Lean & Mean Business Systems

The Lean Machine

4.5 / 5 26 reviews

Who Uses This Software?

Progressive companies who need a partner in developing their strategies for meeting regulatory requirements so that their QMS can remain lean, efficient, and effective.


Average Ratings

26 Reviews
  • 4.5 / 5
    Overall
  • 4.5 / 5
    Ease of Use
  • 5 / 5
    Customer Service

Product Details

  • Starting Price
    $325.00/one-time/user
  • Free Demo
    Yes
  • Deployment
    Cloud, SaaS, Web
    Installed - Windows
  • Training
    Documentation
    Live Online
  • Support
    Online
    Business Hours

Vendor Details

  • Lean & Mean Business Systems
  • www.theleanmachine.com
  • Founded 2001
  • United States

About The Lean Machine

The Lean Machine: Learn how The Lean Machine, a validated and 21 CFR Part 11 compliant enterprise quality and material management software system is packed with quality and material management features including QuickBooks integration to both meet your company's performance and regulatory requirements at a price that is not an obstacle to implementation.


The Lean Machine Features

  • Audit Management
  • Compliance Management
  • Corrective Actions (CAPA)
  • Defect Tracking
  • Document Management
  • Feedback Tracking
  • Incident Management
  • ISO Standards Management
  • Knowledge Management
  • Maintenance Management
  • Nonconformance Tracking
  • Risk Management
  • Supplier Quality Control
  • Testing Management
  • Training Management

The Lean Machine Reviews Recently Reviewed!

Fantastic Software Solution. Highly recommend working with Lean & Mean Business Systems

Jun 01, 2017
5/5
Overall
4 / 5
Ease of Use
5 / 5
Features & Functionality
5 / 5
Customer Support
5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
Likely
Extremely
Likely

Pros: We have recently been recommended for ISO 13485 registration after a 4-day audit. I can honestly say without The Lean Machine software and the support, consulting and training we received from the Lean & Mean Business Systems(LMBS) it would not have been possible to make this happen! Most of my staff, some of which had been involved with ISO audits at other organizations did not believe it would be possible to implement this in the time frame allotted. I assured them it was possible because of the Lean Machine Software solution we selected. On top of that, we had to expedite the implementation of our registered quality system to ISO 13485 even more due to unforeseen issues surrounding business development activities, this put LMBS under significant pressure to support our optimistic goals, especially since we also had to comply with software validation on top of everything else. Despite all of this LMBS was great to work with, and David delivered everything promised and still managed to keep a sense of humor despite my slightly insane time table.
The software can pretty much do everything we needed it to, and being new to functioning within a robust quality system, our learning curve was pretty steep. The nice thing about The Lean Machine is that everything rolls up to your dashboard and links you to areas of the software where you have assignments waiting, so from a management standpoint I can simply focus everyone¿s attention on the TLM dashboard.

Cons: Would like the software to be somewhat faster which seems to be the case with the latest update. An update to the user interface would be nice but overall it works as expected.

Overall: We are now able to track information and act on findings and trends that where previously not available to us. We also have a system in place that ensures our employee's are all follow the same processes and procedures as soon as they are published. Our product and services will benefit greatly because of this software.

We could not be happier with The Lean Machine, both the software AND their consulting services!!!

Aug 30, 2016
5/5
Overall
5 / 5
Ease of Use
5 / 5
Features & Functionality
5 / 5
Customer Support
5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
Likely
Extremely
Likely

Comments: A couple years ago we hired a different consultant who basically gave up on us, walked out on the project and took the money with him. I was less than pleased, although admittedly our organization was probably a little more challenging than most as everyone was learning ISO for the first time.
In contrast, The Lean Machine and their consulting services not only got the job done at a reasonable price, but the auditors where noticeably impressed with our quality system especially since it was our first audit, AND we were being registered to the new ISO 9001:2015 standard that everyone was still trying to figure out how to interpret.

