assurance SOPs and Validation Templates
- Deliver ongoing support throughout your first validation project
Realize Results with an Effective CSV Program
- Dramatically shortened timeline for developing your computer system validation methodology and software quality assurance processes
- Confidence that your validation approach meets industry standards and will withstand the scrutiny of regulatory inspectors and customer audits
- Reassurance that your staff has been educated in best practices and is capable of successfully validating your systems