Ratings and Reviews 0 Ratings
Ratings and Reviews 0 Ratings
Alternatives to Consider
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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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StandardFusionStandardFusion offers a comprehensive Governance, Risk, and Compliance (GRC) solution tailored for technology-driven small and medium-sized businesses as well as enterprise information security teams. By consolidating all data into a single system of record, it removes the reliance on spreadsheets, enabling users to confidently identify, evaluate, manage, and monitor risks. The platform establishes audit-based processes as a standard practice, allowing for streamlined audits with straightforward access to necessary evidence. Organizations can effectively manage compliance across various standards, including ISO, SOC, NIST, HIPAA, GDPR, PCI-DSS, and FedRAMP. Furthermore, it provides a centralized location for handling all vendor and third-party risk assessments and security questionnaires. As either a cloud-based SaaS solution or an on-premise GRC platform, StandardFusion is designed to simplify information security compliance, making it both accessible and scalable to fit a company's evolving needs. This unified approach not only enhances efficiency but also strengthens overall security posture.
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OnspringDiscover the GRC software you've been searching for: Onspring. This adaptable, no-code, cloud-based platform has been recognized as the top choice for GRC delivery for five consecutive years. Effortlessly manage and disseminate information for informed decision-making regarding risks, keep track of risk assessments and remediation outcomes in real-time, and generate detailed reports with essential key performance indicators at the click of a button. Whether you're transitioning from a different platform or are new to GRC software, Onspring provides the technology, clarity, and customer-focused support necessary to help you achieve your objectives swiftly. With our ready-to-use solutions, you can get started in as little as 30 days. From SOC and SOX to NIST, ISO, CMMC, NERC, HIPAA, PCI, GDPR, and CCPA—whatever the regulation, framework, or standard, Onspring allows you to capture, test, and report on controls, as well as initiate remediation for identified risks. Users appreciate Onspring’s no-code platform, which empowers them to make adjustments instantly and create new workflows or reports independently in just minutes, without relying on IT or developers. When speed, adaptability, and efficiency are paramount, Onspring stands out as the top software solution available today, tailored to meet the diverse needs of its users.
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Lockbox LIMSA cloud-based Laboratory Information Management System (LIMS) is designed to oversee sample tracking, test outcomes, and inventory management specifically for life sciences research, industrial quality control laboratories, and biotechnology/next-generation sequencing applications. This comprehensive system provides essential regulatory compliance support for standards such as CLIA, HIPAA, Part 11, and ISO 17025, ensuring that laboratories operate within the necessary legal frameworks. The importance of quality, security, and traceability in managing samples cannot be overstated, as these factors play a pivotal role in a lab's effectiveness and reliability. Utilizing the Lockbox LIMS platform, laboratory professionals gain the ability to meticulously oversee their samples, offering complete transparency throughout the entire process, from initial accession to long-term preservation. Additionally, LIMS analysis encompasses far more than merely tracking outcomes; the Lockbox system features advanced multilayered sample storage capabilities and location management, allowing users to customize their laboratory's storage framework with diverse options that include rooms, storage units, shelves, racks, and boxes. This flexibility empowers labs to efficiently organize and access their samples, ultimately enhancing operational productivity and accuracy.
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Predict360Predict360, developed by 360factors, serves as a comprehensive risk and compliance management platform designed to streamline workflows and improve reporting for various financial institutions, including banks, credit unions, and insurance companies. This cloud-based SaaS solution consolidates essential components such as regulations, compliance management, risk assessments, controls, key risk indicators (KRIs), audits, policies, and training into one cohesive platform while offering powerful analytics and insights that help clients foresee risks and enhance compliance efforts. If your current Governance, Risk, and Compliance (GRC) system isn't equipped with an effective analytics and business intelligence tool for creating insightful reports for executives and board members, consider Lumify360 from 360factors. This predictive analytics platform can seamlessly integrate with any existing GRC, allowing you to maintain your workflow processes while equipping stakeholders with the timely reports and dashboards they require for informed decision-making. With these advanced tools at your disposal, you'll be better positioned to navigate the complexities of regulatory compliance and risk management.
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MRPeasyDiscover the perfect MRP solution designed specifically for small manufacturers! MRPeasy provides a cost-effective, intuitive, and cloud-based MRP system customized for the unique needs of small manufacturing enterprises. Easily convert customer orders into manufacturing orders, with the system handling the scheduling automatically. It efficiently manages inventory by booking items as needed, and can generate purchase orders if required. With real-time requirements in mind, MRPeasy offers both forward and backward scheduling options, while automated checks make certain that workers, workstations, and materials are readily available. Keep a detailed view of all your operations at any moment! Additionally, MRPeasy seamlessly integrates with leading accounting software like QuickBooks and Xero, as well as e-commerce platforms such as Shopify and WooCommerce, creating a comprehensive business management solution that fulfills all your operational needs. This integration not only enhances efficiency but also streamlines processes across various aspects of your business.
