The Lean Machine™ – Excellence Through Integration

admin — Mon, 23 Jan 2012 15:05:53 +0000

The Lean Machine ™ is a collection of software modules that allows a company to meet ISO and FDA requirements while maintaining the flexibility to become a growth oriented, learning organization.

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Custom Development Example

Do your business systems work together?

If your company……

1. Is a Medical Device/Pharma or other Start Up…. The FDA doesn’t care how big or small your company is, you have to meet the same requirements regardless of the resources you have to do so. Plus, if your company is running on someone else’s money, the clock is ticking and the time you have to demonstrate success is not unlimited. The Lean Machine will instantly provide you with the systems (document control, training, CAPA, etc) that FDA, GMP, and ISO requirements say you need to have. Plus you will save huge amounts of time using electronic signatures, collaborating remotely, distributing electronically, and not having to convert a paper based system down the road.

2. Has outgrown its disconnects systems. A standalone program for this, an Excel spreadsheet for that, maybe a home grown database and pretty much everything else on paper got you to where you are today, but the time spent finding, fixing, or entering information is starting to hurt productivity. The Lean Machine will give you back all that time spent on issues related to being disconnected, allow you to collaborate better, provide management better visibility and “Business Intelligence,” and lower your audit anxiety.

3. Needs a $100,000+ material management / accounting system because you’ve been in business for a while now, you’ve grown, but that system you bought 10 years ago just isn’t working like you need it to. Maybe you’re using QuickBooks for your accounting, but even their newest products don’t have the robust lot/serial tracking, inspection, or flexibility you need to integrate Quality/ERP/CRM and create a closed looped system that will hit your books in a way that works for your business. Unfortunately all the system you’ve looked at are way out of range of your budget after you add up all the implementation and training costs. The Lean Machine has robust material management controls, integrates with QuickBooks, and can potentially provide you a $100,000 solution with a small development project that only adds a small percentage of that cost to our baseline licensing cost.

4. Has material management and accounting under control, but your ISO based quality system is still pretty much all on paper and really just takes a lot of time without adding that much value. The Lean Machine can help you transform your quality system into more of a management system. It took a lot of work to get certified, and to change your company culture enough to understand the importance of procedures, why not harness that investment by streamlining the information flow it generates so that it can start giving back insight to root causes and employee work loads so that corrective actions and continuous improvements are more effective and happen faster?

Of course The Lean Machine will also speed up your ISO 9001/13485 certification, but that’s the easy part. Using your quality system as a proactive management tool is where most companies find the real challenge to be. If you are simply looking for document management software, or ISO 9001 Software, The Lean Machine will meet your initial needs and then allow you to integrate other quality improvement and lean manufacturing solutions when you are ready to expand the scope of your process improvement efforts.

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Third party validation is also available for medical device or other companies who are required to use validated software to meet FDA, ISO 13485 or ISO 9001 requirements. We also love it when our customers give us suggestions for future updates so we can make sure their quality management software is acting like the management tool it is supposed to be.

Watch areospace customer testimonial: Testimonial video

Whether your issues are supplier quality, internal audits, or lean manufacturing, having modules for all your needs in one integrated quality management software package becomes a significant strategic advantage. We also provide you with world class support and updates to ensure The Lean Machine is working to support your quality improvement and compliance management efforts as your business systems evolve.

Benefits of an integrated 21 CFR Part 11 compliant Quality Management Software System

Save countless hours by not moving paper, looking for paper, printing paper, signing paper, organizing paper, hole punching paper, finding obsolete paper, etc.
Save countless hours by using the Employee Dashboard to focus on the tasks you need to accomplish.
Avoid the problems that occur when these tasks get perpetually postponed because they are forgotten, or lost.
Save countless hours trying to develop isolated components of your quality systems that can’t exchange information.
Make sound decisions from your quality data that’s easy to capture and report on.
Save even more time not duplicating data entry as all the module are integrated to maximize the use of data from other modules.

Using quality management software for your process improvement efforts can accelerate your organizations progress towards a lean manufacturing environment by coordinating areas such as supplier quality, document management, and process improvement. Quality control and risk management are achieved under one quality management system that eliminates the wasted efforts of duplicate data entry or trying to manually integrate separate databases or spreadsheets.

The Lean Machine™ | Lean ISO 9001 | Quality Management Software | Document Management Software| ISO 9001 Software | Lean Manufacturing | Supplier Quality

The Lean Machine™ – Excellence Through Integration

Log into the TLM Enterprise demo

Custom Development Example

If your company……