Although the biggest benefit from our perspective, is that LMBS trained us on how to use the system to better control how we wanted to do things and this resulted in several process improvements that we made as a team!
Being new to ISO and all their requirements, at first we were a little overwhelmed. The Lean Machine basically handles everything we needed, plus LMBS made several software updates along the way to support some of the new ISO requirements, which the auditors thought were spot on.
Technical support was also world class. We could call, or e-mail and receive same day service, often with a remote desktop sharing session to make sure the issue was resolved, and our technical support person was always supportive and easy to talk to.

My only regret is that I¿m limited to a 5 star rating¿. Overall I would give them a 6!!!

TLM is your "one stop shop" for all your QMS Needs!

Mar 08, 2016
5/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Comments: I have been using TLM for almost 10 months now (8 months of testing/development/verification and 2 months live) and I have nothing but great experiences with both the software and support. We required some custom work done and David has not hesitated once. He was quick to respond and completed the custom work quickly. David is true to his word when he says his passion is to help.
TLM is a powerful tool and really does put all your QMS needs into one great package. Once you get some time with TLM it is very easy to use and makes total sense why it was designed this way. I would recommend TLM to any company.

Great customer service, Great electronic QMS software!

Oct 02, 2015
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: Our company has been using TLM for about 5 months. Customer Service is readily available to answer any problems or questions we may have about the software. Moving from a paper system to electronic system has helped organized our company's quality system. The software can be customized to your company's needs. This software is very cost effective.

Document Change Orders (DCO)

May 14, 2015
5/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Comments: TLM has a wonderful Document Change Order (DCO) System. The system is designed to track document revisions and approvals. The DCO report that is generated as a result of changes. The report shows the revision history, approvals and trainees/date. The information and appearance of the form is fantastic. I couldn't be happier with this system!

Just had our first FDA audit with TLM

Aug 15, 2014
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: We just finished our first FDA inspection since starting production, and TLM was largely the reason we only had a few observations.

The help that LMBS provided in loading, approving and releasing our procedures and other documents as well as the ease with which I could print out the information that the inspector wanted to see made the process and outcome go much better than it would have without The Lean Machine software

A one-stop shop for all of our QMS needs!

Nov 06, 2013
4/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Comments: PROS:
- EXCELLENT customer service! Without fail, David has responded to every question, email, &
phone call within a few hours. He is great to work with and always willing to help.
- Variety of customizable modules- TLM is a one-stop shop for all of our QMS needs
- Improvements noticed with every new software update
- Bit of a learning curve at first, but easy to use once you get familiar with the software
- The training videos on the website are helpful- keep them coming!

CONS:
- Experienced some difficulties during the software installation
- Not intuitive to new users- would love to see more training videos

OVERALL:
Our organization implemented TLM document control module in September 2013. We experienced some difficulties during the initial installation of the software, but thanks to the excellent customer service and technical support, the issues were resolved in a timely manner. We now have ~113 employees using the document control module and are excited to implement more modules in the very near future.

Vendor Response

by Lean & Mean Business Systems on November 06, 2013

It's probably time we added a free new user training series as part of the purchase. It's inevitable that as the capability of the software increases, the need to train also increases. We are probably at the limit of what we can expect of users with no training.

Very Satisfied

Oct 27, 2013
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Comments: Pros: TLM has an incredibly accommodating and responsive support team. We received answers to involved questions and solutions to problems within hours, which is not at all typical of my experiences with other software vendors. We've also see this support in new updates with constant improvements, especially to the intuitiveness of the program and detailed guides to help you navigate if you are uncertain.
The program is scale-able, so it can grow with us as our operation develops more products, becomes more complex /utilizes more modules. I cannot foresee needing any functionality in the future that TLM can not or will not provide effectively.

Cons: None that I've found so far.

Overall: This was our company's first QMS/ERP software and I would definitely use TLM again if I had it over. We passed our internal audit, and are confident that we are in full compliance.
The program is solid, and their support made what could have been a painful initiation to QMS very easy. The frequent updates and scale-ability make me confident that this software will have great longevity in our company and was a good investment.

