The FDA Compliance Crisis

See the flat black line on the chart?

The flat BLACK LINE on the chart in the picture above shows the problem. Note the percentage of inspection outcomes with voluntary or official actions required.

He came across this while researching another medical device industry problem (the "Recall Epidemic"). This time we could call it an "FDA Compliance Crisis".

Click the chart to expand it.

Rick Bollinger, CEO and Founder of Menlo Park Associates, is a management consultant with decades of project management experience. Recognizing and solving process problems was his day job for many of those years.

He managed projects in both medical device and pharmaceutical manufacturing. His travel, work, and experience allowed him to design and build his prototype project management platform.

The percentage of FDA inspections with actions has been stuck between 30% to 40% for a decade.

Why haven't QMS systems fixed this for 10+ years?

That's the "FDA Compliance Crisis".

He discovered that his new project management platform could solve it!

So, why haven't QMS software vendors solved this?

After all, wouldn't you rather be stuck between 0% and 10%?

The solution is software. But, not more of the same old QMS software that used to run on Modular Mainframe computers.
And, certainly not more outsourcing.

The FDA Compliance Solution is 21st Century collaboration software with the right QMS features.

Schedule Interview / DEMO

Clicking this button will connect you to the digital schedule.

If you can only spare a half hour, only take the internet survey. Same questions. No demo. Just click the servey button below.

Menlo Park Project QMS/Collaboration Software

You can help me finish designing and building it. We don't need to start at zero. I've already designed and developed a core prototype. We just need to add QMS features: accepting procedures into a project, and so on. Whatever you can think of. Give it your best shot. See a DEMO before to commit to anything.

The hardest part is done. The core platform already tracks work with alerts and reports. Maybe we can design missing parts with these hours we are stuck at home because of the CVD-19 virus. Perhaps make that happen to meet your exact needs.

Solutions of this scale need the help of medical device industry experts like you. But, your blood is not needed. Neither is your plasma. An hour of your time is needed. That's more valuable.

Your help knowing this effort is on the right track is needed.

Let's fix this problem once and for all.

See what's coming for the medical device industry.
Just click here to peek at THE FUTURE.

It would be helpful to interview you.

Imagine the power of your industry experience, and that of your peers', in interviews. And, in seeing demonstrations using Zoom, or whatever.

Together, we can design a better future. Better software.

Improves inspections and citations.
Improves project performance.
Improves risk management.

Adding QMS features to core platform

Prototype core features are ready for new designs to hold, enforce and document QMS / SOP procedures and generate regulatory evidence of compliance. You may verify them with your experience and imagination and compare them to FUTURE PLANS.

See below how to improve things and get a DEMO.
By appointment only.

HOW TO IMPROVE INSPECTIONS AND CITATIONS

Reduce Form 483's, CAPAs, Non-Conformances, Device Reports and Complaints.

Eliminate errors of omission and commission.

Capture collaboration content as evidence of FDA regulatory compliance.

Eliminate Errors

Issues, risks and tasks turn RED when overdue in dialogs, meetings and reports. And YELLOW when nearly due. That will eliminate very many errors of omission.

Interested team members and stakeholders may subcribe to alerts and reminders of status and progress. Resulting follow up and review will eliminate many errors of commission that would spoil FDA compliance.

Fix FDA Regulatory Compliance

QMS and regular SOP procedures will be stored by the new software and dropped into projects to define work for team members. Procedures can be used in all stages of device manufacture. Everybody gets to look good. Especially you.

Execution related to issues, risks and tasks is tracked and enforced. They show up in alerts, status reports, and meeting agendas and minutes. All generated automatically, including coll-aboration content, for history records and files to provide evidence of FDA regulatory compliance. This feature is PATENT PENDING.

HOW TO IMPROVE PROJECT PERFORMANCE

Alert stakeholders to issue, risk and task status changes and reminders. Save time by generating status reports and meeting agenda and minutes documents instead of creating them manually. These serve as traditional operational documents, as well as evidence of FDA regulatory compliance.

Use the new project management platform to organize work issues, tasks and risks. The resulting structkure could then be used to collaborate at appropriate levels and locations. Lastly, generate status reports and meeting documents to capture collaboration content as part of regulatory evidence without outsourcing or manual creation.

HOW TO IMPROVE RISK MANAGEMENT

Define faults/failure modes and procedures for management in the platform. Use it to keep track of risk parameters. Export them for Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).

Use them to organize meetings to bring the right people together and follow a method that iteratively and incrementally reduces risk probabilities. Request your copy of the the method below. Or, see more about the RECALL EPIDEMIC.

TOKENS
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