Ratings and Reviews 2 Ratings
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Adaptive Compliance Engine (ACE)The Adaptive Compliance Engine® (ACE®) is a versatile, workflow-driven eQMS/eDMS solution that can seamlessly adjust to various business processes, providing real-time oversight, management, and reporting for compliance, quality, and operational tasks. By utilizing ACE®, organizations can alleviate administrative burdens and enhance ROI through immediate productivity improvements, while maintaining adherence to 21 CFR Part 11 regulations. Our comprehensive software suite features: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And numerous additional capabilities! Enable every tier of your organization with user-friendly interfaces, effortlessly locate all documents and records, and convert your data into insightful intelligence through advanced analytics, all within one unified platform. Every essential application is bundled together at a single price with ACE, eliminating the need for separate purchases. Enjoy the convenience of one software solution with countless functionalities, making it a truly invaluable asset for your business.
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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.
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AizonAizon: Intelligent GxP Manufacturing Aizon delivers an AI-powered platform that redefines how pharmaceutical and biotech manufacturers operate under GxP requirements. Our solutions empower teams to enhance efficiency, raise yields, and maintain the highest standards of product quality. - Aizon Execute — Intelligent Batch Record (iBR): Digitize production quickly to reduce manual errors, lower deviations, and accelerate the release of compliant batches. - Aizon Unify — Contextualized Intelligent Lakehouse: Connect and contextualize data from diverse sources to improve decision-making and achieve operational excellence. - Aizon Predict — GxP AI Industrialization: Use predictive AI models to fine-tune critical process parameters, increase Right-First-Time outcomes, and deliver higher manufacturing performance. Aizon enables manufacturers to move beyond traditional compliance and embrace true operational intelligence—learning from the past, acting decisively in the present, and innovating for the future.
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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.
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Shoplogix Smart Factory PlatformGain immediate insights into the performance of your manufacturing floor with the Shoplogix smart factory platform, which empowers manufacturers to enhance overall equipment effectiveness, cut down operational expenses, and boost profitability. This platform enables real-time visualization, integration, and action on production and machine performance, making it a trusted ally for manufacturers aiming to enhance efficiency in their factories. By leveraging analytics and real-time visual data, you can gain crucial insights that facilitate well-informed decision-making. Uncover untapped potential on the shop floor to accelerate your time-to-value significantly. Through a commitment to education, training, and data-centric decisions, you can foster a culture of continuous improvement within your organization. Make the Shoplogix Smart Factory Platform the cornerstone of your digital transformation journey, allowing you to thrive in the competitive i4.0 landscape. Furthermore, streamline data collection and interoperability with various manufacturing technologies by connecting to any device or piece of equipment, ensuring a seamless flow of information. Automate the monitoring, reporting, and analysis of machine states to effortlessly track production in real-time, enhancing your operational capabilities even further. In doing so, you position your manufacturing processes for sustained growth and innovation.
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Katana Cloud InventoryThe Katana Cloud Inventory platform offers an integrated view of your business, featuring real-time inventory and manufacturing oversight, batch tracking for comprehensive traceability, a dedicated Shop Floor App for complete control at the manufacturing level, an open API for seamless integrations, and an expanding network of channel partners. With real-time inventory insights, you can access current data to make well-informed decisions, effectively avoiding issues like stockouts and overstocking. This ensures you maintain full visibility of product locations, arrivals, and quantities, which is crucial for operational efficiency and accurate stock management. The platform also includes built-in purchase order management, allowing businesses to make data-driven purchasing choices based on specific material needs and reorder thresholds. Users can generate purchase orders directly through Katana and monitor potential delays to fulfill customer demands promptly. In terms of manufacturing operations management, you can establish your bill of materials and processes to enhance production scheduling, balance raw material and finished goods levels, and keep a close eye on manufacturing costs for a more efficient production workflow. Moreover, the omnichannel sales management feature consolidates all your B2B and B2C sales orders, enabling quick identification of available items for sale, thereby significantly streamlining your order fulfillment process and enhancing overall operational effectiveness. This comprehensive approach not only drives efficiency but also supports sustainable growth in your business.
