Want your complaint system to be FDA compliant? There’s an app for that with a new cloud-based system to allow medical device companies to process paperless and compliant complaints required by FDA regulations.
San Francisco-based FastQS announced the launch of its Complaint Management Solutions program on November 4, 2015.
Most device companies use a highly manual, paper-based complaint handling process to comply with requirements of the Code of Federal Regulations Title 21 enforced by the FDA through regular inspections. Going to the cloud lowers the risk for data loss and security concerns, says the company in their announcement.
The company says it has taken industry best practices from regulatory experts and put them into their system. “FastQS is about changing the way we see quality in the medical device industry. We believe that providing affordable regulatory solutions will drive improved patient safety and reduce overall healthcare costs.” said Alvin Tai, CEO and co-founder of FastQS.
Here is what the company offers:
- Compliancy: FastQS is compliant to FDA CFR Title 21 Part 820 – Quality System Regulations, Part 803 – Medical Device Reporting and Part 11 – Electronic Records; Electronic Signatures.
- Trending Codes: Assign relevant codes to each complaint for advanced trending capabilities. Identify quality issues quickly and accurately.
- Complaint Network: Link complaints to a similar “master” complaint to avoid repeating unnecessary investigations.
- RMA Link: Connect with an externally generated RMA [Returned Merchandise Authorization] number to link complaints with returned material.
- Quick Setup: FastQS provides all the necessary procedure templates, software validation documentation and guidance to quickly integrate with any quality system.
Affordable
This may be particularly attractive to small device companies with a limited budget since the system was designed with the regulations in mind and very little customization or maintenance is required. Their pricing is simple. It’s $60 per month for companies marketing FDA approved or cleared devices. If your product is in a clinical trial, the program is free.
In addition to meeting legal and regulatory standards, the system also meets ISO 13485 requirements.
Tai has implementing quality and regulatory systems for companies such as Stryker and Mindray Corporations, and has spent several years as a consultant for successful device startups.
