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

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-project-management

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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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

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

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. 

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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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commission-qual-validation

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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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.

Hand holding pen between fingers typing on laptop and using tablet device
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

Deb Bartel

Senior Vice President, Quality Assurance

rodrigo-perez

Rodrigo Perez

Associate Director, Computer System Validation & Data Integrity

john-gow

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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Press Releases Awards 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

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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EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

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Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

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