Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

What is validation and why is it perceived as so complex?

December 8, 2016 By Danielle Kirsh

Oscar Ford/Business Development Manager/Preh IMA Automation Evansville Inc.

validationMany perceive validation as complex, ill-defined, and fear-inducing. The question is, “Why?” Why does the mere mention of the word “validation” stimulate fear and anxiety for some people? The following might provide some insight into this perception: 

In many cases validation is not consistently described and understood because it depends on the interpretation of the person or entity considering the word. In other words, what validation means to one person (whether that person is a validation engineer, manufacturing engineer, quality engineer or someone else), can vary significantly based on that person’s interpretation of the guidelines. This inconsistency can certainly contribute to the perception of complexity; we can all relate to a task becoming more complex and more difficult to accomplish when it feels like you are “aiming at moving target.”

Another issue is that the word validation is frequently used indiscriminately. For example, validation is used in reference to something that is probably better classified as testing or qualification, such as machine or equipment qualification. At other times it’s used when referencing process validation (which is typically achieved by conducting an IQ/Installation Qualification, OQ/Operational Qualification and PQ/Performance Qualification); that is, if you don’t subscribe to process capability and control mode (P&PC) methods. It is sometimes used in reference to software validation; in fact, you can probably think of several additional activities implied when the word “validation” is used. 

Although this as the state of things regarding validation and the perception of complexity, from a medical device manufacturer, contract manufacturer,or another healthcare companies’ perspective, what should these manufacturers expect from their suppliers related to validation?

The answer:  Your supplier should be able to specifically address how they will assist you with validation activities by sharing their expertise, experience, and validation processes.

Here are a few tips on how to make sure the automation company that builds your automated assembly system has the capability and ultimately delivers value for your validation needs:

  • Interview the company specifically related to validation capability, or deploy your company’s vendor or supplier evaluation or management program, up to and including audits when capable.
  • Understand how the company operates in accordance with validation requirements. The company should be able to demonstrate this with tangible examples of standard procedures, deliverable documentation and artifacts, as well as past customer examples. This should require more than “acronym alphabet soup” in which acronyms such as IQ/OQ/PQ, QSR, CFR 21, IAT/FAT/SAT, and GAMP are thrown around without the company demonstrating a real understanding of your validation needs.
  • Understand the company’s level of sophistication and infrastructure related to validation and qualification documentation.

Device manufacturers, contract manufacturers, and other healthcare manufacturing companies should take precautions by rigorously checking potential automation company’s procedures, deliverables, sophistication, infrastructure, experience, and all around validation capability

Related Articles Read More >

Product testing and evaluation at Element Materials Technology
Top tips and tricks for feasibility testing
FDA’s $8.4B budget request includes supply chain, pandemic prep and cancer funding
FlawSense sensor LaserLinc
LaserLinc launches high speed, online inspection and measurement system
Von Mises stress (Mpa)
How to speed through the 60601 drop test with finite element analysis

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech