ProcEdge RIMS vs. Kalypso Accel for RIM

RegDesk 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.

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.

Epsilon3 is the leading AI-powered procedure and resource management tool designed for teams building, testing, and operating advanced products and systems. ✔ Save Time & Money Avoid costly delays, mistakes, and inefficiencies by automatically tracking procedures and resources. ✔ Prevent Failures Ensure the right step is completed at the right time with conditional logic and built-in revision control. ✔ Optimize Collaboration Real-time progress updates and role-based sign-offs keep your stakeholders on the same page. ✔ Continuously Improve Advanced data analytics and automated reporting enable rapid iteration and data-driven decisions. Epsilon3 is trusted by industry leaders like NASA, Blue Origin, Firefly Aerospace, Sierra Space, Redwire, Shift4, AeroVironment, Commonwealth Fusion Systems, and other commercial and government organizations.

flowdit significantly boosts efficiency by automating routine responsibilities and minimizing errors, thereby fostering a connected atmosphere that improves employee productivity. It plays a vital role in adhering to regulatory requirements while simplifying audits and inspections, ultimately contributing to increased profitability for leading companies in various sectors. As a tailored solution designed for connected workers, flowdit shines in fields such as commissioning, quality control, maintenance, and environmental health and safety management. It facilitates seamless communication and teamwork across departments, allowing for ongoing process supervision that helps to detect and alleviate risks proactively. Additionally, the platform leverages AI-powered insights to preserve the integrity of documentation and enforce standard operating procedures, keeping operations smooth and minimizing mistakes. In the context of digital transformation, flowdit supports the digitization of inspection and auditing tasks, maintenance timelines, safety protocols, and environmental assessments, effortlessly integrating with IoT and ERP technologies. This integration not only bolsters operational safety but also ensures effective oversight of numerous sites, making it an invaluable asset for organizations aiming to thrive in a technologically advanced landscape. Furthermore, flowdit's capabilities empower teams to focus on strategic initiatives, ultimately driving innovation and growth.

ManageArtworks 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.

FusionAuth is a comprehensive authentication and authorization platform purpose-built for modern development teams and IT departments. Designed for seamless integration, it supports virtually any application stack or programming language. Every capability is fully exposed via APIs, giving your team the flexibility to address complex identity and access management (IAM) requirements without compromise. From core features like user registration and login, to advanced protocols such as passwordless authentication, MFA, SAML, and OIDC — FusionAuth delivers enterprise-level functionality out of the box. Built-in compliance tools make it easy to align with regulatory standards including GDPR, HIPAA, and COPPA, reducing risk and accelerating deployment. FusionAuth offers total deployment freedom: run it on any OS, in containers, in your private cloud, or choose FusionAuth Cloud — our fully managed, scalable SaaS hosting option. Whether you’re a startup or an enterprise, FusionAuth empowers your organization to customize and scale your identity infrastructure with confidence and control.

Proton Drive is a secure cloud storage and collaboration platform built for professionals who manage sensitive data. Whether you’re sharing internal documents, legal contracts, or client files, Proton Drive keeps your data private — by default. Files are encrypted on your device before upload, and only you and your collaborators can access them. Even Proton can’t read your files. You can set passwords, add expiration dates, or revoke access instantly — so you’re always in control. Each user gets 1 TB of storage, with the flexibility to add more as your team or projects grow. Designed and hosted in Switzerland, Proton Drive is developed by the team behind Proton Mail and Proton VPN — trusted by over 100 million users worldwide. We’re independent, open source, and committed to keeping your data safe from surveillance and vendor lock-in. Proton Drive helps you stay compliant, with support for: - GDPR, HIPAA, ISO 27001, NIS2, and DORA - Verified SOC 2 Type II audits - No complex setup. No third-party tools required. Built for security teams, law firms, healthcare providers, consultancies, and privacy-conscious organizations of all sizes.

