Software Tool Validation, Process Validation and Manufacturing Development
For Medical Device, Biotech Instrument and Pharmaceutical Companies; tools used in the design, development and manufacturing of their shippable products are required to be validated for their intended use. This includes process validation and manufacturing qualification.
Advantu has a long standing reputation for helping our clients achieve success; whether it’s an FDA submittal or audit, MDSAP or CE Certification. Our approach has always been client first, and our goal always aligns with our clients goals because your success is our success – when you win, then we win. It’s perfect synergy.
Which means, per the FDA, impacted companies cannot ship any products until all non-product 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)
Whether it’s mechanical, electromechanical, electronic or software related – Advantu has you covered.
Let’s break this down by Product Development and Manufacturing:
Product Development – Medical Devices/SaMD/Biotech Instruments
Non-Product Software Applications – Intended Use Validation
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.
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.
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, then creating a process for validation, executing, 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
Steve Speers – Quality Systems Manager
“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
What if I don’t have the resources to perform software tool validation 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!
Julie Woolf – COO
“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.’”
Product Development – Mechanical/Electromechanical/Electronic Products
Tools Utilized During Product Development – Intended Use Validation
For companies designing, developing and delivering mechanical, electromechanical and electronic products, there are multiple touch points which require process validation as well as tool validation.
Here are the processes and tools requiring validation: The regulatory agencies require documented evidence that user needs and the product intended use have been met.
In Product Development the path includes comparing and evaluating the input requirements to the final product. This is conducted through a series of tests which include key users that represent the market for which the product was designed, developed and manufactured.
Medical Device Design
Advantu offers comprehensive design and development services from concept to launch – we bring deep expertise in design, development and manufacturing of medical devices, including ISO 13485 design controls and the ability to create a full DHF to support regulatory findings.
- Design Transfer
Qualification of Manufacturing Equipment
- Design and Development Planning
- Human Factors & Usability Engineering
- Proof of Concept
- Prototype Development
- Design Verification
- Packaging Development
- Sterilization Validation
- Model and Drawing Creation
- Supplier selection and evaluation
- Preliminary Risk Evaluation
- Transfer to Manufacturing
- Process Qualifications
- Production Efficiency
- Production Cost Reductions
- Manufacturing Line Transfers
- DMR Transfer
Examples of typical projects:
- Laparoscopic instruments
- Ultrasound (wand/electromechanical instrument)
- Heart Stabilizers
- Single Use Medical Device
- Multi Use Catheter
- Catheter Development
Advantu’s experts have delivered product development and manufacturing support for:
- Johnson & Johnson companies
- Ethicon Inc.
- USGI Medical
- Bariatric Surgery Catheter
- Inovio Pharmaceuticals
- Handheld Oncology Device
Product Development or Machine Qualification Project on the Horizon? Why Wait
If you’re facing the following – let’s schedule a free consultation to discuss your priorities:
- Looming product development project that can’t wait any longer
- Machine qualifications 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.
For a free consultation – simply fill out the form below and hit Submit – we will reach out and schedule your no obligation consult today. 😎