Computer System Validation

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Tailored Qualification Services for Your Automated Systems

Reliance on advanced technologies is more critical than ever. At ProPharma Group, we apply proven methodologies based on industry regulations to help clients implement best practices and meet validation needs.

With our collective industry and regulatory knowledge, our teams offer tailored services for Computer System Validation to deliver the outcomes your company needs to be successful in computerized system lifecycle management.

Multi-Disciplinary Approach

Our experts use a multi-disciplinary approach that goes beyond validation to mitigate potential gaps before they lead to a regulatory warning, regardless of the issuing agency (FDA, Health Canada, EMA, etc.). Our industry-leading team of consultants stay informed on the latest technologies and methodologies through field and in-house experience as well as ongoing industry training.

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Looking to Maintain Quality and Compliance for Your Product?

Contact us to learn how our team of specialists can ensure quality and regulatory requirements are met throughout your product’s lifecycle to successfully bring your product to market.

Interested in gaining an industry edge? Let us help you stay current.

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Overview

FDA Services: Drug Development

EMA/National Agencies Services: Pre-Authorization

EMA/National Agencies Services: Post-Authorization

US & EU: Medical Device Development

EMA/National Agencies Services: Regulatory Operations

Overview

Compliance

Product and Process Lifecycle Management

Commissioning, Qualification, and Validation

Engineering and Project Management

Clinical Consulting

Specialized Services

Overview

Clinical PV

Postmarketing PV

Overview

Global Medical Information Contact Centers

Medical Writing and Content Management

Other MI Services

Tailored Qualification Services for Your Automated Systems

Multi-Disciplinary Approach

Related Services

EVENTS

December 14-15

December 14-15

Looking to Maintain Quality and Compliance for Your Product?

Gain an Industry Edge With Expertise From ProPharma Group