Total Lean Management (TLM) Software

Pros: One of our key customers notified us they would be sending a team of 3 auditors to audit our non-existent quality system against ISO 9001 in two months. We talked to a bunch of people about software and consulting options to get us ready in that amount of time, and pretty much all of them couldn't help laughing at how impossible that would be, except TLM. The best laugh during this audit, however, was from our TLM representative connect to the audit via Teams, who after doing a stellar job helping us use TLM to get all our documents released, audits conducted, management review documented, etc., he heard one of the auditors ask, "so how long have you been ISO registered?" Needless to say, they were very happy and had zero findings to report.

Cons: This is more of a con in terms of the added cost and effort in general of implementing a fully ISO compliant quality system, which as a small company of only about 6 people, we just were not ready for yet. While we can see the benefits and have plans to implement our system at a later date, for now we have to put this on hold. Luckily TLM is able to suspend our system until we are truly ready, which is another pro for them for sure.

Overall: We can see the use of ISO 9001 only getting more prevalent as a means for customers to qualify their supply chain, so this is something we definitely need to do for real, sooner or later. If you are getting pressure to produce a quality system, I can't overstate how satisfied you'll be choosing TLM, both in terms of the software, but also in terms of their awesome support, and philosophy to build the QMS to help the company, while also being compliant.

Pros: I've been using TLM for more than 10 years, I would say it has improve overtime. With new features and easy interface. It does not require extensive training to use . It manages our ISO 17025 documentation requirements and it has the exceptional technical support whenever we require. David is always ready to assist on any issues we encounter.

Cons: Since some of our user PC does not use the same MS versions, so we have some difficulty adapting that could results on some error on the software . Nevertheless, it was resolved swiftly. It does contains quite a lot of modules , but not necessarily applicable for ISO17025, however, you have options to hide those.

Overall: In conclusion, TLM has help our company complying with ISO requirements and make progress in the business. It is a worthwhile investment to streamline your QMS requirements.

Pros: I think what I like best about TLM is the positive affect it had on my job satisfaction. If you still have to manage a paper based QMS, and convincing the boss to spend a little on software seems challenging, then this is the software that can make your daily routines much easier to manage, and the boss won't freak out about the cost.

Cost effective can often translate into dismal support, but somehow with TLM the opposite is true. They are quick to respond, and quick to update anytime I'm trying to implement something new and need a little help.

Highly recommended!

Cons: Several years ago when we purchased the software for a local installation, their new web app wasn't available. Back then I would have said the only con is that the main application is so capable, new users can feel overwhelmed as it is so easy to drill down into related information that TLM can present a lot of information all at once. For me that's a great thing but trying to get others into the system who don't live and breathe quality, they can easily get intimidated.

Their new web app solves this issue brilliantly, and new users have zero complaints and can log in and be productive with practically zero training needed!

Overall: Overall, I would say this is by far the best QMS Software option we could find for a smaller company that might still need a lot of capability and doesn't want to have surprise costs every time they wanted to expand into a new module.

Pros: Several years ago, we had the TLM staff convert our manual QMS into their TLM software product and were very pleased with the results. Recently however, we also converted to their new hosted system with the new web app and that improvement was worth leaving a review about. The hosted version has much faster performance and the web app makes document access and document control super easy to work with. We highly recommend this product, especially for smaller companies who will benefit twice, once by getting all your QMS documents under electronic control and distribution, and again by how affordable the system is.

Cons: The main TLM app still uses a Windows type of interface, and while some might think that's a con, we use the more flexible pop-up windows that the main application provides to be much more productive as we move around the software, so we understand why this administrative interface was kept as is. All of our picky users happily use the web app for their tasks, so basically the right tool for the job keeps everyone happy.

Overall: Overall TLM gets our highest recommendation! Having 30 modules to work with that don't cost anything extra when you are ready to use them is a huge plus, as is their support. Knowing there is somebody to count on if you get stuck is also something we definitely appreciate about this software over the years.

Pros: Flexibility and customer support is awesome! Our business is reinsurance and we are located in Zambia Africa. So we needed software to control and approve various document types and to process claims. TLM was able to use a combination of the Industry system setting, along with the custom field system to make a the customer feedback module handle claims that were linked to the Purchase Order module for approval of the dollar amounts along with several other features. TLM can also support our local installation with remote access and no issue has every been left unresolved or has there been any surprise costs after more than a year using TLM for managing our key business processes.

