When the FDA’s 21CFR Part 4 requirements for combination products went into effect, we needed external support to ensure our design history files were clearly established. We contracted Quality Solutions Now, Inc. who was able to quickly provide us with 4 resources that were experts in design control.
A solid team approach was taken and a project charter was established, a stakeholder analysis was conducted, and a communication plan was developed. They also developed a detailed schedule to ensure all tasks and deliverables were tracked so that project risks could be appropriately mitigated. We are confident that our project may even come in ahead of schedule.
For making sure that all strategic and tactical details are taken care of, We recommend Quality Solutions Now, Inc. for superior project management support.
I have been utilizing Quality Solutions Now to provide Project Management support services within our Supply Chain organization for nearly a decade. We have a very diverse and ever evolving Project Portfolio. QSN has consistently provided Project Management professionals who fulfill our expectations and can effectively translate project specific requirements into clear tasks, deliverables as well as definable roles and responsibilities.
QSN designed and implemented a complete quality system for my medical device business. Their service was professional and efficient, both from a cost and time perspective. While I had always suspected that QSN had provided me with a first rate quality system, the proof came when the FDA announced a complete audit of my business on very short notice. QSN gave me full support for the audit itself on a very tight time schedule and my business passed the audit with no observations. I could not be happier with their service and wholeheartedly recommend them.
Quality Solutions Now (QSN) has been working with our company for approximately 6 months now and the work that has been completed for us has been of the highest quality and accuracy. When I first contacted QSN early last summer and explained the type of support we needed, QSN managing partners quickly located several individuals within QSN that would be available either immediately or within a short period of time. QSN did not waste our time by sending someone we had to educate before that person could be productive and provide us what we needed.