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