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.

Computer System Validation icon

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. 

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Program and project management icon

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. 

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. 

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Medical device icon

Proven 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. 

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Quality & Compliance icon

CSV 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. 

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Compliance

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. 

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. 

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Commissioning, qualification, validation icon

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. 

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. 

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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.

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Health care professionals reviewing computer monitors inside an examination room

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
Microscope with blinding light behind it
Several business professionals working around a conference table

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
Business professionals smiling at a desk reviewing data
Group of professional women talking in a lobby

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 Bio Photo

    Deb Bartel

    Vice President of Quality Assurance

  • Rodrigo Perez Bio Photo

    Rodrigo Perez

    Associate Director, Computer System Validation & Data Integrity

  • John Gow Bio Photo

    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.

News & Insights

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

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ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

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ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

ProPharma Receives 2024 CRO Leadership Award

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ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

Infographic The Cost of Poor Project Management - ProPharma

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Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

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Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Previous Post Arrow Next Post Arrow
ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

Previous Award Arrow Next Award Arrow
ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

PMA Post-Approval Study Considerations

October 7, 2024

PMA Post-Approval Study Considerations

Learn the essential considerations for conducting Post-Approval Studies (PAS) for medical devices, including protocols, timelines, and reporting requirements to ensure compliance with FDA regulations.

What is a Clinical Evaluation Report (CER)?

September 30, 2024

What is a Clinical Evaluation Report (CER)?

Learn the fundamentals of a Clinical Evaluation Report (CER), its evolution under EU MDR, and strategies for ensuring compliance with medical device regulations.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow