Computer System Validation (CSV)

Computer System Validation Services

ProPharma has experienced software validation managers and engineers who can get your validation project finished on time. Our validation experts focus exclusively on your project – no distractions – to get the validation done quickly by using the latest risk-based validation approaches (e.g., CSA). Or, if your organization has a legacy system that needs retrospective validation, ProPharma’s experts can promptly remediate the situation, so you don’t get caught in a state of non-compliance.

By outsourcing your next Validation Project, or your entire Validation Program, to ProPharma, your organization can:

• Significantly reduce the timeline to a 'validated state'; ProPharma bring the methodology, templates, and trained validation professionals
• Have the confidence that your validation documentation is inspection-ready
• Utilize your employees’ time to focus on what they do best, rather than struggling with CSV or CSA.

ProPharma will ensure that your validation complies with FDA, EMA, MHRA, and other agency regulations by:

• Providing a standard suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report
• Documenting a System Risk Assessment
• Developing a Validation Plan that is appropriate for the system risk level
• Working with your team to document User Requirements and Functional Specifications
• Developing Test Plans and Delivering Validation Protocols (i.e., IQ, OQ, PQ)
• Executing the Validation Protocols and providing supporting test documentation
• Delivering an inspection-ready Test Summary and Validation Report

CSV and CSA Programs

ProPharma’s consultants can help you implement a proven validation methodology for computer system compliance and prepare your staff to use the latest computer system validation (CSV) and computer software assurance (CSA) techniques. Our experts can work with you to deploy a program that’s on par with your most experienced competitors. You can start validating your systems in a matter of weeks.

With ProPharma’s help, your organization can have:

• A dramatically shortened timeline for developing computer system validation and software quality assurance processes
• Confidence that the validation approach meets industry standards and will withstand the scrutiny of customer audits and regulatory inspections
• Reassurance that personnel have been educated in best practices and are capable of successfully validating your systems

ProPharma applies the following approach to implementing CSV and CSA programs that comply with FDA regulations, EU regulatory expectations, and industry best practices:

• Provide 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 documentation systems
• Provide a standard suite of Software Validation Templates, such as the Validation Plan, Risk Assessment, 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.