WorkBright revolutionizes the hiring process by eliminating obstacles, allowing you to onboard new employees up to eight times quicker while ensuring security and precision are never sacrificed. What sets WorkBright apart from the competition? 𝗨𝘀𝗲𝗿-𝗳𝗶𝗿𝘀𝘁 𝗘𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 - Forget about complicated interfaces; WorkBright offers straightforward and user-friendly tools for both new hires and hiring managers. 𝗜𝗻𝗰𝗹𝘂𝘀𝗶𝘃𝗲 𝗛𝗶𝗿𝗶𝗻𝗴 - Accessible on any device and from any location, featuring a vision-impaired mode and workflows for preparer translation. 𝗦𝘂𝗽𝗲𝗿 𝗜-𝟵 𝗦𝗲𝗰𝘁𝗶𝗼𝗻 𝟮 - Ditch the costly $100 notary services; their geo-validated document inspection is more convenient, entirely compliant, and costs less than $20 per I-9. 𝗠𝗮𝗱𝗲 𝗳𝗼𝗿 𝗠𝗼𝗯𝗶𝗹𝗲 - A remarkable 80% of employees complete their paperwork effortlessly on their smartphones. 𝗙𝘂𝗹𝗹𝘆-𝗜𝗻𝗱𝗲𝗺𝗻𝗶𝗳𝗶𝗲𝗱 𝗜-𝟵 - WorkBright assures that their remote HR platform adheres to US hiring regulations, or they will cover the costs in the event of an audit. 𝗭𝗘𝗥𝗢 𝗔𝘂𝗱𝗶𝘁 𝗙𝗶𝗻𝗲𝘀 - They have successfully assisted over a million individuals in completing Form I-9 without incurring any employer penalties, maintaining an impeccable record they strive to uphold. 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗲𝗱 𝗕 𝗖𝗼𝗿𝗽 - WorkBright has achieved certification that reflects the highest standards of transparency and accountability in its operations, further reinforcing its commitment to excellence.

Process Street is the Compliance Operations Platform that helps fast-moving teams in regulated industries enforce standards, automate execution, and prove compliance with confidence. It brings document control, workflow automation, and real-time oversight into one unified platform so policies are not just written, they are followed and verified. With Process Street, teams can create version-controlled SOPs and policies using Pages, link them directly to automated workflows, and ensure every task, approval, and data point is tracked with audit-ready logs. Cora, the AI compliance agent, monitors execution in real time, flags issues, and recommends improvements, turning manual oversight into continuous control. Whether you need to onboard employees, prepare for audits, manage policy changes, or enforce vendor compliance, Process Street gives you the tools to do it faster and without the risk of missed steps or tribal execution. Automate form collection, task assignments, escalations, and approvals with no code. Keep teams aligned, even as you scale. Used across financial services, real estate, healthcare, and manufacturing, Process Street supports compliance with standards like ISO 9001, SOC 2, SOX, HIPAA, and FDA CFR Part 11. Thousands of teams at companies like Salesforce, Colliers, Hartford Healthcare, and Drift use Process Street to reduce audit prep time, streamline training, and build systems that run without micromanagement. Every workflow is structured. Every policy is enforced. Every action is proven. With native integrations, role-based access, automated evidence capture, and AI-powered insights, Process Street replaces checklists, spreadsheets, and siloed tools with a closed-loop system of control. If you run high-stakes processes and need to stay compliant without slowing down, Process Street is built for you.

Interfacing's Digital Twin Organization software enhances transparency and governance, which in turn boosts quality, efficiency, and ensures adherence to regulatory standards. This comprehensive platform enables users to map, analyze, and automate their workflows while effectively managing compliance and evaluating risks. The Enterprise Process Center (EPC) serves as an enterprise management solution that empowers businesses to digitally evolve their operations, facilitating streamlined processes, heightened productivity, and improved overall efficiency. Additionally, Interfacing's Rapid Application Development Tools (RAD), utilizing a Low Code Development approach, optimize your technical assets and enhance transparency, paving the way for ongoing improvements. Experience the power of our Low-Code Rapid Application Development module, which equips you with the essential tools to swiftly create and deploy custom, scalable, and secure applications that are ready for mobile use, significantly reducing development time from months to mere days. With these innovative solutions, organizations can achieve remarkable agility and responsiveness in today’s fast-paced business landscape.