We Can Validate Your Systems For ISO 13485 Certification

Medical device manufacturers are learning that ISO 13485:2016 includes new expectations for computer system validation.

For example, software validation is now expected for Quality Management Systems in addition to the systems used in production, monitoring and measuring equipment. And, validation activities and approaches are now required to be proportionate to associated risks.

We are available to focus exclusively on your project – no distractions – to get the validation done quickly.

And, we use the latest risk-based validation approaches, so you can start using your new system soon.

Get help with your ISO 13485 computer system validation project

They wanted to start using the application for managing SOPs, CAPAs, Complaints and Quality Metrics. However they didn't have any in-house CSV expertise.

Customer Success Story

A US medical device manufacturer had recently purchased and installed a new Quality Management System.

They wanted to start using the application for managing SOPs, CAPAs, Complaints, and Quality Metrics. However, they didn’t have any in-house computer system validation expertise.

So, ProPharma provided the Risk Assessment and CSV SOPs, CSV templates, and the validation experts to quickly validate the new QMS application.

Validate your systems for ISO 13485 certification (Outsourced Validation)

We will ensure that your computer system validation complies with ISO 13485 and with FDA regulations, such as Part 11 and 21 CFR 820.

Our team will:

  • Provide a suite of risk-based Software Validation SOPs and templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report
  • Perform a system Risk Assessment
  • Develop a Validation Plan that is appropriate for the system risk level
  • Work with your team to document User Requirements and Functional Specifications
  • Develop Test Plans and Deliver Validation Protocols (i.e., IQ, OQ, PQ)
  • Execute the Validation Protocols and provide supporting test documentation including a Trace Matrix
  • Deliver an inspection-ready Test Summary and Validation Report

Get Help With Your ISO 13485 Computer System Validation Project

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