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Matrix RequirementsOptimize every phase of the development lifecycle with a versatile solution tailored for SxMD, allowing for effective management of design controls that span from initial requirements to compliance, all while ensuring comprehensive traceability to reduce risk. Accelerate innovation through a flexible item-based documentation strategy that caters to the intricate demands of even the most sophisticated SxMD products. Improve quality management by maintaining full traceability from design inputs to outputs with a specialized software platform that fosters collaborative quality practices across all departments. Take command of the shifting landscape of design, quality, and regulatory criteria while promoting team independence, ensuring your product reaches the market more swiftly. Achieve seamless integration across platforms with built-in connections to Jira, GitLab, GitHub, Azure DevOps, and more, while also utilizing our REST API to link all your essential tools effortlessly. This comprehensive approach empowers teams to not only adapt but thrive in a fast-paced development environment.
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Netwrix AuditorNetwrix Auditor is a visibility solution that empowers you to manage modifications, settings, and access across hybrid IT landscapes. Additionally, it alleviates the pressure of upcoming compliance audits. You can track all alterations in both your cloud and on-premises systems, encompassing Active Directory, Windows Servers, file storage, Exchange, VMware, and various databases. Simplifying your inventory and reporting processes is achievable, and you can effortlessly confirm that your access and identity configurations align with the established good state by conducting regular reviews. This proactive approach not only enhances security but also boosts overall operational efficiency.
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TenForceMaking data accessible and actionable can be challenging in a manufacturing facility with numerous processes. As operations expand, adhering to safety, quality, and environmental regulations becomes increasingly complex. The manufacturing sector relies heavily on predictability and reliability, as success is rooted in the precise execution of established processes. TenForce was developed based on input from our clients to accurately reflect the operational realities within a plant, ensuring that businesses can navigate these complexities more effectively. By leveraging this feedback, TenForce aims to streamline operations and enhance compliance across the board.
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SatoriSatori is an innovative Data Security Platform (DSP) designed to facilitate self-service data access and analytics for businesses that rely heavily on data. Users of Satori benefit from a dedicated personal data portal, where they can effortlessly view and access all available datasets, resulting in a significant reduction in the time it takes for data consumers to obtain data from weeks to mere seconds. The platform smartly implements the necessary security and access policies, which helps to minimize the need for manual data engineering tasks. Through a single, centralized console, Satori effectively manages various aspects such as access control, permissions, security measures, and compliance regulations. Additionally, it continuously monitors and classifies sensitive information across all types of data storage—including databases, data lakes, and data warehouses—while dynamically tracking how data is utilized and enforcing applicable security policies. As a result, Satori empowers organizations to scale their data usage throughout the enterprise, all while ensuring adherence to stringent data security and compliance standards, fostering a culture of data-driven decision-making.
What is Qualio?
Qualio serves as a comprehensive platform for managing quality and compliance needs, making it particularly suitable for expanding businesses in the healthcare and life sciences sectors. Not only is Qualio dependable and cost-effective, but it also boasts a user-friendly interface. This innovative tool enables companies to accelerate the development of life-saving products while ensuring full compliance with ISO, GxP, and FDA standards. By centralizing functions such as document control, training, non-conformance reports (NCRs), audits, supplier management, and handling complaints, Qualio simplifies the operational processes for its users. This integrated approach allows organizations to focus on their core mission of improving health outcomes.
What is Ennov Pharmacovigilance Suite?
Ennov's Pharmacovigilance Suite provides a robust solution for the collection, management, assessment, and reporting of adverse events across both human and veterinary sectors, all housed within a unified database. The suite features advanced tools for signal detection and data analysis, ensuring compliance with international regulatory requirements. Key elements include optimized case intake and triage functionalities, improved user interfaces for data entry, customizable case input forms, and a wide array of searchable vocabulary lists. It supports multiple reporting formats, facilitating both paper and electronic submissions that adhere to CIOMS guidelines, MedWatch 3500s, and ICH E2B standards (R2 and R3). For signal detection and management, the platform provides comprehensive data querying capabilities, powerful analytical tools, and the ability to calculate important statistical metrics like PRR, ROR, and MGPS. Fully web-based and designed for ease of use, it complies with the standards set forth in 21 CFR Part 11, which ensures data integrity and security. Additionally, its flexible design allows it to cater to organizations of varying sizes, enabling users to adeptly manage the intricate landscape of pharmacovigilance while remaining responsive to evolving industry demands. This adaptability ensures that as organizations grow or change, the system remains a reliable resource throughout their pharmacovigilance journey.
Integrations Supported
Essenvia
Jira
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
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
Qualio
Date Founded
2010
Company Location
United States
Company Website
www.qualio.com
Company Facts
Organization Name
Ennov
Date Founded
1999
Company Location
France
Company Website
en.ennov.com/solutions/pharmacovigilance/
Categories and Features
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
Policy Management
Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management
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