Vendor Response

by Lean & Mean Business Systems on October 28, 2013

This was the first customer review of our new 505 revision series that can be hosted or installed on-site. This allowed remote access from all project members who were able to complete this project solely using The Lean Machine as our primary collaboration tool, with a few phone calls to augmented training, process interviews, audits, and management review meetings.

Ease of Use

Aug 21, 2012
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: Easy use
Quick Response for help

Cons: Bit difficult to use in the beginning

Overall: Nice to use
Highly recomended

3 Audits in, and many good compliments

Aug 10, 2012
4/5
Overall
3 / 5
Ease of Use
5 / 5
Customer Support

Pros: After a registration audit, internal audit, and our largest customer audit i have received many compliments on our new system. I was tasked with tying two facilities under one QMS and picked TLM as our document system. We have met the needs of our QMS, and demonstrated fantastic control. The training features and document control are great. i have used other control software systems in the past and actually left one due to lack of support. TLM has not only gave unprecedented support, but has exceeded my own expectations of what customer support should look like. Pricing is by far the fairest I have come across for he value received in the package.

Cons: At times, it has slow periods but nothing dramatic

Overall: I highly recommend TLM for ease of use, ease of implementation and the awesome customer support. i cannot say enough about the support...

Extremely Satisfied Customer

Jul 31, 2012
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: I have used many ERP systems in the past and have never received the kind of customer support as I have with TLM. If there is a change that needs to be made or an improvement that our company would like to see in the software, that request is usually completed within 24 hours and usually within just a few hours. The system is extremely easy to use and implement and has all of the functionality of the systems that are 200k +. I would recommend TLM to any company that is looking for a solution to manage documents all the way from RFQ to Shipment of product and every step in between.

Cons: I have been using the system for about 2 years and have yet to find a down side to the software. This is one of the nicest and most user friendly ERP systems that is out on the market at this point.

Overall: We have just implemented a merger of 2 companies and TLM was an integral part of this merger. We have over 100 employees for both facilities and we were able to implement the system, conduct training and pass our ISO audit using this system within 6 months. The majority of the time was spent merging the business systems. I highly recommend this system to anyone looking to improve and understand the flow of products through their company.

TLM Review

May 17, 2012
4/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Pros: Great customer focus, easy to work with and I see improvements every time we get a new update

Cons: Missing some of the standard conventions that of come with MS or Apple apps, but as a legacy app, it is improving rapidly.

Overall: Would highly recommend this solution

A great alternative to the big boys

Feb 07, 2012
5/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Pros: -Diverse functionality with great document control features such as varied search filters, document obsolescence, document change orders, training lists and records
-Very easily customizable to fulfill individual needs
-Great setup of admin and management rep users and ability to switch roles
-Great customer support and service
-Price

Cons: -Not intuitive to users - Training is required and recommended

-A little slow (hosted externally)

Overall: A nifty and lean system with great functionality, I have used many other validated doc management system, each with their own issues (document stuck in workflows, incorrect revisions uploaded, ect), the design and functionality to TLM definitely address a number of the issues the bigger names have. No software is without bugs but the system easily recovers from the issues and the customer support and service is superb when needed.

Vendor Response

by Lean & Mean Business Systems on February 07, 2012

We identified the primary performance bottle neck was between the user dashboard and the document search screen, which was displaying the user's dashboard results. A new screen was designed to be solely dedicated to displaying document dashboard results, which is much faster now.

A Great Value!

Nov 02, 2011
4/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Pros: Since October 2003, The Lean Machine has been the sole source of document compliance for my organization. During that time and support has been consistently excellent and the product has provided solutions that met all of our needs as an ISO Registered organization.

Cons: No intranet functionality.

Overall: We are currently experiencing a period of tremendous growth. Because of this, we needed a broader system that could be utilized from several different locations. We found it easy to convert to TLM Enterprise, which will now support our much larger organization.

