Let’s take a look at GAMP® 5.
The AAMI Technical Information Report (AAMI TIR36:2007) is a standard that covers the validation of software for regulated processes. TIR36 focuses on the machines, software, and processes involved with manufacturing devices and other products. Medical device engineer David A. Vogel lays out strategies for medical device companies in their automated process software validations, and includes a bit of history of multiple standards like TIR36, in Medical Device Software Verification, Validation and Compliance. He has first-hand experience with the standard as he and 13 other specialists in the field worked for about 3 years to establish TIR36, which is structured around the idea that there are multiple tools and approaches available, but only the ones that apply to each software element and its intended use should be used for validations. “The problem of validating non-device software is that it is so broadly defined that no single method or tool will work for all circumstances,” he says. This group published examples of validation plans to show how their methods could be applied, so now they have established some guidance.
Verification & Validation (V&V) is a necessary step in every type of product development. Verification is a process of evaluating the development lifecycle to check if a team is on the right track of creating the final product. Validation is the process of evaluating the final product to check whether the software meets the business needs. Are we making the right product & Did we make the right product = V&V
Some customers coming to Cognition are confused by the guidelines surrounding verification and validation (V&V) work, or they say it was too difficult or time-consuming back when they started a particular project because of the methods or tools (or lack thereof) they had. They show us their 483 citations or are in need of heavy remediation, situations they could have avoided if validation was addressed from the start. Those situations can be really expensive. “Remediation costs represent 0.4 to 0.7 percent of annual sales” in medical devices, according to McKinsey & Company. With their estimate of annual sales of $380 billion, that adds up to $1.5-2.6 billion a year across the medical device industry.
Good, efficient V&V work can be easier if the project is built well: not the product itself, but the structure of data collected about the product. A myriad of elements are involved. Is everything correctly traced? Is there an ongoing effort to produce clean, valid data? Is the company actually pulling together the elements to assemble a cohesive package, or are they setting themselves up for failure? Kunal Punjabi, a software expert from MindTheProduct, states that: “Ideally, building and validating the product should go hand-in-hand and be an iterative process, with some amount of validated learning along the way (or at the very least, with every iteration you make).”
Overall, V&V work is not easy and many workers do not enjoy doing it, but it is a necessity to achieve FDA approval. To learn more about how Cognition can help your company with their design controls V&V work, read the downloadable paper below!
Design Controls Series 5 Verification & Validation
Businesses want to validate software to make sure they end up with the best possible product at the end. When management asks, “Validate or fail?” the obvious, and hopefully enthusiastic, answer should be “Validate!” But can they convince engineering to do software validation? Not all companies have the luxury of hiring validation-specific engineers when they need to validate on a non-routine basis, so the regular engineers developing the product need to take on software validation. Overall, it can be a time-consuming project and no engineer really wants to take on this additional task when they have other deadlines to meet. Yet engineers do not want to be stuck validating the behind-the-scenes software they are using to build the products they are working on; they just want it to work, not take them away from their regular projects. Software validation is necessary to confirm it works in the way the company wants, though, and it’s important for the overall success of the products. It can help ensure that products work the way they were designed, and products that work improve profitability.
So for companies that want good and profitable products, why not dramatically increase the chances of success from the get-go? Cognition’s Cockpit
Platform is validated out-of-box by our own Validation Kit. This way, users can have an easier validation experience. The Validation Kit can also be used to re-validate as projects continue or as new projects arise. In addition, the kit is always updated for every major release, so nothing is left behind. It takes most of the engineers’ time out of the software validation equation and gives back their project-oriented time.
Overall, validation can be difficult and confusing, and software validation is no exception to that. We can take the difficulties out of the process. To learn more about how Cognition’s Validation Kit can help organizations like yours, read this white paper about our Validation Kit. (Download below.)
Download the latest Cognition White Paper on the Cockpit Validation Kit. This paper, written by Cherie Young, an Application Engineer at Cognition, highlights the need to obtain a fully validated requirement managment tool to help with the product development process.