Is Your Cold Chain Keeping You Up At Night?
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsThe beginning of any good engineering project — be it an insulated shipper, designing a building or bridge, building a car, space shuttle, or stealth fighter, all need to begin in the same place, defining user requirements. Engineering projects begin because there’s a need for something. Since there’s a need, the need is a requirement or set of requirements.
I’ve seen many projects go sideways or spin due to a ‘lack of’ or ‘poor’ user requirements. When you don’t have clearly defined user requirements, it allows ‘what ifs’ and ‘what abouts’ to creep in. People show up in the middle of a project and just add more because they think it’s a good idea. Never asking “do we really need this?” How many times have we all seen this scenario? By the time the project is over, did you end up with the best solution — a solution that does everything you needed it to?
User requirements can put an end to this madness and help you meet a regulatory requirement of quality by design. Defining what you require up front, and then clearly communicating those requirements to suppliers dramatically speeds up project timelines. It builds quality into the final product, and ultimately gives you a picture of what success looks like before you start. By first outlining what you require, you will know when you’ve found what you need.
Modality Solutions has developed a User Requirements Specification (URS) and decision matrix tool to expedite this process. It’s accomplished in five easy steps. The tool clearly turns your requirements into acceptance criteria.
1. The user clearly defines their requirements.*
2. Input how the vendor’s product meets each requirement.
3. Weigh the criticality of each requirement by applying a multiplier.
4. Score how well a vendor’s product meets that requirement.
5. Develop an overall score to compare against other competing products to find the product that best meets your needs.
*Having collectively designed and qualified more than 75 shippers in the past 10 years, our team at Modality Solutions can also help you set your requirements.
To summarize why at the beginning of every engineering project you need user requirements — Major League Baseball catcher and manager, Yogi Berra, said it best, “You got to be careful if you don’t know where you’re going, because you might not get there.”
In the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsIn the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read DetailsIn the highly regulated and complex world of biopharmaceutical drug products, ensuring the integrity...
read Details