SimplerQMS vs. Total Lean Management (TLM) Software Comparison


SimplerQMS	Total Lean Management (TLM) Software Lean & Mean Business Systems	+	+
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		Related Products isoTracker Quality Management isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category. 19 Ratings Visit Website Qualio Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling 919 Ratings Visit Website SBS Quality Management Software Affordable QMS Software for Small and Midsize Organizations The SBS QMS Suite is an integrated Quality Management System (QMS) software solution designed to help small and midsize manufacturers and other quality-driven organizations efficiently manage ISO 9001 and related quality requirements. Five specialized modules provide document control, employee training, CAPA and nonconformance management, audits, risk management, calibration, preventive maintenance, supplier management, inspection and SPC. SBS QMS Software is available as a cloud-based or locally installed solution and uses flexible concurrent-user licensing. Organizations may implement the complete QMS Suite or purchase individual modules to fit their quality system requirements and budget. Professional QMS capabilities without the enterprise price tag. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - Environmental Health and Safety (EHS) module SBS Ground Control - Employee training management (LMS) - Document control - Change Control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans For a small or midsize manufacturer seeking ISO 9001 QMS functionality without enterprise-level cost and complexity, SBS QMS Suite is an option worth considering. 7 Ratings Visit Website AlisQI AlisQI is a modular, cloud-based Quality Management platform for process and batch manufacturers who want to reduce firefighting, improve predictability, and stay compliant by default. Unlike traditional EQMS platforms that were built around documents and later adapted for analytics, AlisQI was designed from the start as a data-first system. Quality, lab, and production data are structured and connected in one operational backbone. That foundation now enables practical AI capabilities inside daily workflows. Manufacturers can automatically extract data from diverse supplier COAs without predefined templates, generate structured digital forms from existing files or plain language, query their QMS conversationally, and detect recurring incident patterns across sites. Core modules include Document Control, Training, Deviations, CAPA, Audits, Risk Management, Supplier Quality, SPC, and EHS, supported by targeted out-of-the-box Solvers that address specific operational problems. 108 Ratings Visit Website Intelex Intelex is an integrated software solution for managing Environmental, Health, Safety and Quality (EHSQ) programs. Intelex’s scalable platform is designed to store, manage and analyze EHS and Quality data in one place. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: - Drive better results in your EHSQ program by monitoring workflows to achieve top performance and gain control. - Identify trends and tendencies by setting goals to gain greater insight into your EHSQ program to enhance judgement. - Reduce incidents and administrative work by easily monitoring, managing, optimizing and drawing insights from your safety data with our user-friendly safety software solution. - Streamline air, water and waste emissions management and reporting, and track and manage environmental outputs to achieve sustainability goals. - Drive continuous quality improvement activities across multiple departments, sites or locations. 193 Ratings Visit Website Interfacing Integrated Management System (IMS) Interfacing’s Integrated Management System (IMS) is an AI-powered platform that unifies BPM, QMS, Document Control, and GRC into one platform. Organizations use IMS to model and automate processes, control documents, manage risks, and maintain regulatory compliance with full traceability and audit readiness. Built for highly regulated sectors such as aerospace, life sciences, finance, and government, IMS provides real-time visibility, automated workflows, and AI-driven insights that improve quality and reduce operational risk. The platform is ISO 27001 certified and fully validated for 21 CFR Part 11, making it suitable for mission-critical environments requiring strong governance, security, and control. IMS also includes low-code automation, process mining, audit management, training tracking, CAPA workflows, and dashboards to help teams streamline operations and continuously improve. AI strengthens governance, improves accuracy, and reinforces regulatory control. 66 Ratings Visit Website HSI Donesafe HSI Donesafe is a no-code, cloud-based EHS software that simplifies safety, compliance, and risk management, transforming complex processes into user-friendly workflows. Trusted by industries worldwide, Donesafe allows organizations to track, manage, and report on essential EHS functions from one central platform. Our software adapts to your team’s style, enhancing everyday workflows with effortless compliance and smooth operations. Keep pace with evolving regulations and standards, from incident reporting and audits to training and risk assessments with Donesafe. Unlock peace of mind with: - Workflows that flex to meet ever-changing regulations - Instant insights, keeping you confident in real-time safety tracking - A scalable platform that grows in step with your team’s journey - Simplified compliance that makes audits and reporting a breeze Put safety at the heart of every day with HSI Donesafe; protect your team, simplify compliance, and ensure everyone goes home safe. 176 Ratings Visit Website Certainty Software Improve Performance and Sustainability with Certainty! Certainty is an enterprise-level software solution to easily collect and report inspection data and manage issues identified. Used by hundreds of thousands of professionals to complete millions of audits and inspections annually, Certainty helps companies around the globe ensure compliance, reduce risk, and improve performance with easy-to-use forms, real-time reports, and complete action management. Collect, track, and report accurate and powerful data to provide detailed business insights that will empower your team to improve performance and business sustainability. Certainty is used worldwide for: Safety inspections Quality assurance and control audits Supplier and supply chain compliance audits ESG assessments And much more . . . 