Cons: Our management wasn't comfortable with a hosted system so we are using TLM on our own server. We were also using that server for other software as well as acting as a workstation for a couple users. Somehow this created some issues with the TLM database, but the TLM support staff stuck with the issue until we finally uninstalled unnecessary software and everything is working great now.

Overall: We highly recommend TLM for any small company who needs a reliable business system to help them manage their company. It felt a little risky to set up a vendor relationship on the other side of the Globe, but TLM came highly recommended to us, so we took the risk and we are glad we did!

Pros: The best part of using TLM as a small medical device company is that is has everything we need to maintain our ISO 13485 compliance and we aren't stuck with a much more expensive system that doesn't do anything we need that TLM doesn't already do.

Cons: I can't really bring myself to list any cons. Over the years the TLM support team has been absolutely stellar at consistently addressing any issues we find very quickly, and it's all covered in their very reasonable pricing.

Overall: While Green Light Guru has been pouring resources into their marketing, which somebody (the customer) has to eventually pay for, TLM seems to be much more focused on their customers and if you are a medical device company who needs to get their quality management system in shape sooner, rather than later, we strongly recommend TLM.

Pros: We were using a QMS imported from another company, totally based on spreadsheets, shared folders, etc. and maintained by a consultant that did everything so that nobody really learned anything about what the QMS was for. He could get us through our audits, but that's all the QMS was really good for, until he wasn't available for an audit, and that's when our auditor recommended we look into TLM, as without some drastic corrective actions our certification was now at risk.

Our consultant left and took all our original Word documents with him, so we bought TLM and had Lean & Mean Business Systems (LMBS) use whatever was useful from our existing .pdf files and rewrite and release all 68 documents we needed for ISO 9001:2015 compliance. They also verified this with an internal audit of the ISO 9001 requirements as well as provided training events and records in TLM with linked videos for document management, internal audits, customer feedback, and non-conformances and corrective actions.

This was all accomplished in 4 weeks, which we didn't even realize was so impressive until we talked to a few other people who had implemented quality systems at other companies.

I think what made it possible was that LMBS could use the main app for all the "quality expert" tasks, like linking documents to ISO sections, and adding hyperlinks between related documents, and the web app allowed the rest of us to dive into verifying and editing documents as they were submitted for review and approval which was very easy to use.

Cons: I'm not really sure I can think of anything to complain about, other than the challenge of going from zero QMS experience to being one of our company's management reps. Although with the training and support we have received from LMBS so far, I'm inclined to believe their reassurances that we can do it as have other companies they have worked with who are now doing the same.

Overall: The auditor we had has been auditing quality systems for 30+ years and has seen all manner of both software and manual implementations. Even though he wasn't supposed to recommend or consult, the fact that he pointed us to TLM spoke volumes of the software's capability and credibility. We are extremely satisfied with TLM in call categories.

Pros: 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.

Cons: Admittedly getting our non-quality people comfortable with a system that has to have all the features for 30 modules was a little challenging. The fact that TLM offers unlimited licensing for the web app makes this the perfect system for a small company, as the cost of the web app doesn't go up as you grow and growing will only add limited upstream users if any.

Overall: TLM and the TLM web app completely changes the decision about when it's a good time to convert a paper based QMS into an electronic QMS software-based system. Making a paper based QMS into an actual management tool, is very difficult, and not having a QMS that can serve as a foundational management tool is becoming more and more risky and just bad for business.

TLM and the dedicated support and training staff basically makes converting to an electronic QMS a competitive advantage 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.

Pros: As a consultant, I was hired by a small medical device company to help them go through the software selection for their QMS Software. To help make the software selection process as objective as possible, we used a spreadsheet to keep track of all the different systems we looked at and to compare the key features of each.

TLM was able to upload both final draft and redline copies of the documents we wanted to release that made a big difference in our final selection, as an example of several areas we found that TLM did things in a way that was better than the others. However, I think what distinguishes TLM the most is their understanding of the full spectrum of what a small company needs for a QMS software project to be successful in the long run.

Simply put, you need both capable software, but then you need super responsive support to make sure nobody gets stuck, or doesn’t get additional support or needed features because of additional “surprise” costs.

