Ratings and Reviews 0 Ratings
Ratings and Reviews 0 Ratings
Alternatives to Consider
-
SBS Quality Management SoftwareThe SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency. 1) The SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance. 2) SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features. 3) SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management. 4) The SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations. 5) The SBS Vendor Management maintains an approved vendor list (AVL), formulates vendor qualification plans, and tracks the qualification history of suppliers. Each of these modules may be purchased individually or in any combination to meet your needs. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.
-
IntelexIntelex provides an integrated software solution designed to manage Environmental, Health, Safety, and Quality (EHSQ) initiatives effectively. Its versatile platform is engineered to gather, control, and analyze EHS and Quality data in a comprehensive manner. This solution is accessible on any device, aligning perfectly with the demands of your workplace. Utilizing Intelex allows your organization to: Enhance the results of your EHSQ program by overseeing workflows for improved performance and control. Identify trends and behaviors through effective goal-setting to enrich insights and enhance decision-making within your EHSQ framework. Reduce incidents and minimize administrative burdens by adeptly supervising, managing, refining, and deriving insights from your safety data with our user-friendly safety software. Streamline the management and reporting of air, water, and waste emissions while overseeing environmental outputs to achieve sustainability goals. Encourage continuous quality improvements by effortlessly recording and tracking all instances of nonconformity within a centralized, web-based system, allowing for trend analysis across multiple departments or locations. Intelex also aids in navigating compliance with global standards and regulations like OSHA, WCB, ISO 45001, EPA, and ISO, fostering a culture of safety and accountability within your organization. By leveraging these tools, companies can not only comply with regulations but also drive long-term growth and sustainability.
-
QualioQualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
-
FlowlensSimple, smart software for SME manufacturers. Flowlens delivers end-to-end business management software designed specifically to meet the needs of SME manufacturers. Use Flowlens to support your growth as you add customers, suppliers, stock and scale to your manufacturing business. With Flowlens, you can: • Centralize your business information in one secure, cloud-based system • Manage customers, suppliers, and inventory with complete visibility • Streamline production and capacity planning • Automatically identify stock shortages and create purchase orders • Handle multi-level BOMs and production routings with ease • Manage unlimited SKUs across your product lines • Maintain traceability and quality compliance • Control multi-site and multi-level stock operations • Deliver exceptional after-sales service with full product history • Integrate seamlessly with Xero, QuickBooks Online, and Sage 50  Optimise productivity. Whether you’re looking to replace paper and Excel based processes or older legacy systems, implementing Flowlens provides you with a proven pathway to boosting profitability and establishing data integration across your business functions.  Deliver financial visibility across your supply chain. Connect Flowlens with your accounting applications, and you’ll remove data double entry between functions and establish full online reporting visibility across all your operations.  Enhance stock control. Pinpoint your near and long term materials requirements through Flowlens capacity planning and multi-level BOM management.  Drive supplier management. Move your supplier management processes online with Flowlens. Simplify and streamline supplier negotiations and maximise your cost and quality position through Flowlens RFQ management functionality. Speak to our implementation staff today to agree an action plan that meets your goals for enhanced productivity, increased data integration and improved profitability.
-
Interfacing Integrated Management System (IMS)Interfacing’s IMS is an AI-enabled platform that combines business process modeling, quality management, controlled documentation, and governance/risk capabilities in a single hub. Organizations rely on IMS to document and automate workflows, maintain versioned records, manage risk programs, and keep compliance activities aligned with regulatory requirements through full lifecycle traceability. Developed for industries where accountability and oversight are essential, including aerospace, pharma/biotech, finance, and government, IMS delivers operational insight, workflow automation, and intelligent recommendations that help reduce risk and improve quality outcomes. The platform holds ISO 27001 certification and includes 21 CFR Part 11 validation, supporting secure use in high-compliance environments. Additional capabilities include low-code app creation, AI-based process mining, audit management, CAPA and training modules, and performance dashboards. AI improves governance accuracy, strengthens compliance posture, and supports ongoing improvement.
-
Certainty SoftwareCertainty is a comprehensive software solution for auditing and inspection that offers reliable support in managing and reporting on business risks, compliance, and performance indicators swiftly and effectively. Utilized by countless professionals, Certainty Software facilitates millions of inspections and audits annually, equipping users with essential tools to gather, organize, and present precise, consistent, and actionable metrics throughout the organization. In addition to its data management capabilities, Certainty empowers users to design, oversee, and report on inspection and audit findings while also assisting in the identification and mitigation of risks, incidents, and challenges that may arise during the auditing process. This software not only enhances operational efficiency but also ensures that businesses maintain high standards of accountability and performance.