93 Ratings Lockbox LIMS A sample tracking, test result capture, and inventory management cloud LIMS for life science research, biotech/NGS, and industrial QC labs. Includes regulatory support for CLIA, HIPAA, Part 11, and ISO 17025. Nothing is more critical to a lab’s success than the quality, security, and traceability of samples. The Lockbox LIMS system provides robust sample management functionality to laboratory professionals, giving them full visibility on every aspect of a sample’s journey, from accessioning to long-term storage. LIMS analysis is about more than just tracking results- Lockbox’s multi-layered sample storage and location management functionality allows you to define your lab’s storage framework using a variety of location options: rooms, storage units, shelves, racks, boxes, and positions. 72 Ratings Visit Website Propel Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. Agentic AI accelerates change reviews, surfaces BOM and quality risks, enriches product information, and guides decisions—while role-based permissions and audit trails protect IP. From design through manufacturing and commercialization, Propel empowers companies to deliver innovative, high-quality products faster with greater confidence. Each module deploys independently with no required dependencies. 215 Ratings Visit Website
About SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.	About Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work Orders
Platforms Supported Windows Supported Mac Not Supported Linux Not Supported Cloud Supported On-Premises Not Supported iPhone Supported iPad Supported Android Supported Chromebook Not Supported	Platforms Supported Windows Supported Mac Supported Linux Supported Cloud Supported On-Premises Supported iPhone Supported iPad Supported Android Supported Chromebook Supported
Audience Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.	Audience The perfect QMS software and implementation solution for your small company that you can grow into.
Support Phone Support Supported 24/7 Live Support Supported Online Supported	Support Phone Support Supported 24/7 Live Support Supported Online Supported
API Offers API Supported	API Offers API Not Supported
Screenshots and Videos View more images or videos	Screenshots and Videos View more images or videos
Pricing $13,750/year Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc. Free Version Not Supported Free Trial Supported	Pricing $45/user/month Contact us for pricing. TLM Web App has unlimited licensing so you will only need a few main application licenses. Free Version Supported Free Trial Supported
Reviews/Ratings Overall 1.0 / 5 ease 1.0 / 5 features 1.0 / 5 design 1.0 / 5 support 2.0 / 5 Read all reviews	Reviews/Ratings Overall 5.0 / 5 ease 4.9 / 5 features 4.9 / 5 design 5.0 / 5 support 5.0 / 5 Read all reviews
Pros & Cons from Real Users Pros The technical staff were the best part of our experience. During onboarding they made a real effort to explain how the system works and to help whenever we had questions, and they were responsive and patient throughout. The platform is built on Microsoft Azure and Microsoft 365, so documents live in a familiar SharePoint/Office environment rather than in a completely proprietary system. Cons In our experience the system is extremely inconvenient, cumbersome and inflexible. Everyday document work requires far more clicks and steps than it should, the interface is heavy, and adapting the workflows to how our company actually operates proved impractical. After evaluating it we decided not to implement it at all. The far bigger problem is the commercial side. Read the termination and renewal provisions extremely carefully before signing. Based on our experience you cannot simply stop using the service during the contract year and stop paying. Notice must be given at least 90 days before the renewal date; miss that deadline and you may be invoiced for another full contractual period even though you no longer use the system. Termination must be submitted in writing and its receipt expressly confirmed. We told the company twice by telephone that we wanted to discontinue the service, and those conversations were not treated as formal notice. Do not rely on phone calls: send written notice, request written confirmation, and keep all correspondence.	Pros & Cons from Real Users 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. 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. 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! 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. 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 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. 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. 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! 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. 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.
