The FDA Compliance Crisis

Rick Bollinger, Founder and CEO of Menlo Park Software.

That black line is the industry "FDA Compliance Crisis".

How can you let your company risk getting hit with citations and bad inspections that are readily preventable?

See the flat black line on the chart?

That flat BLACK LINE on the chart in the picture above shows the problem. The percentage of inspection outcomes with voluntary or official actions required has been stuck at 40% or more for 10 years.

Just click the chart to expand it.

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

Rick has managed projects in both medical device and pharmaceutical manufacturing. His travel, work, and experience allowed him to diagnose important and hidden problems using statistical analysis, and design process improvement solutions.

YOU have the power to resolve this crisis
for everyone, including youself.

Help implement a solution that systematically
eliminates errors of omission and commission.

Click to become part of a really good solution, below.

Click to view the current LinkedIn campaign, below.

Note the frequency of 'lack of procedures' which is the citation there is no formal documentation of the requirement. People are doing the best they can. A smart tool is the solution that amplifies efforts.

Click here to get a peek at The Future and how to handle this management responsibility.

Imagine how these requirements / features will help with performance, compliance, outsourcing, remote work and pandemics.

Can we have a conversation?

What do you really worry about?

I am worried by the impact of citations, CAPA and all FDA actions from inspections.

You are not alone. The trend of FDA failed inspections with objectionable conditions or practices has been stuck over 40% for a decade.

I can't afford modular software or outsourcing if it includes manual searching for records and creation of compliance documentation.

Einstein defined insanity as doing the same thing over and over again and expecting different results.

The more that join a solution, the easier it is to build. The more viewpoints we have, the more versatile the solution will become.

Menlo Park Project™ will be the only 21st Century Internet Technology Patent Pending project management platform with QMS, collaboration and risk analysis features for Safety-Critical projects in regulated industries like smaller and growing medical device manufacturers.

"Everything is impossible until someone does it." - Arnold Schwarzenegger

Click above to Interview and get a DEMO.
By appointment only.

Let's fix this problem once and for all by turning it inside-out.

See what's coming for the medical device industry.
Just click here to peek at THE FUTURE and mold its features to match your precise purposes.

Menlo Park Project QMS/Collaboration Software

The core prototype has been developed. See how the new software will give smaller and growing firms an edge on compliance and risk management over your larger brothers. Follow the same regulations with much less manual effort.

For example, automatically turning your teams collaboration into evidence of FDA regulatory compliance and risk analysis. We just need to agree on QMS features to accept, store and use to track procedures. See a DEMO before committing to anything.

The hardest part is done. The core platform already tracks work with alerts and reports. We can design the few missing QMS parts to meet your exact needs. You'll want a DEMO before deciding.

Solutions of this scale need the help of medical device industry experts like you. An hour of your time is needed. That's very valuable. Grab your time slot. Their number is limited.

The QMS and collaboration solution for safety-critical projects in small or growing medical device manufacturers.

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

HOW TO IMPROVE INSPECTIONS AND CITATIONS

1. Eliminate errors of omission and commission, which will

2. Reduce Form 483's, Non-Conformance's, CAPA's, Device Reports and Complaints, and

3. Capture collaboration content as evidence of FDA regulatory compliance and risk analysis.

Eliminate Errors

In the core system prototype, issues, risks and tasks turn RED when overdue in dialogs, meetings and reports. And YELLOW when nearly due. This eliminates errors of omission.

The core system now also allows interested team members and stakeholders to subscribe to alerts and reminders of status and progress. Resulting follow up and review eliminates errors of commission that can 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 will be used in all stages of device manufacture. Use them for more than compliance. They will give you a performance edge.

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

HOW TO IMPROVE PROJECT PERFORMANCE

Alert stakeholders to issue, risk and task status changes and reminders. Advance your performance edge 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 and risk analysis.
Already implemented in core system prototype.

Organize work topics, issues, faults, tasks and risks. Use the resulting structure to collaborate at appropriate levels and locations without searching. Generate status reports and meeting documents to capture collaboration content as evidence of FDA regulatory evidence and risk analysis without manual creation.
Already implemented in core system prototype.

Magnify the value of outsourcing and working remotely. Integrate external teams with in-house teams despite the pandemic. Merge their collaboration by topic, issue, risk and task. Using email would require copying and pasting all over.
Already implemented in core system prototype.

HOW TO IMPROVE RISK MANAGEMENT

Define issues, tasks, risks, faults, failure modes and procedures for management in the platform. Use them to keep track of risk parameters. Facilitate Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).

Use issues, tasks, risks, faults, amd failure modes in meeting agendas to organize their content 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.

See how Menlo Park Project™ by Menlo Park Software helps the Menlo Park Associates
5 Ways Risk Management Method

Stores, tracks and enforces, (turns red and generates reminder messages), execution related to procedures, issues, tasks, risks, faults and failure modes.
Manages and documents the parameters and calculations of Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA) and Benefit-Risk Assessment (BRA).
Captures and documents all team-member collaboration related to risk analysis and safety-related procedures.

Interview
Tokens
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Tokens are good for free consulting. Until they are gone.

Get the solution you need. The one you deserve.

Want to become part of a solution to the Compliance Crisis?
(It will also help you with the Recall Epidemic)

There are 18 easy questions about how you do things. #19 and #20 are wide open.

Review and save your answers. Some might take time to look up. You could print the questions out and annotate with your answers (and your questions) and spend less time on the survey.

The survey questions are the first 20 in the interview.

If you answer a question in the survey here, we won't have to spend time on it during the interview. That means more time for the DEMO.

In the interview we check the first 20 questions. The process tries to leave the most time for the DEMO.

The interview earns you a TOKEN. It's your ticket to the after cast party. For the first 100, it's also your coupon for free consulting.

Management consulting to help implement the 5 Ways method of risk management and reduce recalls. See diagram at left.

View the current LinkedIn campaign.

Maybe, current #FDA inspection failure trends shown below aren’t called a crisis for fear that recognition would confer ownership. And, after so long, no one believes in a solution to save them.

What can a #MedicalDevice manufacturer do?

I think we can find them some genuine hope. If you think there’s a crisis, you might appreciate the Top 10 Form 483 citations. And, see hope in a potential solution that bucks an industry trend. What's in Your History Files?™
http://menloparksoftware.com

These Top 10 #FDA Form #483 Observations show errors of omission and commission in many places that easily could have been prevented.

The more that join a #solution, the easier it is to build. The more viewpoints we have, the more versatile the solution will become.

Interview for a prototype DEMO. See features in operation. Be a part of a solution and make sure it solves your problem. Decide what's in Your History Files.
http://menloparksoftware.com

Be in the first 100 to interview and contribute your expertise. Get a DEMO and see features in operation. Help turn team member and remote collaboration into evidence of #FDA regulatory #compliance and risk analysis.

Have your specific needs addressed exactly in the solution. Make sure your problems are solved. Imagine the advantage that would that give you. What have you got to lose?

What's in Your History Files?™
http://menloparksoftware.com

Click for the FDA 'Recall Epidemic' cure.
Medical device company investors: what is your vision for the industry?

In 2017 the I read an article: "What's Behind the Recall Epidemic?" The authors did identify a real problem. But, their criticism of the entire medical device industry was wrong. You can request a white-paper on the correct solution below. It's titled 5 Ways to Stop FDA Recalls. A method is described that will find and mitigate more failure modes and lower the probabilty of FDA recalls. And, it's FREE. Just request the PDF.