-
QuickbaseTransforming your operations can be achieved by implementing workflows and ensuring real-time visibility, enabling your teams to adapt swiftly to change. To enhance insight and automation within intricate systems and processes, it's essential to integrate and connect data, workflows, and procedures effectively. This will allow you to quickly adjust your operations to seize new opportunities while also mitigating potential risks. Customizing workflows to align with the evolving needs of your workforce is crucial. You can develop new workflows in just days, instead of weeks, to tackle emerging challenges and support innovative work methods. Establish a connected, governed ecosystem of digital solutions designed to safeguard your most critical data and operational processes. By revolutionizing the way your data is utilized, you can empower your workforce to generate real-time insights through a cohesive platform. Unlock your team's full potential and enhance collaboration. Quickbase is now at your disposal, ready to propel your organization forward.
-
ReflectizReflectiz is a web exposure management platform that helps organizations identify, monitor, and mitigate security, privacy, and compliance risks across their online environments. It provides full visibility and control over first, third, and fourth-party components like scripts, trackers, and open-source libraries that traditional security tools often miss. What sets Reflectiz apart is its ability to operate remotely, without the need to embed code on customer websites. This ensures there’s no impact on site performance, no access to sensitive user data, and no additional attack surface. The platform continuously monitors all external components, providing real-time insights into the behaviors of third-party applications, trackers, and scripts that could introduce risks. By mapping your entire digital supply chain, Reflectiz uncovers hidden vulnerabilities that traditional security tools may overlook. Reflectiz offers a centralized dashboard that enables businesses to gain a comprehensive, real-time view of their web assets. It allows teams to define baselines for approved and unapproved behaviors, swiftly identifying deviations and potential threats. With Reflectiz, businesses can mitigate risks before they escalate, ensuring proactive security management. The platform is especially valuable for industries like eCommerce, finance, and healthcare, where managing third-party risks is a top priority. Reflectiz provides continuous monitoring and detailed insights into external components without requiring any modifications to website code, helping businesses ensure security, maintain compliance, and reduce attack surfaces. By offering deep visibility and control over external components, Reflectiz empowers organizations to safeguard their digital presence against evolving cyber threats, keeping security, privacy, and compliance top of mind.
-
Global Shop SolutionsWe simplify your manufacturing.â„¢ With AI in mind, Global Shop Solutions ERP software offers all the applications you need to run a leaner, more efficient manufacturing operation. From CRM, inventory management and agile project management, to job costing, scheduling, tracking and efficient quality management, every application you need is right at your fingertips.
-
DigitDigit is a cloud-based software solution designed to assist businesses in monitoring their operations in real-time. It encompasses various functionalities for purchasing, receiving, inventory management, production, sales, and fulfillment. The primary objective of Digit is to unify disparate systems into a comprehensive operating system that enables organizations to plan, execute, measure, optimize, and connect their processes effectively. With features that allow users to create purchase orders, manage serialized inventories, ensure quality control, handle material billing and routings, oversee sales order management, and facilitate guided picking and packaging, Digit streamlines numerous operational aspects. Additionally, it seamlessly integrates with QuickBooks, enhancing its utility for financial management. This innovative software provides a holistic approach, empowering businesses to enhance their efficiency and productivity.
What is FMEA-Pro?
Effectively managing quality risk poses a significant challenge in the absence of a robust knowledge management system. To overcome this obstacle, it is crucial to implement systems that can accurately identify, capture, manage, and share essential documents and information. Sphera’s FMEA-Pro software offers a versatile framework that supports various FMEA methodologies and includes specialized tools for handling risk data, which ensures that suitable controls are put in place. This software integrates critical quality information across both design and manufacturing processes, aiding organizations in meeting the quality expectations of their customers. Moreover, Sphera’s FMEA-Pro software enhances profitability by utilizing a standardized method to thoroughly assess inherent risks. Additionally, Sphera's enterprise Advanced Risk Assessment tool enables organizations to consistently identify, evaluate, and reduce the impact of operational risks. This comprehensive approach significantly bolsters overall operational efficiency and fosters resilience against potential challenges. Ultimately, integrating these innovative tools allows businesses to navigate complexities more effectively, leading to improved performance and customer satisfaction.
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.
Integrations Supported
Azure SQL Database
Microsoft 365
Sunday Business Systems
Integrations Supported
Azure SQL Database
Microsoft 365
Sunday Business Systems
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
$135.00/one-time
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
Sphera
Company Location
United States
Company Website
sphera.com/failure-mode-effects-analysis-software-fmea-pro/
Company Facts
Organization Name
Sunday Business Systems
Date Founded
2004
Company Location
United States
Company Website
sundaybizsys.com/fmea-database/
Categories and Features
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