Cockpit Crew Blog

Welcoming Summer Intern Isaac Macrae

Cognition is excited to welcome Isaac Macrae to our Summer Internship Program. Each year, we accept a handful of students looking for real world experience in the sales, marketing, engineering, or development worlds. In total for summer 2017, we have invited three interns into the program, all landing in the development department.

Isaac Macrae

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Biomanufacturing Summit 2017: Developing Your Company’s Next Breakthrough

Communication and networking are crucial for success in any field, and the biotech industry is no exception. The 2017 Biomanufacturing Summit, hosted by the Biomanufacturing Science and Technology Consortium (BSTC), Massachusetts BioManufacturing Center (MBMC) and UMass Lowell, is an opportunity for people in the biomanufacturing field to collaborate. The goal of the summit is to get professionals and leaders of the biotech industry to meet and discuss both current challenges in the field, and the best ways to develop breakthrough technology.

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Verification & Validation: A Necessary Activity

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

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Will Systems Engineers Validate your Software? Probably Not

 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.)

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Does Management Need to be in the Office Anymore?

With the explosion of Software-as-a-Service (SaaS) and the growing population of workers based at home, the role of “the boss” is shifting.

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How we Improve the Cockpit™ Platform

How we Improve the Cockpit™ Platform

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Behind the Scenes: Cognition's User Conference 2017

The tables are set, the equipment is arranged, the giveaways (which are secret!) are packed into bags, the music is chosen, and the attendees are registered: we are ready for Cognition’s User Conference (UC) 2017!

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Cognition's User Conference 2017: The Hotel

The Boston Marriott Long Wharf is Cognition’s hotel of choice for user events; make sure to take advantage of our discounted room rates for our conference. The building is located near South Station for easy transportation access, and next to Boston’s historic North End, which contains a multitude of other activities and landmarks to visit. “Our well designed, modern rooms combine comfort and functionality for your Boston Harbor hotel stay. Terrific amenities in every room include plush bedding, well-lit work desks, and flat-screen TVs. Additional hotel perks include Fresh Bites, our in-room delivery or pick-up dining option.” - Boston Marriott Long Wharf

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Cockpit Compliance, Authority in Medical Devices

Today we are talking about Cognition’s Cockpit platform, and how it will lead your company closer to compliance with its easy-to-use, online, guided templates. One of Cockpit’s key features is helping medical device companies comply with 21 CFR 820.30. Our templates provide a master trace table which allows teams to see the connections from user needs all the way through to Verification and Validation work and testing. Cockpit provides complete end-to-end traceability for your device automatically as your engineers work.

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