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 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.

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.

We highly recommend TLM, especially now that they have their companion web app available that can fully serve the document control process with unlimited licensing. I would make this purchase before they realize they can change their pricing and make a lot more money.

TLM and the dedicated support and training staff basically makes converting to an electronic QMS a competitive advantage and there is no reason to delay. We highly recommend them, and the sooner you take the plunge and get this done, the better your business will be as a result.We were happy with the product after installing in on our local network, but then the pandemic hit, and we decided the Hosted version of TLM was going to be a better fit for us. This all happened around the time TLM launched their new downstream user web app for easy access to key, high frequency, common QMS activities and now the combination of giving our main quality people access to all the bells and whistles of the main app, and everyone access to the super easy to use web app is just brilliant. I'm not aware of anyone else delivering QMS functionality this way and guarantee you everyone will start trying to copy TLM.

At first, we thought of looking at really low cost or freeware solutions, but the QMS is just too big and too integrated not to take a multiple module / "Super App" approach. Luckily TLM was the most affordable of all the options we looked at, so it was a pretty easy decision once we found them.

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

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.

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.

TLM is allowing us to keep a brisk implementation pace in getting our ISO 13485 Quality Management System implemented. We highly recommend this software, especially if you are a medical device company who would rather spend money on getting your products to market as opposed to spending more than necessary on overly expensive QMS software.

As soon as we saw how TLM was creating a super app with every QMS Features imaginable for Upstream users and had an easy to navigate Downstream wep app for everyone else, we immediately added this criterion to our software selection QMS Vendor spreadsheet we used to score all the systems we looked at that we could afford. We also liked that all the customization and configuration was essentially self-serve as you go through the modules, so there was no waiting for the software vendor to make configurations before we could dive in.It's only been a short time, and we are already releasing procedures and working with the TLM support staff to make some updates to the web app so we can use it to support our customer feedback process exclusively in TLM.The web app does a superb job and document management, with built in tools to create hyperlinks within the documents that will open related QMS documents within the web app. Combined with tools in the main TLM app to link documents to ISO elements, risk management, and parts, we have not run into anything we need that isn't already there or being added in just a few weeks.You can also upload separate attachments to the DCO for the copy of the marked up / track changes copy of a revision change.If you are a small company < 100 employees, and have any need to digitize your business systems, whether for compliance, or just to improve how your business runs, TLM should definitely be on your short list of considerations.

The only reservation we had was that the company behind TLM was smaller compared to other systems, which admittedly has been a non-issue as the support has been stellar. Admittedly, if they were bigger the software would probably cost more, so we really can't complain.

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!

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.

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!

TLM came highly recommended to us from a colleague in our area and we are glad we took the risk in selecting TLM to help us improve our operations.

We just wanted to vouch for the TLM claim that "There is Only One Type of Quality System...Yours." We pushed that concept to the extreme by molding TLM into our main business tool for managing reinsurance claims using a combination of electronic forms, customer feedback, and the TLM Checklist feature.We can also back up all the other awesome reviews about their customer service. We are a reinsurance company in Zambia Africa and the TLM Support staff can always be engaged to address our needs and provides remote access support to our local TLM installation without any problems or surprise costs.If you haven't found anything that seems like a perfect fit, definitely contact these guys for a demo. They definitely delivered for us!

We have to use their locally installed version, as our management isn't comfortable with a hosted system. This forces a different process for updates, which is a little more work on our end, but TLM automates the process so it's barely worth mentioning. If you can, I'd recommend their hosted solution as you also get unlimited web app licenses and there is zero involvement for updates when we want to trigger them.

I would not want to tackle managing any aspect of our QMS without TLM. I highly recommend this software without reservation!

This is actually the second company I've worked at that uses TLM. I think my favorite part of TLM is their dedication to making sure I have the features needed to make my life easier. I recently had to populate the Inspection Templates for the 1667 parts listed in the inventory module. In a matter of days, we had new buttons that could copy master inspection templates from another part, as well as copy a template for all parts of a given type. This included multiple layers of data, as some tasks included links to the equipment used for that inspection step.

The only con I can think of is that their new web app still needs some features for other modules, but at the rate we are seeing the web app updated, this will be taken care of in a few months anyway.

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!

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!!

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.

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.

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.

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

The best feature of The Lean Machine is that all of our quality system needs are managed in a single software platform. The single QM software platform ensures quality system data is easily shared by everyone from manufacturing to quality assurance that is involved in maintaining product quality.

The GUI could use a make-over so it is contemporary in appearance but this is not a necessity for a utilitarian QS software platform.

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!!!

The benefits are immense....our internal business processes have been streamlined to make lean and world class......staff morale has greatly improved resulting in customer satisfaction index rising from 65% prior to the implementation of TLM Software to almost 93%. TLM has become one of our major business partner to deliver value to all our key stakeholders

TLM Software has revolutionized the way we do our business at NicozDiamond. Our internal business processes have been transformed and now exceed world-class standards- thanks to reps whose support has been exceptionally excellent. The features of TLM Modules exceeded our expectations to the extent that our employees think that TLM can virtually resolve ALL our internal issues!

None at the moment ....the fact that you can request customizations to match your company specific requirements makes TLM Software the best in the world. Our internal network connectivity has been giving us challenges to fully exploit the capabilities of TLM. Reps have been helping us to resolve the connectivity issue which is not in anyway related to TLM Software!!

C2C highly recommends the Lean Machine QMS software. It meets all of the requirements for GMP and ISO 13485, easy to use and great customer support. We have gone through 2 ISO 13485:2016 audits with no issues relating to the software.

Software has all the requirements for both GMPs and ISO 13485. Most modules are very easy to use. The system is very reasonably priced and customer support is top notch.

TLM can function on the desktop connected to a local server, or as a SaaS using solely a browser to access the system connected to a data center (hosted) database, so we really haven't had any experiences that are worth complaining about.

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!

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)

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.

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.

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.

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.

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

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.

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.

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.

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.

Excellent software for ISO 9001. Easy to use and very good customer support. We use this software everyday for all aspects of our QMS.

No cons this software is a great price, great support and is a all in one system.

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.

-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

-Not intuitive to users - Training is required and recommended -A little slow (hosted externally)

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.

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.

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.

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

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.

At times, it has slow periods but nothing dramatic

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

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.

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

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.

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.

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

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.

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.

No intranet functionality.