TLM has provided spontaneous hands-on training and support as our users first learn the software, as well as the Upstream / Downstream user approach to use interface options. Once we saw they had a web app dedicated to easy access for everyone to participate in document control, and a robust application for the Upstream or Super Users, we had to add this capability to our selection spreadsheet as this feature has proven magical in getting the right people involved in the process. An issue I’ve seen other companies often struggle with quite often.

The other issue that was important to our selection process was to find a vendor that shared our relentless dedication to continuous improvement.

Cons: After reading the long history of past reviews, it's easy to see the only real drawback was that some people found the main application a little challenging to wrap their mind around. Which is understandable, considering that TLM is a QMS “Super App,” with 30 modules and all the settings and features to support needed flexibility and customization.

The fact that TLM is the only application we could find that accurately understands the needs of QMS software users and dedicates separate applications for each user type was a key indicator for me that they could see the big picture of what ISO standards mean when they talk about being Customer Focused.

The fact that they were also the most affordable of all the comparable systems simply turned an easy decision into a “no-brainer.”

Overall: While TLM is ideally suited for smaller companies who want to succeed at their first QMS implementation, all the efficiencies that make this possible are not limited to smaller companies. I would recommend TLM regardless of company size without hesitation.

Pros: I’ve used TLM more than 10 years to support the QMS for multiple medical device manufacturing companies. TLM is by far the best user experience compared with the other QMS management options available, including paper-based systems. If your company has not transitioned from a paper-based system or you’re using a clunky and difficult to manage software platform you should seriously consider changing to TLM. The support you’ll receive will make it efficient to transfer your current system so there’s no reason to delay making the change to a comprehensive, module based QMS system at an affordable price.

Normally licensing fees are not something a medical device manufacturer should rely on to make a QMS management software solution, but in this case going with a different high-cost QMS alternative that doesn’t offer the same ease of use and flexibility as TLM is not a good choice.

Earlier this year I rolled-out the web-based version of TLM to simplify the user experience for staff that doesn’t require the full desktop version. This has greatly simplified training for staff and documenting the training records. It also puts SOP’s and training records in a simple to use web interface for all staff without the need for paper-based binders. The Web app pays for itself from the savings of not having to pay for full desktop licenses for these users.

Cons: All of the TLM desktop features have not been implemented in the web-based version yet. Support is working on adding additional modules which will be very useful for remote employees and those that travel frequently.

The interface isn’t as ‘flashy’ and exciting as other QMS software. While some could consider this a con, it is not something that concerns me. My use of QMS software is purely for quality management purposes and I want an easy to navigate no frills platform that gets the job done. You could always pay more for a different flashy QMS software but why?

Overall: Most companies have a variety of vendors they need to rely on, and every once in a while, you get lucky and discover a vendor who demonstrates that above and beyond levels of responsibility and dedication to what they do for you that they are just never on your list of concerns. TLM and their support staff is one of those vendors.

Pros: 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.

Cons: The Lean Machine can function on the desktop connected to a network database, or as a Software as a Service using only a browser to access the system connected to a datacenter (hosted) database so we really don't have anything bad to say about the software.

Overall: 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.

Pros: We discovered we had ideas about what we needed after our purchase during implementation that we never would have thought of before we got into using the software, and these were issues that were definitely particular to our company.

The Lean Machine support staff is just awesome at responding and delivering updates when we needed them. After the initial implementation and validation, which was supper easy with the prewritten templates they provided with videos of the testing protocols, we are off and running and couldn't be happier.

Their new web app is adding features quickly and we'll soon be able to support most of the document related tasks via the web app, which is a huge bonus for us as we can still keep our data in-house, which was important to us to minimize the risk to our customer's proprietary data, but utilize a web based interface for most of our employees.

Cons: At first we thought that their split technology approach to the software was going to be an issue, but now that we are using both the desktop and web interfaces we totally get it. Without their desktop application, getting the changes we needed delivered promptly would have been impossible, as web technologies just aren't built for that approach. The web/cloud is great when the same thing works for everyone, but a quality management system needs to stay flexible and responsive enough to react to each company's needs to evolve, when they can see what that need truly is. The staff behind The Lean Machine seem to be one of the only QMS software companies who understand what the evolution of progress actually requires

Overall: This was a big decision for us, and we are completely confident that we nailed it! We highly recommend The Lean Machine to anyone wanting to evolve their quality system into a driver for their organization's evolution towards progress.

