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.
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.
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.
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.
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.
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!
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.
HACCP: Subpart B 820.20
HACCP: Subpart B 820.22
HACCP: Subpart B 820.25
HACCP: Subpart C 820.30
DesignControl (PLM/ECR/FMEA/Control Plans/Inspection Templates)
HACCP: Subpart D 820.40
HACCP: Subpart E 820.50
Production & Process Controls
HACCP: Subpart G 820.70
Measuring & Testing
HACCP: Subpart G 820.72
HACCP: Subpart I 820.90
Return Material (RMAs)
Corrective & Preventive Actions
HACCP: Subpart J 820.100
Corrective Actions (CAPA)
HACCP: Subpart G 820.72
Customer Complaint Files
HACCP: Subpart M 820.198
There is Only One Type of Quality Management System
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:
Allows you to adapt the software to your company’s terminology.
Allows you to choose which features are applied to your process.
Incorporating employee feedback into the continuous improvement cycle creates a synergistic effect on moral, engagement, and productivity.
This capability provides insurance that your system will never leave you stuck after discovering unknown needs after implementation.
By implementing and combining modules in way that might be unique to your business or work flows.
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.
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!
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