Audience
Complex product companies including hi-tech, consumer electronics, and medical devices markets.
About Arena PLM
Arena PLM helps high-tech and medical device companies design, produce, and deliver innovative products quickly. Arena enables every participant throughout new product development (NPD) and new product introduction (NPI) to collaborate more effectively while ensuring regulatory compliance for FDA, ISO, ITAR, EAR, and environmental compliance.
Pricing
Starting Price:
contact vendor
Free Trial:
Free Trial available.
Company Information
Arena, a PTC Business
Founded: 2000
United States
www.arenasolutions.com
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QT9 QMS
QT9's comprehensive cloud-based quality management software platform enables you to access real-time analytics in one unified suite. QT9 QMS makes it easy to automate ISO & FDA Compliance with 21 CFR Part 11 Electronic Approvals. Optimize processes for Document Control, CAPA's, Audits & More in one unified platform.
Centralize records across multiple sites with ease. Never miss a deadline with automated email alerts/reminders. QT9 QMS makes quality management easy.
Digitally transform Life Sciences, Biotechnology, Medical Device Manufacturers, Pharma, Aerospace and Food companies with user-friendly web portals for unlimited scalability.
Get a free product tour! Start a Free 30-Day Trial. Visit QT9qms.com
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Total Lean Management (TLM) Software
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
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Dot Compliance QMS
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE!
Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances
✔ Seamless Install
✔ Cost Effective
✔ One-Stop-Shop
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SimplerQMS
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.
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Product Details
Platforms Supported
SaaS
Training
Documentation
Live Online
Webinars
In Person
Support
Phone Support
Online
Arena PLM Frequently Asked Questions
Arena PLM Product Features
Product Lifecycle Management
Change Management
Compliance Management
Cost Tracking
Design Management
Document Management
Product Data Management
Project Management
Requirements Management
Supplier Management
Arena PLM Reviews
Write a Review-
Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Best engineering support tool" Posted 2023-03-30
Pros: Imports electrical parts with a click.
Manages BOM releases and logistics, ECOs. Allows cost comparisons among BOM variants.
Manages project versioning and releases.
Manages project milestones.Cons: Expensive. We had to give it up. Learning curve is a little steep.
Overall: Very good. Perfect for large design teams with project releases involving milestones. We used it ever day to import parts into Altium and generate cost estimates for BOMs.
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