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What is FMEA Database?

Develop a straightforward and effective Quality Management System (QMS) which can be hosted on your local server or accessed via our Cloud QMS option. Adhering to ISO 9001:2015 mandates the incorporation of risk-based thinking. Conducting a Risk Assessment through Failure Modes and Effects Analysis (FMEA) is essential for implementing risk-based strategies aligned with ISO 9001 and ISO 14971. It is crucial to identify potential failure modes for every item or process, assess their effects and severity, determine the underlying causes and their frequency, and recognize existing controls along with their detection capabilities. A series of actions must be initiated in response to each identified failure mode, with clear assignment of ownership and due dates. Additionally, it is important to set up criteria for verification and validation, which can be approved by management through electronic signatures. User login protocols should include defined passwords and privilege levels, while a comprehensive suite of reports will facilitate tracking of unresolved actions and overdue tasks. Microsoft Access can be downloaded free of charge, and for deeper data analysis, the information can be exported to Excel. This system operates on a commonly used software platform that is both accessible and user-friendly, ensuring that organizations can maintain high standards of quality management effortlessly.

What is Ansys medini analyze?

Ansys medini analyze integrates key safety analysis methodologies such as HAZOP, HARA, FHA, FTA, and FME(C)A into a unified platform. This combination facilitates the effective and standardized application of analysis techniques required by safety regulations. As a model-based tool, Ansys medini analyze is tailored for safety evaluations in systems that depend significantly on electrical, electronic, and software controls. It guarantees consistent and efficient adherence to industry standards, including ISO 26262, IEC 61508, ARP 4761, ISO 21448, and MIL-STD-882E. By employing Ansys medini analyze, organizations can eliminate inconsistencies in functional safety assessments, which in turn streamlines the certification process. Users have indicated that the tool can reduce the workload and time needed for functional safety evaluations by as much as 50%, accelerating product launches. Furthermore, this solution not only improves the precision of safety analyses but also automates the evaluation tasks for electronic and software systems, enhancing overall productivity. In the end, Ansys medini analyze equips teams with the necessary tools to effectively navigate the stringent requirements of safety-critical sectors while fostering a culture of continuous improvement in safety practices.

Media

Media

Integrations Supported

Jama Connect

Integrations Supported

Jama Connect

API Availability

Has API

API Availability

Has API

Pricing Information

$135.00/one-time
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Sunday Business Systems

Date Founded

2004

Company Location

United States

Company Website

sundaybizsys.com/fmea-database/

Company Facts

Organization Name

Ansys

Date Founded

1970

Company Location

United States

Company Website

www.ansys.com/products/safety-analysis/ansys-medini-analyze

Categories and Features

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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