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.