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FSCA.com

ABOUT FSCA.com

Smart recall application makes the world a safer place

In healthcare, a variety of (medical) materials, tools, and equipment are used. Despite all precautions taken by manufacturers, product defects are sometimes discovered after release. When these defects are so significant that they’ve led to a calamity or a serious incident, the manufacturer is legally obliged to take action.


Secure solutions to work on increased quality in a more efficient way – Way2Web develops digital healthcare solutions.

“"Way2Web is an important partner in further developing our FSCA portal, partly because of its ISO 27001 certification”

René Drost

Streamlining recalls with a universal solution

The manufacturer may opt to recall the product or to adapt the product at the user’s location. Sometimes, a potential danger can be averted by providing the user with additional instructions on the use of the product. We call these actions a ‘recall’ and a ‘security notification,’ respectively.

To take the appropriate action, the manufacturer needs to know exactly which customer received which product and product version at what time. Moreover, it’s mandatory to report to the government what corrective measures have been taken and how customers have responded to them. Nearly everyone still does this manually, and it’s difficult to check whether a notification has been received. That is why FSCA.com devised a smart solution that can be applied universally.

Way2Web applicatie FSCA

About FSCA.com

FSCA.com ensures that manufacturers can do a recall in a simple, effective, compliant manner. The company’s web application makes it possible to approach buyers in a standardized way, regardless of the IT systems manufacturers and buyers work with. Buyers include healthcare institutions, wholesale businesses, and pharmacists.

Supporting the entire value stream

The application supports the entire value stream of a recall. It starts with creating a Field Service Notice (FSN), the official message that is sent to buyers. Who needs to get a message, which products are involved, what’s wrong, and what are the consequences or risks?

After the FSN is sent out, the application automatically registers whether the message has been received and if it’s been accepted or rejected. This is also part of a fully transparent recall. Furthermore, the buyer can indicate which action they’ve taken: put it into quarantine, destroyed it, or removed it. They can also share whether they require new or alternative products. The manufacturer that sent the FSN can keep track of all of this in a secure environment of the portal.

Finally, the application automatically generates a report, broken down by buyer and the time elapsed after the FSN was received. This helps the manufacturer comply with legal regulations and learn important lessons for the future. Examples include improving risk assessments and conducting more targeted contract reviews with buyers.

Smarter and easier to scale

The FSCA portal will be adjusted so as to enable communication with buyers before a defect, calamity, or incident occurs. The manufacturer is also legally obliged to conduct this post-market surveillance.

Results

  • Considerably shorter lead times because of a clear, transparent process
  • Covering (tens of) thousands of products and providing customized service to buyers through 5 simple steps

About the application

  • Reliable: data entry and sharing in various, secure steps
  • Unique reporting: monitoring all actions taken by buyers and translating them into useful management reports

Are you ready for the next level?

Digital transformation presents fantastic new possibilities and opportunities. Both for our company and yours too. As an IT specialist and entrepreneur, I would like to discuss this further with you, without any obligation, of course. Shall we make an appointment?

Proven results

Here, you can read more about the websites and software solutions we’ve developed in the past few years. Not only because we’re proud of our work, but mainly to show you how we’ve contributed ideas and collaborated with our clients.