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Alternatives to Consider
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RegDeskRegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies. • Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates. • With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time. • The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions. • Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners. • The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards. • Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators. To learn more about our offerings, please explore our website.
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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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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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SAP S/4HANA Cloud Public EditionSAP S/4HANA Public Cloud serves as an advanced ERP solution that facilitates rapid digital transformation through AI-driven insights, adherence to industry standards, and an intuitive user experience. By enhancing operational efficiency, empowering decision-making, and revealing new avenues for growth, it stands out as a comprehensive tool for modern businesses. Key features include compliance with SOX and GAAP, robust financial controls, detailed forecasting and reporting, and effective treasury and tax management. Additionally, it offers automation through AI, machine learning, and robotic process automation, alongside efficient supply chain and inventory management solutions. With templated integrations and strong manufacturing capabilities, it supports scalability for businesses of all sizes. Embracing industry innovation is essential to propel growth in revenue, efficiency, and profitability. Continuous improvement is the cornerstone of optimizing business operations and processes, ensuring that organizations stay competitive in their respective markets. Therefore, selecting a dedicated partner who is committed to your success is crucial in navigating this journey.
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QBenchQBench provides a comprehensive solution for monitoring all your samples and their positions within the workflow through a unified platform. By using QBench, you can forgo the traditional reliance on spreadsheets, shared network folders, and outdated paper tracking systems. The platform enables you to review numerous PDF reports and Certificates of Analysis (COAs) before finalizing or distributing them via email. You also have the option to create customizable barcodes and labels for your samples, ensuring compatibility with standard printers and scanners. Additionally, QBench features a billing module that streamlines the creation and dispatch of invoices directly from the system. Users can access data on counts and latencies for various data types within QBench, which encompasses metrics such as turnaround times, sample counts per test, delays, and more. This innovative tool simplifies the data collection process necessary for the assays conducted in your laboratory while enhancing overall efficiency. With QBench, managing your laboratory workflow has never been more straightforward and effective.
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Blackbird API DevelopmentStreamline the creation of production-ready APIs with ease. With advanced features like AI-driven code generation, quick mocking, and on-demand temporary testing setups, Blackbird offers a comprehensive solution. Utilizing Blackbird's unique technology and user-friendly tools, you can quickly define, mock, and generate boilerplate code. Collaborate with your team to validate specifications, execute tests in a real-time environment, and troubleshoot issues seamlessly within the Blackbird platform. This empowers you to confidently launch your API. You can manage your testing environment on your own terms, whether on your local device or through the dedicated Blackbird Development Environment, which is always accessible through your account without incurring any cloud expenses. In mere seconds, OpenAPI-compliant specifications are generated, allowing you to dive into coding without the hassle of design delays. Furthermore, dynamic and easily shareable mocking features eliminate the need for tedious manual coding or upkeep. Validate your process and proceed with confidence. Enjoy a more efficient workflow that accelerates your development cycle and enhances collaboration across teams.
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EHS HeroMeet EHS Hero, your comprehensive tool for managing risk, safety, emergency planning, compliance, and audit processes effectively. Our platform features an extensive suite of EHS management resources designed to optimize workflows and adhere to both federal and state regulations seamlessly. With integrated tools crafted by our skilled in-house professionals, we offer essential support that enables you to develop and execute straightforward training sessions and robust plans. Moreover, our automated workflow solutions deliver performance insights that facilitate the identification of improvement opportunities and the monitoring of progress over time. No matter if you are a small enterprise or a large corporation, EHS Hero provides flexible solutions tailored to your specific requirements. Its user-friendly interface ensures that even the most experienced employees can navigate the platform with ease. We handle all the challenging tasks, such as data migration, system configuration, and employee training, ensuring a smooth transition and quick operational readiness. Discover the exceptional benefits of our top-tier EHS management and compliance system, and take your organization's safety and regulatory adherence to the next level. With EHS Hero, you can confidently manage your environmental, health, and safety responsibilities while focusing on your core business objectives.
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ManageArtworksManageArtworks offers a purpose-built packaging artwork management platform that simplifies complex workflows and improves collaboration across marketing, regulatory, quality assurance, and packaging teams. It centralizes asset storage with advanced metadata management and robust version control to ensure teams always work on the latest files. The platform’s AI-powered proofing tools automate critical quality checks, including pixel-by-pixel image comparisons, font size verification, barcode scanning, and spell checking, dramatically reducing costly errors. Users benefit from a comprehensive dieline repository featuring over 3,000 customizable templates and the ability to visualize packaging in interactive 3D, helping catch issues early. Integration with Adobe Illustrator and InDesign streamlines content import directly into design files, eliminating time-consuming copy-pasting mistakes. ManageArtworks tracks every packaging change with detailed audit trails, ensuring compliance with regulatory standards like FDA 21 CFR Part 11 and EU Annex 11. Security is paramount, with support for SSO through providers like Azure AD and Okta, alongside ISO 27001 and SOC 2 Type 2 certifications. Leading brands such as Amul, P&G, and Nivea use ManageArtworks to reduce approval cycle times by up to 80% and improve first-time-right rates. The platform empowers teams to launch products faster with complete transparency and accountability across all stages of packaging development. Its user-friendly interface and end-to-end workflow management make packaging artwork creation efficient, accurate, and cost-effective.
What is Kalypso Accel for RIM?
Kalypso provides an economical option for life sciences companies aiming to adopt a Regulatory Information Management (RIM) system called Accel for RIM. This innovative platform supports a cohesive strategy for efficiently managing and overseeing product registrations, while also improving submission accuracy and handling global Unique Device Identification (UDI) details, which helps in optimizing product distribution. Furthermore, it integrates compliance and quality data from various enterprise systems into a single, reliable source for tracking product registrations, thus speeding up the regulatory submission process. By leveraging modern APIs, the system compiles product information along with essential regulatory documents and submission packages. Designed for quick implementation, it is based on a validated software framework that incorporates industry best practices and proven successful deployments. Companies that implement this solution can anticipate not only increased operational efficiency but also a notable decrease in the time required for regulatory activities. Additionally, this streamlined approach can significantly enhance organizational productivity and focus on strategic initiatives.
What is Accruent Meridian?
Our cutting-edge document management software stands out as a leader in its field. Meridian provides a unified source of truth and customizable workflows that enhance collaboration across various departments. It guarantees that every modification to a document is meticulously versioned, audited, and reported to meet regulatory standards. In the context of the architecture, engineering, and construction (AEC) industries, engineering document management involves the organization and oversight of complex documents such as CAD files, technical specifications, and correspondence. Companies operating in these sectors often face significant challenges when it comes to effectively managing their engineering documentation. Meridian's specialized software is designed to tackle these issues head-on, allowing for the centralization of documents and drawings within an organization while streamlining essential processes through automation. By leveraging Meridian, businesses can enhance efficiency and ensure compliance throughout their engineering projects.
Integrations Supported
Additional information not provided
Integrations Supported
Additional information not provided
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
Kalypso
Date Founded
2004
Company Location
United States
Company Website
kalypso.com/industries/life-sciences/digital-regulatory-information-management/
Company Facts
Organization Name
Accruent
Date Founded
1995
Company Location
United States
Company Website
www.accruent.com/solutions/engineering-document-management-meridian
Categories and Features
Categories and Features
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