As we know, companies can find themselves in hot water at times with the FDA when it comes to regulations and procedures around complaint management, which can be a mess to straighten out. Medical device companies (ahem…Theranos) are no different, but software products to make these processes easier, or avoidable, are rarely tailored specifically to these types of companies.
FastQS, a California-based startup created by regulatory consultants and software experts, today officially launched cloud-based complaint management software designed to eliminate the use of paper records and manual reporting and essentially provide a foolproof option to prevent complaint complications.
As FastQS CEO and co-founder Alvin Tai explained in an interview, many (if not the majority of) small to medium-sized device companies are still using paper-based processes for handling complaints. Not only does that increase the risk of data loss and security concerns because people can misplace documentation or simply forget to report complaints, it’s also very expensive.
The FastQS application is designed with specific, relevant medical device regulations and compliancy in mind, so there is very little need for companies to customize to fit their company’s needs.
As Tai pointed out, Theranos, for example, could have been doing all of the right things following complaints about its “nanotainers,” but the company just may not have been documenting it. “It’s hard to prove that you did something without actually showing that someone signed off on something or that it was written down,” Tai said. “The FDA is a stickler for documentation, obviously.”
Software such as FastQS’s can serve to eliminate some of these potential issues, and it’s a lot less expensive than hiring a consultant. For device companies still in clinical trial phase, use of the product is free, and it is $60 a month for those who have received FDA approval.
Tai acknowledges that there is still some room for human error with the software, for instance if someone neglects to enter in information altogether, but assuming everything is entered, it’s there for good, all in one place.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The company has also made a point to hopefully prevent potential liability issues. “You can still misuse our product, if you try,” Tai said. “We take testing and security very seriously, so we try to mitigate our own risks by doing in-depth tests.”
Photos: FastQS