Vendor Response

by Lean & Mean Business Systems on November 03, 2011

The cons about limitations for intranet functionality were based on the Mobile version. TLM Enterprise will work over both intranet and Internet.

WAHA Laboratory's Lean-QMS Transformation

Sep 22, 2011
5/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Pros: 1) Full QMS features
2) Each Module is integrated
3) Adaptability to suit operational needs
4) Ability to set up a full QMS program with special auditing tools meeting the 500+ ISO 15189plus standards (Ontario Laboratory Accreditation)
5) Strategic Planning, Project Planning, and Task Manager module to better map out projects and programs
6) Mass Document Loading and Release feature - this was a huge time saver (we had over 1000 documents to be controlled)

Cons: 1) With the many features, there are many buttons (but these can be turned off or on) - terminology can be modified in each module that better suits the local business culture or industry
2) With some of the modules, naturally there is a learning curve but once operating, managing changes is a breeze.

Overall: When I arrived at WGH, I was facing the impossible! We were facing serious regulatory difficulties and on top of it all, an imminent inspection within 4 months by QMP-LS assessors!

There was no other solution other than the "Lean Machine" at the time that could completely transform the laboratory into an ISO compliant operation overnight.

We achieved a 92% compliancy rating after the peer inspection!

David - your Lean Machine QMS database is amazing. Thanks for the site visit consultation, the many hours of expertise you offered our lab, and a complete turn-key solution to address our regulatory compliancy challenges!

TLM enterprise for ISO 9000 Implemention

Mar 26, 2011
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: 1. AFter sales support
Amasingly fast response for suuport.
Whenever we had any problem, big or small,
TLM support team responded within 24 hours!
I am an ex IBM mainframe user in Asia,
never had this kind of treatment for a long
time till now.Using state of the art fastsupport technique,they were able to assist us as if they were sitting next to us to solve all the hiccups....big or small....not just getting us in time for the audit, but ensuring we are using every feature the right way without using too much computer storage memory.
2. ISO 9000
The time it took from installing the software to passing our first audit was a mere 4 weeks and we got the clean bill for certification albeit one minor non conformity and was allowed for followed up observation...thats all
3 User Friendly
The software was easy enough to learn that formal training was not needed. we didn't have to pay for classes or consulting to learn how to use TLM...it was just the perfect software.

Cons: No cons!
all design and management decisions are tough decisons and without control it is imposible to achieve yield and quality. TLM take over the role of a hard task master on management behalf.......its logic run the way we would do our work...from design to inventory to BOM to work order issue....from
management document control requirements in every step of the design to quality control for incoming to finishing production...

What cons? it is amasingly thorough and intelligent as a tool for management to be remote and yet able to see what is going on and to ensure no one runs high volume produciton into risks as all the design rules can be selectively enabled batch to batch!

How were we able to do that?
we just follow all the software modules built within TLM enterprise!

Overall: 4. Auditor
Our ISO auditor commented that one of our strength was knowing how to rely on software when it is typically not possible given our size today to do ISO from design to production and yet have 6 sigma with all processes under controlled.

He said he observed that we got what we wanted...(a 6 signma controlled process) via a ISO 9000 tool that uses a centralised database like TLM to start up...he was impressed with our quality system as a result of TLM.
He has never known this software before and when he realised we are a new comer to using it, he could not believe we could master it in such a short time.

5. Value for money
If we have made it to a successful company with
huge success measured the industry way,
this is one company we want to come back with and say, here is 100,000 USD,
use it for whatever development you want to do.. you have helped us so much

Best investment I have ever made!

A Plus

Mar 26, 2011
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: The Lean Machine is a very effective tool when you need the job done right. I have been working with David for many years and have never had a problem. Therefore, I recommend this product to everyone I work with.

Cons: Like every system you find a few bugs, here too.

