computer system validation (CSV)
Custom risk-based validation approaches to meet FDA, EMA, MHRA and other agency expectations.
Validation Services for Pharmaceutical, Biotech, Medical Device, Clinical Research, and Software Industries.
FDA, EMA, MHRA Compliant
ProPharma will ensure that your validation complies with FDA, EMA, MHRA, and other agency regulations.
FDA, EMA, MHRA Compliant
ProPharma will ensure that your validation complies with FDA, EMA, MHRA, and other agency regulations.
Read LessStandard Validation Templates
We provide a standard suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report.
Read MoreStandard Validation Templates
We provide a standard suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report.
Read LessProven Validation Methodology
Our experts provide custom, risk-based validation approaches to meeting FDA, EMA, MHRA, and other agency expectations.
Proven Validation Methodology
Our experts provide custom, risk-based validation approaches to meeting FDA, EMA, MHRA, and other agency expectations.
Read LessCSV and CSA Expertise
Experienced software validation managers and engineers who can get your validation project finished on time.
CSV and CSA Expertise
Experienced software validation managers and engineers who can get your validation project finished on time.
Read LessInspection-Ready Documentation
We give clients the confidence that the validation deliverables meet industry standards and will withstand the scrutiny of customer audits and regulatory inspections.
Read MoreInspection-Ready Documentation
We give clients the confidence that the validation deliverables meet industry standards and will withstand the scrutiny of customer audits and regulatory inspections.
Read LessEducation & Ongoing Support
We will educate your staff in the use of Software Quality Assurance SOPs and Validation Templates, and deliver ongoing support throughout your validation project.
Read MoreEducation & Ongoing Support
We will educate your staff in the use of Software Quality Assurance SOPs and Validation Templates, and deliver ongoing support throughout your validation project.
Read LessComputer 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.
Meet Our CSA and CSA Experts & Consultants
Deb Bartel
Senior Vice President, Quality Assurance
Rodrigo Perez
Associate Director, Computer System Validation & Data Integrity
John Gow
Senior Consultant
Bespoke Approach. Proven Results.
ProPharma provides custom, risk-based computer system validation services to meet regulatory agency expectations that ensure compliance, reduce timelines, and deliver inspection-ready documentation. Outsource your validation project to ProPharma's experts for efficient and effective validation solutions.
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RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
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Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
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Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
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ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
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