Pros: Easy to use, rich in features, and customer support is top notch. I also love how the companion web app continues to grow and serve the downstream users in a user friendly interface without overwhelming them. Also the most important pro of all…. TLM GETS RID OF PAPER BASED SYSTEMS!!!!!

Cons: New sleek full web version is development phases and not ready yet, but their companion web app takes care of the QMS downstream users and makes getting manager approvals of documents, deviations, training, etc very easy.

Overall: I been working with The Lean Machine for 6 years now and currently implementing for the second time as I just switched companies. The only thing I required when hired was getting rid of the paper based QMS approach and have TLM installed ASAP.

Pros: A very efficient and easy to use complete Quality Management System tool supported with excellent customer service. This tool was easy to integrate with our ERP system with minimal effort. I also love how they are so willing to work with us to make improvements as we get better at understanding what we really need the software to do for us.

Cons: After 8 years of working with TLM, I don't really have any cons.
Their ongoing support addresses any questions or concerns I may have.

Overall: Overall we highly recommend The Lean Machine. We use TLM for our ISO and FDA inspections and it always gets compliments for its simplicity and functionality.

Pros: Any business of any size..... this is a MUST HAVE! The software is easy to learn and use and the support is better than any other on the planet, David is a wizard! If your company is looking for Quality Management Software, then TLM should be your ONLY choice.

Cons: Older versions were a little slow, but we just received the latest update and it is very much improved.

Overall: We highly recommend The Lean Machine. LMBS has been one of our most reliable and trusted vendors for many years now.

Pros: David has been incredible at not only making any adjustments and customized features we need, but doing so in a timely manner. Customer support made our business's transition to this ERP system much easier than anticipated.

Cons: It's hard to think of something negative. Granted, no software can do absolutely everything absolutely perfectly, and the pace at which LMBS can develop, test, and implement changes we'd like to see to support our workflow on the production floor is such that they can make anything "negative" go away pretty quickly anyway.

Overall: Overall we highly recommend The Lean Machine. They are by far one of our most reliable vendors, and our ISO audits are a walk in the park these days.

Pros: TLM is an integrated management system that has greatly assisted us to meet the requirements of various internationally recognized standards such as ISO 9001, ISO 27001, ISO 31000 including some Corporate Governance Standards. Our company has managed to gain competitive advantage by adopting the Lean principles embedded in TLM Modules. The software is very user friendly and our rmployees really love to use it on a daily basis

Cons: We would want the web version to be concluded soonest. At the moment, we can access TLM remotely using VPN which is working fine for us. However, the web version would enable all our users to access TLM wherever they are without the need to be around the office

Overall: Fantastic!!! Excellent features that are all integrated!! TLM is just a world class software that enables organizations to achieve their strategic objectives with great ease. This is one of the best decisions we have made to invest in TLM Software

Pros: When it comes time for audits and FDA inspections, TLM is an essential tool. My customers are impressed at the speed at which I can retrieve a document or a record... and they are stunned when I tell them how much I paid for it. Notified body audits and FDA inspections are super quick as TLM links all the modules together. For example, I can show the last internal audit we did, then click through and show the CAPAs raised and then click again and show the training records of the internal auditors all within the same program.
I also like how the software is customizable to fit my workflows.
I can also rename fields to match what my company uses and not have to fit my company to a "locked-in" piece of software.

Cons: The only con is that my new company was not using TLM when I joined a few months ago. However, we fixed that by getting my new company to make the switch to TLM. An easy sell after the demo and having everyone in the company try it out.

Overall: In the words of the FDA inspector at our last inspection: "I was impressed at how quickly you pulled out documents and all the supporting evidence at once from your eQMS".

Pros: The power and depth of the tool far exceeds the price! The web app companion is tool that separates The Lean Machine from the rest it uses a very simple interface (on the web) that allows users to sign off training records (plus other features) without the need of having a license or the software installed.

Cons: Nothing I can say here about cons... Anytime I do have one Lean and Mean Business systems goes out of the way to get The Lean Machine to fit well within your business and it's needs. I also know they are working on new user interfaces for the main software which brings me back to the beginning of this statement.

Overall: I can't say enough about the software and customer service. When I initially purchased the software for our company David (CEO) was there to help get us what we need whatever the case may be and 4 years later that mentality is still there. There is no automated email saying "we will get to you within 24hours". It's direct same day contact and diagnosed quickly to keep the business running.