Intended use validation of non-product software is required for Medical Device, Biotech and Pharmaceutical Companies. Tools used in the design, development and manufacturing of their shippable products (including tools that automate quality processes) are required to be validated for their intended use.

Advantu has a well-earned record: 100% success rate helping our clients achieve compliance: whether it’s an FDA Submittal, Audit, MDSAP or CE Certification.

Per the FDA, companies cannot ship any products until all non-product software validation (and related documentation) including process validation, is complete, accurate, and fully compliant. Quality leaders for both product development and manufacturing are responsible for meeting these validation requirements.

  • 21 CFR 820.30
  • ISO 13485:2016
  • ISO 9001:2015
  • 21 CFR 820.70(i)

Intended Use Validation of Non-Product Software Applications

The FDA has been cracking down on non-compliance for software applications used in the design, production and manufacturing of medical devices, biotech instruments and pharmaceuticals.  Let us help you determine which software applications require intended use validation (and execute to successful completion for you) if desired.

Intended Use Validation of Non Product Software Applications


Kathryn Nelson – Development Manager


“Advantu quickly and efficiently provided software qualification and technical writing expertise allowing us to successfully reach our quality milestones.”

How do I know which software needs to be validated?

Whether it’s custom built in-house or commercial off-the-shelf software, we can walk you through the process of identifying which software applications require validation, (including level of effort), and how to meet FDA and ISO requirements for compliance.

Most of our clients ask us to perform all the work; if that’s you – we’ll make sure your software tool validation program is accurate, complete, and fully compliant.Make sure your IUV program is up to date and fully compliant

What is Non-Product Software?

Per the FDA:

  • Software used as a component, part, or accessory of a medical device
  • Software that is itself a medical device (e.g., blood establishment software)
  • Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment)
  • Software used for implementation of the device manufacturer’s quality system (e.g., software that records and maintains quality management system records)
  • Software that generates raw data in support of regulatory or validated work
  • Software that requires access control
  • Software that automates any part of the production process, or any part of the quality system
  • Software that creates, modifies, and maintains electronic records

How can Advantu Help?

We begin with identifying which software applications need to be validated for intended use. We continue with creating a process for validation, execution, and correctly documenting it to ensure your organization meets FDA and EU requirements for non-product software validation.

Engage our experienced team to:

  • Work with your team to identify and address gaps in your non-product software validation procedure and templates
  • Conduct an initial impact assessment using Advantu’s proprietary risk analysis methodology to determine if the software tool/system requires intended use validation
  • Develop a validation test plan in accordance with your procedures to provide an overview of the methodologies, intended use and risks for each software tool/system
  • Work with you team to assist in discovering, developing, and grooming user requirements/specifications and overall system risks
  • Develop Installation Qualification (IQ) test cases and execute to validate installation requirements
  • Develop Operational Qualification (OQ) test cases and execute to validate that functional requirements of the system are met for its intended use
  • Develop Performance Qualification (PQ) test cases and execute to validate that user requirements are being met by the system for its intended use
  • Provide software tool/system release notes and provide guidance for change control measures to ensure that only validated systems are in use at all times

IUV accuracy is critical for 510(k) submittals


Steve Speers – Quality Systems Manager

Synthetic Genomics, Inc.

“We wanted to add a new DNA Synthesis Instrument to our GMP workflow, so we brought Advantu’s Process Experts on board to conduct the appropriate analysis, develop the plan and spearhead the implementation.’

‘I wholeheartedly recommend them for any Quality Process support you may need.’”


Examples of Non-Product Software Applications Requiring Validation

If you are developing a drug, building a medical device or biotech instrument – and you utilize any written procedures, hardware, or software application(s) to support the design, development or manufacturing processes for your customer facing product – then they require intended use validation, per FDA 21 CFR 820.70(i)).

Whether you utilize a commercial off the shelf product (such as Excel or any spreadsheet program) or build one yourself (in-house developed software application to capture defects, for example) then, each software application requires its own process for intended use validation.

Commonly Used Applications:

  • Quality Management System
  • Defect Tracking System
  • Document Storage
  • Test Development System
  • Test Harnesses
  • Test Automation System

Frequently Ask IUV Questions

If you have questions regarding the compliance of certain activities, documentation or whether IUV is required (or not) here’s our FAQ List:


What if I don’t have the resources to perform software tool validation (IUV) including documentation?

That’s a great question, and we hear it all the time.  Advantu has supported multiple biotech, biopharma and medical device companies for their IUV needs, and for 95% of them we performed all the work ourselves.  Our clients have enjoyed having their submittals accepted, plus – they’ve passed audits for MDSAP and CE certification.  All due to the skill, experience, and dedication of our Process Experts.  

If you are experiencing a software tool challenge, or you have questions regarding various IUV parameters – let’s hop on a call today!

Intended Use Validation inaccuracies can cause an FDA Audit failureJulie Woolf – COO

The Argen Corporation

“During our preparation for an MDSAP Audit, we reached out to Advantu to conduct a gap analysis for our software validation process to ensure we had everything in place for a successful audit.’

‘Advantu’s thorough assessment and remediation assistance allowed us to ensure Argen was fully prepared and in doing so, enabled us to pass the MDSAP Audit with no software validation findings.’

‘We highly recommend Advantu for any Quality & Software Validation needs.’”

Unsure if your IUV Program is fully compliant? Why Wait…

If you’re facing the following – let’s schedule a free consultation to discuss your priorities:

  • Looming medical device submittal/audit that can’t wait any longer
  • New tools requiring validation that have been put off due to resource/bandwidth issues

Here’s the good news – our experts have been helping teams address and resolve these issues for decades – let’s put our expertise to work for you.

‘Click’ here to Email Felicia in Sales and tell her to schedule your Free IUV Consult today! 😎