Training Documentation Supported Webinars Not Supported Live Online Supported In Person Not Supported	Training Documentation Supported Webinars Supported Live Online Supported In Person Supported
Company Information SimplerQMS Founded: 2017 Denmark www.simplerqms.com	Company Information Lean & Mean Business Systems Founded: 2001 United States www.tlm-software.com
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Categories Audit Supported CAPA Supported Compliance Supported Document Control Supported Electronic Batch Records (EBR) Supported ISO Compliance Supported Medical Quality Management Systems Supported Quality Management Supported	Categories Audit Supported Calibration Management Supported CAPA Supported Document Control Supported Employee Feedback Supported FMEA Supported ISO Compliance Supported Manufacturing Supported Medical Quality Management Systems Supported Purchase Order Supported Quality Management Supported Risk Management Supported
Audit Features Alerts / Notifications Supported Audit Planning Supported Compliance Management Supported Dashboard Supported Exceptions Management Not Supported Forms Management Supported Issue Management Supported Mobile Access Supported Multi-Year Planning Not Supported Risk Assessment Supported Workflow Management Supported CAPA Features Audit Management Supported CAPA Planning Supported Change Management Supported Complaint Management Supported Incident Management Supported Nonconformance Tracking Supported Quality Control Supported Risk Management Supported Root Cause Analysis Not Supported Training Management Supported Document Control Features Archiving & Retention Supported Automated Routing Supported Change Management Supported Compliance Management Supported Electronic Signature Supported Escalation Management Supported Periodic Review Supported Version Control Supported Quality Management Features Audit Management Supported Complaint Management Supported Compliance Management Supported Corrective and Preventive Actions (CAPA) Supported Defect Tracking Supported Document Control Supported Equipment Management Supported ISO Standards Management Supported Maintenance Management Supported Risk Management Supported Supplier Quality Control Supported Training Management Supported Show More Features Compliance Features Archiving & Retention Supported Artificial Intelligence (AI) Not Supported Audit Management Supported Compliance Tracking Not Supported Controls Testing Not Supported Environmental Compliance Not Supported FDA Compliance Supported HIPAA Compliance Supported Incident Management Not Supported ISO Compliance Supported OSHA Compliance Not Supported Risk Management Supported Sarbanes-Oxley Compliance Not Supported Surveys & Feedback Not Supported Version Control Supported Workflow / Process Automation Supported	Audit Features Alerts / Notifications Supported Audit Planning Supported Compliance Management Supported Dashboard Supported Exceptions Management Supported Forms Management Supported Issue Management Supported Mobile Access Supported Multi-Year Planning Supported Risk Assessment Supported Workflow Management Not Supported Document Control Features Archiving & Retention Supported Automated Routing Supported Change Management Supported Compliance Management Supported Electronic Signature Supported Escalation Management Supported Periodic Review Supported Version Control Supported Quality Management Features Audit Management Supported Complaint Management Supported Compliance Management Supported Corrective and Preventive Actions (CAPA) Supported Defect Tracking Supported Document Control Supported Equipment Management Supported ISO Standards Management Supported Maintenance Management Supported Risk Management Supported Supplier Quality Control Supported Training Management Supported Show More Features Calibration Management Features Calibration Instructions Supported Calibration Schedules Supported Compliance Management Supported Device History Supported Due Date Tracking Supported Gage Management Not Supported Label Printing Not Supported Measurement Readings Supported Multi-Station Management Not Supported Out-of-Tolerance Notification Not Supported Statistical Data Reporting Not Supported Manufacturing Features Accounting Integration Supported ERP Supported Maintenance Management Supported MES Not Supported MRP Supported Purchase Order Management Supported Quality Management Supported Quotes/Estimates Supported Reporting/Analytics Supported Safety Management Supported Shipping Management Not Supported Risk Management Features Alerts/Notifications Supported Auditing Supported Business Process Control Supported Compliance Management Supported Corrective Actions (CAPA) Supported Dashboard Supported Exceptions Management Supported Internal Controls Management Supported IT Risk Management Supported Legal Risk Management Not Supported Mobile Access Supported Operational Risk Management Not Supported Predictive Analytics Not Supported Reputation Risk Management Not Supported Response Management Supported Risk Assessment Supported
Integrations Epicor Advanced MES Not Supported Epicor Kinetic Not Supported Microsoft 365 Supported Microsoft Dynamics 365 Not Supported Microsoft Entra ID Supported Microsoft Outlook Not Supported QuickBooks Enterprise Not Supported Zoho CRM Plus Not Supported View All 2 Integrations	Integrations Epicor Advanced MES Supported Epicor Kinetic Supported Microsoft 365 Not Supported Microsoft Dynamics 365 Supported Microsoft Entra ID Not Supported Microsoft Outlook Supported QuickBooks Enterprise Supported Zoho CRM Plus Supported View All 6 Integrations
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