What is MasterControl?
Bringing innovative products to market in heavily regulated sectors often feels like an unending series of compromises. However, MasterControl's GxP software streamlines workflows, ensuring that you don't have to sacrifice quality for cost or innovation in the face of regulation.
With a perfect blend of completeness and connectivity, combined with a focus on flexibility and speed, MasterControl Quality Excellence turns quality data and processes into a significant competitive advantage.
The journey toward modernizing your manufacturing operations begins with advanced software solutions. MasterControl Manufacturing Excellence simplifies the digital transformation of manufacturing, covering everything from work orders and production records to logbooks and work instructions, making it the most straightforward approach to digitizing your manufacturing processes.
What is Dot Compliance QMS?
Dot Compliance has introduced the first ready-to-use Quality Management Solution integrated with the Salesforce.com platform. This innovative solution encompasses a comprehensive array of pre-configured eQMS and compliance processes, allowing clients to implement it swiftly and affordably. Included in the Dot Compliance offerings are complete project validation services alongside product validation packages. Their solution stands out as the most economical option for quality and compliance management in the industry, empowering users to deploy adaptable and scalable solutions without delay. Key quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, and Supplier Quality can be automated effortlessly. Furthermore, the solution is designed to be fully configurable and supports seamless integration, which makes it easy for customers to tailor the system to meet their unique specifications. By prioritizing user needs, Dot Compliance ensures a smooth transition and effective management of quality across various operations.
Integrations Supported
Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Res_Q
SAP Business ByDesign
Salesforce
Showpad Coach
VIPRE Security Awareness
Integrations Supported
Inspired eLearning HR & Compliance
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Res_Q
SAP Business ByDesign
Salesforce
Showpad Coach
VIPRE Security Awareness
API Availability
Has API
API Availability
Has API
Pricing Information
$25,000 / 1st year
Free Trial Offered?
Free Version
Pricing Information
$10,000 / Annually
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
MasterControl
Date Founded
1994
Company Location
United States
Company Website
www.mastercontrol.com
Company Facts
Organization Name
QMS for Life Sciences
Date Founded
2007
Company Location
United States
Company Website
www.dotcompliance.com
Categories and Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Change Management
Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management
Complaint Management
Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control
Document Version Control
Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback
EHS Management
Audit Management
Corrective / Preventive Actions
Environmental Management
Environmental Risk Assessment
Forms Management
Incident Management
Industrial Safety Management
Injury Reporting
Inspection Management
MSDS
OSHA Recordkeeping
Occupational Health Management
Safety Risk Assessment
Training Management
Waste Management
Manufacturing Execution
Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability
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
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
Safety Management
Audit Management
Corrective / Preventive Actions
Incident Management
Injury Reporting
Inspection Management
OSHA Recordkeeping
Safety Risk Assessment
Training Management
SPC
Corrective Actions (CAPA)
Data Entry
Data Linking
Data Management
Excel Loader
Job Management
OPC Data Collection
Performance Metrics
Point-of-Production Analysis
Real Time Data Collection
Regulatory Compliance
Work Instructions
Branding & Style Sheets
Content Management System
Drag and Drop
Dynamic Tags
Employee Feedback
Guide Approval Workflows
Media Editor
Multi-Brand Publishing
Rich Text Editor
SSO (SAML)
Translations
User Management
Version Control
Categories and Features
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Change Management
Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management
Complaint Management
Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control
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
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
SPC
Corrective Actions (CAPA)
Data Entry
Data Linking
Data Management
Excel Loader
Job Management
OPC Data Collection
Performance Metrics
Point-of-Production Analysis
Real Time Data Collection
Regulatory Compliance