Overall: My one, and only Con had to be the bugs one would find in any system; however, this system has the flexibility required to mold and adapt with any company. With David and his team working right along with us through every minor detail, nothing has been a problem to adjust. Outstanding job and keep up the good work.

Impressive System

Feb 09, 2011
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: This is an extremely easy system to operate and with the price is by far the best for the money. The support that you get from this system is almost instantaneous and any things that are required for your company are done within a day or two. This would never be possible from another system.

Cons: There are almost no cons for this product. It does take some time to implement, however so does every system. The could be an area where training could be conducted that wouldn't affect the real life data that has been entered. There could also be work around when trying to develop processes that template information could be used to speed understanding of later modules.

Overall: This is a fantasic system with the best customer support of any system I have ever used. I have and will continue to recommend the system to anyone looking for this type of software and look forward to working with this system well into the future.

TLM Great Product and Superior Support

Jan 22, 2011
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: This software has it all and at a more than reasonable cost. We have used software developed by David for the past 10 years for our complaint handling, we were more than happy when he came out with TLM and realized that it could do so much more for our ISO 13485 company. It has served us well through many ISO and FDA audits, an FDA auditor even asked for the name of the software. Customer support has been very helpful in fine tuning the software/reports to meet our specific needs for audits, even ones requested a day before the audit. The software is straight forward to use, we have 8 personnel in two different locations using it seamlessly. TLM machine has the best customer support I have ever used, problems and requests for help were answered quickly and efficiently.

Cons: Not knowing what goodie module to use first, seriously this software has so much it can be addicting spending time exploring all the modules.

Overall: If you are looking for a software package that has it all this is certainly worth purchasing. I would recommend this to anyone who needs a complete software package to satisfy their compliance needs, its hard to find software and customer support that both work well and TLM does both.

TLM Review

Nov 12, 2010
4/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Pros: TLM has all of the features that we were looking for to meet the stringent requirements mandated in the aerospace industry. Functions that were not in TLM that we needed, the Tech Support at TLM implemented all of the functions we had requested. For being in compliance with ISO standards this is the best software we have used.

Cons: So far any issues we have had with the software TLM has resolved them in a very timely manner.

Overall: I strongly recommend this software for companies looking for the complete package. We selected this software because it can handle all business functions in one program. Also what sold us was the customer and not having to use multiple software programs. This is great product.

Outstanding product, service and support

Nov 12, 2010
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: The Lean Machine is 10 out 10 in ease of use, flexibility, functionality, service and support. We are currently using it to manage our clinical diagnostic lab, and with the help of David Smithstein, have been able to customize the system's function to allow us to manage our entire production process from ordering materials, through generating work orders, to managing all quality documentation, to tracking inventory and WIP, through to managing incoming patient specimens and all the way to sending patient test results, all within the Lean Machine system. There is not a product for GMP or GLP document and manufacturing control that compares to the Lean Machine in capabilities at such an incredibly affordable price.

Cons: We have seen a great improvement in speed and ease of synchronization with the Lean Machine Enterprise version.

Overall: This is the second FDA regulated company that I have used The Lean Machine for managing the manufacturing process and controlling documentation. The software has been invaluable to every facet of my production operations. I have looked around and I am completely confident that there is not a better value out there for a system that gives complete lot number traceability, bill of material management, work order processing, and document version number control. The incredible service and support that the company gives in addressing questions is invaluable "icing on the cake." I am not sure when David sleeps, but his responsiveness in support is par excellence.

Vendor Response

by Lean & Mean Business Systems on November 14, 2010

Actually, we get plenty of sleep. It only seems like we don't because it's hard to imagine how we can consistently provide the combination of top notch product and service we do without burning the mid-night oil. We just maximize the impact of the waking hours we do have by practicing what we preach and building lean processes within our own organization. You can't do anything for 10 years that causes you to lose sleep; the body just won't tolerate that much neglect for that long. And of course we use our own product. "Killing two birds with one stone" is an SOP at LMBS.

