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Standard Compliance For Different Industries

“There are few, if any, better choices than TLM for a company who wants to support their business with digital workflows across a wide variety of integrated data needs at an entry level price point.”

- Gord Wehner
Director, Quality Assurance & Regulatory Affairs, Northern Digital Inc.

Medical Device Companies (ISO 13485 and 14971)

Whether it’s spinal screws or diagnostic tools, TLM medical device customers love the fact that TLM comes complete with solutions that meet the requirements of ISO 13485, ISO 14971, the MDSAP, FDA 21 CFR Part 11/820, ISO 31000 and more!

Dedicated system settings for the medical device industry ensures their specific needs are met such as managing the DHF (Design History File), DMR (Device Master Record), or the DHR (Device History Record).

Everything you need from document management, customer complaints, design control, product lifecycle management, and bill of materials is available to optimize your QMS from the very beginning.


Prototype to Production

TLM is hands down the best option for a small start up team to leverage their initial resources and build electronic compliance from the beginning without taking valuable resources away from R&D efforts.   From concept, planning, design, validation, product launch, and post market surveillance, TLM has all the bases covered.

Single Source of Truth

Manage the entire life cycle of your device with an integrated framework that complies with FDA QSR and ISO 13485:2016 out of the box so that your quality management system can help you define user needs and get your device to market faster, cost effectively, with less risk.

Manufacturing or Service Industries (ISO 9001)
Regardless of industry, your quality management system provides critical risk management by addressing the root causes of many failures that ultimately result in unhappy customers. When used as Total Lean Management software, your QMS also plays a critical role in the overall management and leadership dynamics within your organization. TLM has everything you need to meet the requirements of ISO 9001 and establish through best practice workflows that you are capable of meeting your customer’s requirements.
Automotive Manufactures (IATF 16949)

If your company is in the automotive supply chain and feeling the pressure from customers to implement a compliant or registered quality system, you are in the right place.

TLM provides all the systems you need for compliance with IATF 16949 to include FMEA, 8D, integrated Control Plans, PPAP, and other automotive industry specific quality management system work flows that are easy to implement for companies further down in the automotive supply chain, to include robust systems for managing your own suppliers.

Insurance Industries

Did you know the custom field system allows you to rename modules and make other field description changes that gives TLM the ability to serve multiple industries? With a few small adjustments, Customer Feedback turns into a Claims Management system integrated with Purchase Orders that can be renamed to Payments. The Electronic forms module allows the processing and approval of various risk related documents and reporting tools gives management real time access to compare claim activities with budgets and much more!

Financial Industries (ADKAR)

Does your organization struggle with organizational change management projects?  TLM has a complete solution that allows your company to integrate your Prosci ADKAR® Model based projects using your company’s QMS system.

This includes support for all five outcomes an individual needs to achieve for a change to be successful: Awareness, Desire, Knowledge, Ability and Reinforcement.

TLM takes this module one step further and let’s you manage related activities with data specific to your company to include:

  • Project Management
  • Customizable checklists and action plans
  • Assignments by Department
  • Employee Surveys
  • Links to Training
  • Links to affected Procedures
  • Reviews and Approvals from the Companion Web App
  • And more!
Food Safety Compliance (HACCP, SQF, ISO/FSSC 22000, GFSI, FDA CFR 820)

Total Lean Management software can provide your company an all-in-one HACCP quality management system with real time critical control point monitoring using the TLM Companion Web App.

Management Responsibility

HACCP: Subpart B 820.20

Meetings &Reviews

Quality Audit

HACCP: Subpart B 820.22

Quality Audits

Personnel

HACCP: Subpart B 820.25

Employee Training

Design Controls

HACCP: Subpart C 820.30

DesignControl (PLM/ECR/FMEA/Control Plans/Inspection Templates)

Document Controls

HACCP: Subpart D 820.40

Document Management

Purchasing Controls

HACCP: Subpart E 820.50

Purchasing

Supplier Evaluations

Production & Process Controls

HACCP: Subpart G 820.70

In-process(CCP) Inspections

Measuring & Testing

HACCP: Subpart  G 820.72

Equipment Calibration/CMMS

Nonconforming Products

HACCP: Subpart I 820.90

Return Material (RMAs)

Corrective & Preventive Actions

HACCP: Subpart J 820.100

Corrective Actions (CAPA)

Inspections

HACCP: Subpart G 820.72

Inspections 

Customer Complaint Files

HACCP: Subpart M 820.198

Customer Feedback

There is Only One Type of Quality Management System

YOURS!

Over the last 20 years TLM has discovered a very basic truth when it comes to information management systems such as your eQMS, no two companies have the exact same needs.

In fact, the two biggest risks in the software selection process is either selecting software that is not flexible enough to manage information that is unique, and important to your workflow, thus forcing work arounds, or other concessions that effectively add waste to your business.

The other mistake is getting stuck with comprehensive, but inflexible systems due to their web based cloud hosting design, which forces a one size fits all approach to meeting customer needs.

And while one size might fit some, it might not fit all your needs when in the long run your understanding of those needs evolves and improves.

Total Lean Management Software, by definition, recognizes this fact, and addresses it through a dual technology, upstream / downstream user landscape approach to meeting the needs of both your upstream and downstream user types.  This is combined with our tiered approach to addressing newly discovered customer needs, making sure the software works in alignment with your business systems the day after your purchase, and for all the years ahead.

These measures include:

Custom fields

Allows you to adapt the software to your company’s terminology.

System Settings

Allows you to choose which features are applied to your process.

Rapid update cycles

Incorporating employee feedback into the continuous improvement cycle creates a synergistic effect on moral, engagement, and productivity.

Development Projects

This capability provides insurance that your system will never leave you stuck after discovering unknown needs after implementation.

High levels of interlinking

By implementing and combining modules in way that might be unique to your business or work flows.

World class customer support

Evolution is a team effort, and the whole team behind TLM enjoys helping companies comply with regulations, manage risk, continuously improve, and maintain a steady growth rate.

Help Files can be Linked to your Controlled Work Instructions

This unique TLM feature allows you to link individual screens in TLM to your own controlled procedures or work instructions for that area of the software (if needed).

Why TLM is your Best QMS Software Choice

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Our QMS Software is backed by a 100% success rate for ISO Certification On The First Try!

If you have any questions or want more detailed information, do not hesitate to call us.

If you have any questions or want more detailed information, do not hesitate to call us (866) 209-6896.

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Watch Awesome Testimonials

TLM Customers are always our top priority -David Smithstein, CEO

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“In the 10 years that we have relied on TLM to manage our quality documents, it has grown to become the core of our QMS. Our QMS has been audited by BSI, TUV, SAI, FDA, Canada Health and CDPH . We survived all of those audits and emerged a better company. Thanks, David!”

Jim Klett

★ ★ ★ ★ ★
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“EXCELLENT customer service! Without fail, David has responded to every question, email and phone call within a few hours. He is great to work with and always willing to help… TLM is a one-stop shop for all of our QMS needs … The training videos on the website are helpful- keep them coming!”

Allison Getz

★ ★ ★ ★ ★
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“Very helpful in fine-tuning the software/reports to meet our specific needs for audits, even ones requested the day before the audit. The software is straight forward for use, we have 8 personnel in two different locations using it seamlessly … The best customer support I have ever used.”

Stewart Denham

★ ★ ★ ★ ★

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