Arena PLM

Arena PLM

Arena by PTC
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About

Arena PLM is a cloud-native and helps high-tech, medical device, life science, and aerospace and defense companies design, produce, and deliver innovative products quickly. By unifying all product information in a single, secure source of truth, product teams can collaborate anytime, anywhere. Arena streamlines new product development (NPD) and new product introduction (NPI) processes while ensuring regulatory compliance for FDA, ISO, ITAR, EAR, and environmental compliance.

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.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

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

Audience

Complex product companies including hi-tech, consumer electronics, and medical devices markets.

Audience

Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Contact vendor
Free Version Not Supported
Free Trial Supported

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

Reviews/Ratings

Overall 4.0 / 5
ease 4.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

Reviews/Ratings

Overall 1.0 / 5
ease 1.0 / 5
features 1.0 / 5
design 1.0 / 5
support 2.0 / 5

Pros & Cons from Real Users

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.

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.

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

Arena by PTC
Founded: 2000
United States
www.arenasolutions.com

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

Alternatives

Propel

Propel

Propel Software

Alternatives

isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
QEdge

QEdge

Sarjen Systems Pvt Ltd
QualityPro by TecWork

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
Teamcenter

Teamcenter

Siemens
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

Audit Supported
CAPA Supported
Compliance Supported
Document Control Supported
ISO Compliance Supported
Quality Management Supported

Product Lifecycle Management Features

Change Management Supported
Compliance Management Supported
Cost Tracking Supported
Design Management Supported
Document Management Supported
Product Data Management Supported
Project Management Supported
Requirements Management Supported
Supplier 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

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

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

Integrations

1factory Manufacturing Quality Supported
Allegro X Design Platform Supported
Essenvia Supported
Expandable Supported
FlowEQ Supported
IdoSell Supported
Kenandy Supported
Leverage Supported
Manufacturo Supported
Microsoft Dynamics GP Supported
Microsoft Entra ID Not Supported
NetSuite Supported
OrCAD X Supported
Puntt AI Supported
Rimsys Supported
SAP ERP Supported
SOLIDWORKS Supported
Sage 300 Supported
Salesforce Supported
Zendesk Supported

Integrations

1factory Manufacturing Quality Not Supported
Allegro X Design Platform Not Supported
Essenvia Not Supported
Expandable Not Supported
FlowEQ Not Supported
IdoSell Not Supported
Kenandy Not Supported
Leverage Not Supported
Manufacturo Not Supported
Microsoft Dynamics GP Not Supported
Microsoft Entra ID Supported
NetSuite Not Supported
OrCAD X Not Supported
Puntt AI Not Supported
Rimsys Not Supported
SAP ERP Not Supported
SOLIDWORKS Not Supported
Sage 300 Not Supported
Salesforce Not Supported
Zendesk Not Supported
Claim Arena PLM and update features and information
Claim Arena PLM and update features and information
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