TLM review from Singapore

Nov 08, 2010
3/5
Overall
3 / 5
Ease of Use
4 / 5
Customer Support

Pros: We are a calibration laboratory seeking accreditaion for ISO17025 located here in Singapore. We had been using TLM for years, as part of our documentation requirement. The good thing about this software is the ease of making changes and update. David was able to support us on update and installations quickly & easily even though we are located in a different time zone.

Cons: TLM was pattered according to ISO 9001, that is why some features are not applicable to us, even so, we are able to use the software for our management requirements.

Overall: Highly recomment as management tool software for those seeking accreditation for ISO.

World Class Support

Nov 04, 2010
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: The Lean Machine has changed the way we handle Quality Assurance at Osteogenics. The system saves us time and helps us coordinate complex projects. Implementation was very fast. We were up and running on many of the modules immediately. The Lean Machine staff are world class. Any feature requests or technical questions are quickly addressed.

Cons: We have not experienced any cons.

Overall: I would highly recommend The Lean Machine to any company wanting to improve the efficiency and effectiveness of their QA processes. It will save you time and money.

Highly Functional Software with Superior Support

Oct 28, 2010
5/5
Overall
5 / 5
Ease of Use
5 / 5
Customer Support

Pros: This easy to use, highly adaptable software has made short work of developing and implementing our quality plan. When I've needed help or had an idea on how the software could better serve us David has fielded the questions and challenges promptly and effectively. The interactive modules help keep us lean and mean.

Cons: I'd like a report writer to create/modify forms.

Overall: The best value in Quality and Lean Management software by far.

Vendor Response

by Lean & Mean Business Systems on November 01, 2010

We like to add any needed reports for several reasons: 1. It saves our customers a lot of time figuring out how to create reports. 2. It gives us insight to what is needed and often a request in one area of the software will drive improvements in other modules. 3. We can make sure the report is accurate, since we are more familiar with the underlying data structure and relationships between the various tables involved in the report. 4. We can build in any needed flexibility so other users might find the report useful as well.

The Lean Machine

Feb 06, 2010
5/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Pros: Excellent version & checkout control, management control. The ability to designate certain classes of documents and then list per the classification is helpful. The distribution control of controlled documents works well.

We like the super fast response from customer support. Also, the software designer is open to special improvements to assist our workflow and data integrity. There was one instance when we were actually undergoing a FDA inspection and a version control deficiency was identified and that same day David Smithstein implemented a fix that has been made a permanent feature in the software.

Of particular value to us is the quick search features that allow us to locate specific documents by various means. In a recent FDA inspection the inspectors commented on the easy location and presentation of documentation they requested.

We constantly modify our documents and the version control and saving of historical versions is excellent.

Highest Recommendation!!

Cons: There are too many screens for the review and approval of existing documents. It would be nice to have a one click "review and release" button for documents that haven't changed but require review every 12 months.

The individual screens can not be increased in size.

Overall: I have recommended TLM to auditors, inspectors and fellow regulatory and quality professionals over the last 5 years. I looked at many QMS packages when we started our company and TLM was not a front runner then, they were a small company with a fledgling product and it has grown and improved over the years into an excellent product that I am comfortable continuing to recommend.

Five Stars!

Vendor Response

by Lean & Mean Business Systems on November 12, 2010

Based on Jim's input we developed a "no change" review process. Now it is easy to record the review of a document to meet regulatory requirements, but only one screen that lists the documents needing review is needed. Naturally this screen is tailored to the individual user, opens from their dashboard, and only displays documents they are the owner of.

Atlas

Jan 11, 2010
4/5
Overall
4 / 5
Ease of Use
5 / 5
Customer Support

Pros: Efficient all in one system. We use it to mange Quality records as well as equipment records.

Cons: Inventory Migration out to Quickbooks was not developed for our needs.

Overall: I would recommend this system as a one platform serves all. Its encompasses a quality management system you would usually only find across a much larger more expensive system or only with Purchases with Multiple systems.