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.
Standard Validation Templates
We provide a standard suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report.
Proven Validation Methodology
Our experts provide custom, risk-based validation approaches to meeting FDA, EMA, MHRA, and other agency expectations.
CSV and CSA Expertise
Experienced software validation managers and engineers who can get your validation project finished on time.
Inspection-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.
Education & 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.
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.
CSV Training & Resources
Access essential training and resources for computer system validation, compliance, and data integrity at Validation Center, ProPharma knowledge center and resource.
Attend free webinars, enroll in online and in-person classes in the US and Europe, and download valuable templates and standard operating procedures. Validation Center offers everything you need for CSV and software quality assurance.
Meet Our CSV and CSA Experts & Consultants
-
Deb Bartel
Vice President of Quality Assurance
-
Rodrigo Perez
Associate Director, Computer System Validation & Data Integrity
-
John Gow
Senior Consultant
News & Insights
July 28, 2025
Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market
Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...
July 25, 2025
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).
July 24, 2025
FDA Publishes over 200 Complete Response Letters (CRLs)
FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.
.png?width=320&height=185&name=Obesity%20%E2%80%93%20Accelerated%20Timelines%20(1).png)
.png?width=320&height=185&name=labeling-webinar-thumbnail%20(1).png)
News & Insights
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
