Wer nutzt diese Software?

Fortschrittliche Unternehmen, die bei der Entwicklung ihrer Strategien für die Erfüllung regulatorischer Anforderungen einen Partner brauchen, damit ihre QMS schlank, effizient und effektiv bleibt.

Durchschnittliche Bewertung

30 Bewertungen
  • Gesamt 4.7 / 5
  • Benutzerfreundlichkeit 4.5 / 5
  • Kundenservice 5 / 5
  • Funktionen 4.8 / 5
  • Preis-Leistungs-Verhältnis 5 / 5

Produktdetails

  • Startpreis 325,00 $/einmalig
  • Kostenlose Version Nein
  • Kostenlose Testversion Ja
  • Einsatz Cloud, SaaS, Web
    Installiert - Windows
  • Training Live Online
    Dokumentation
  • Kundenbetreuung Support während der Geschäftszeiten
    Online

Angaben zum Hersteller

  • Lean & Mean Business Systems
  • http://www.theleanmachine.com
  • Gegründet 2001

Über The Lean Machine

The Lean Machine: Erfahre, wie die Lean Machine, ein validiertes und 21 CFR Part 11 konformes Enterprise Qualitäts- und Material-Management-Software-System, voll gepackt mit Qualitäts- und Material-Management-Funktionen einschließlich Quickbooks-Integration, um sowohl die Leistungs- als auch regulatorischen Anforderungen deines Unternehmens zu einem Preis zu erfüllen, der kein Hindernis für die Umsetzung ist.

The Lean Machine Funktionen

  • Beschwerdemanagement
  • Compliance Management
  • Corrective and Preventive Action (CAPA)
  • Dokumentenkontrolle
  • Geräte-Management
  • ISO-Standard-Management
  • Instandhaltungsmanagement
  • LieferantenQualitätskontrolle
  • Risikomanagement
  • Trainingsmanagement
  • Verfolgen von Fehlern
  • Wirtschaftsprüfung-Management

Die hilfreichsten Reviews für The Lean Machine

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

Bewertet am 1.6.2017
Sean C.
Director of Operations
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
5/5
Gesamt
4 / 5
Benutzerfreundlichkeit
5 / 5
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
5 / 5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: 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.

Vorteile: 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.

Nachteile: 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.

TLM enterprise for ISO 9000 Implemention

Bewertet am 26.3.2011
L S.
Dr
Quelle des Nutzers 
5/5
Gesamt
5 / 5
Benutzerfreundlichkeit
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
Preis-Leistungs-Verhältnis

Kommentare: 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!

Vorteile: 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.

Nachteile: 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!

The Lean Machine

Bewertet am 6.2.2010
Jim K.
President
Quelle des Nutzers 
5/5
Gesamt
4 / 5
Benutzerfreundlichkeit
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
Preis-Leistungs-Verhältnis

Kommentare: 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!

Vorteile: 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!!

Nachteile: 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.

Antwort des Softwareanbieters

von Lean & Mean Business Systems an 12.11.2010

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.

Outstanding product, service and support

Bewertet am 12.11.2010
Ray J.
President
Quelle des Nutzers 
5/5
Gesamt
5 / 5
Benutzerfreundlichkeit
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
Preis-Leistungs-Verhältnis

Kommentare: 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.

Vorteile: 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.

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

Antwort des Softwareanbieters

von Lean & Mean Business Systems an 14.11.2010

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.

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

Bewertet am 30.8.2016
Don R.
President
13-50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Quelle des Nutzers 
5/5
Gesamt
5 / 5
Benutzerfreundlichkeit
5 / 5
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
5 / 5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: 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!!!

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