DXC RIM vs. APL nextED

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.

Pipefy is the Enterprise-Grade Business Orchestration and Automation Technologies (BOAT) platform. It serves as a central orchestration layer that connects people, AI agents, and legacy systems into a unified operation. While traditional BPM solutions require months of engineering and consulting to deploy, Pipefy is architected to deliver AI-driven results in days. This speed enables IT leaders to solve the "backlog crisis" and modernize operations without the high cost of changing ERPs. Why Enterprise IT chooses Pipefy: 1. Elimination of Shadow IT: Unsanctioned tools create security risks and data silos. Pipefy’s "Adaptive Governance" model allows IT to set strict guardrails ("Safe Zones"). This empowers business units to build their own workflows—reducing the IT ticket backlog—while Technology teams maintain full visibility and control over data security and architecture. 2. Legacy Modernization (Two-Speed IT): Pipefy extends the capabilities of rigid legacy stacks (Systems of Record). By acting as an agile "System of Engagement" on top of SAP, Oracle, or Mainframes, it allows companies to deploy modern digital experiences and complex process logic without touching the delicate core code. 3. Agentic AI & Automation: The Pipefy Agent Studio moves beyond simple chatbots. It enables the deployment of specialized AI agents capable of executing tasks, reading unstructured documents (IDP), and routing requests based on complex rules. It creates a "Human-in-the-Loop" environment where AI handles the volume, and humans handle the exceptions. 4. Proven Economic Impact: Verified by a Forrester TEI study, Pipefy delivers a 260% ROI and a payback period of less than 6 months. It allows organizations to process high volumes of service requests (HR, Finance, Procurement, CS) with greater accuracy and less manual overhead. Compliance: SOC2 Type II, ISO 27001, ISO 42001 (AI Management), and SSO (SAML/OIDC) ready.

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.

LendingPad is an enterprise-grade, cloud-based loan origination solution (LOS) crafted to advance mortgage lending for banks, credit unions, brokers, and lenders. Developed by seasoned mortgage experts, the system prioritizes rapid processing, transparency, and intuitive usability—empowering teams to expedite closings and enhance the borrower journey. This platform brings together essential workflows, streamlines repetitive processes, and upholds compliance using a robust, API-centric design. By minimizing operational slowdowns and making daily tasks easier, LendingPad lets mortgage professionals dedicate more time to client service rather than administrative duties. Its adaptable framework supports institutions of any size in responding swiftly to shifts in the market, regulatory updates, and new business strategies.

MedTrainer streamlines and enhances the education, compliance, and credentialing processes for the healthcare workforce. Its software platform is designed for optimal user interaction, enabling healthcare organizations to effectively manage their personnel. The learning management system (LMS) tailored for healthcare offers a wealth of educational courses and materials developed by experts, ensuring that organizations meet regulatory standards and accreditation needs while providing opportunities for continuing education credits. In terms of compliance, MedTrainer provides a comprehensive technology solution that integrates incident reporting, document management, and customizable reporting to bolster adherence to regulations. Additionally, its credentialing feature offers a complete solution with automation and organized workflows, making the entire process more efficient and minimizing delays. Every aspect, from primary source verification to provider enrollment and privileging, is consolidated on a single platform, allowing for full transparency and oversight throughout. With MedTrainer, healthcare organizations can significantly reduce the complexities associated with workforce management.

MOVEit Managed File Transfer (MFT) software is utilized by numerous organizations globally to enhance visibility and control over file transfer operations. It guarantees the robustness of essential business workflows while facilitating the secure and compliant exchange of sensitive information among customers, partners, users, and various systems. With its adaptable framework, MOVEit allows organizations to select the features that align with their specific requirements. MOVEit Transfer integrates all file transfer processes into a single platform, which enhances oversight of crucial business functions. The software offers strong security measures, centralized access controls, and file encryption, alongside comprehensive activity tracking, to maintain operational dependability and ensure adherence to regulatory standards, service level agreements, and internal governance policies. Additionally, MOVEit Automation complements MOVEit Transfer and FTP systems by introducing sophisticated workflow automation capabilities, eliminating the necessity for complex scripting. Ultimately, this comprehensive solution empowers organizations to optimize their file transfer processes while ensuring compliance and security.

Predict360, 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.

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.

Qualio 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.

JSCAPE offers a Platform Independent Managed File Transfer Server that serves as an excellent choice for government entities and corporations aiming to streamline their operations while ensuring secure, reliable, and efficient file transfers. It adheres to all necessary compliance standards such as SOX, PCI DSS, and HIPAA, making it a trustworthy option for sensitive data handling. By centralizing and managing file transfers, organizations can tackle various business challenges more effectively. The solution can be implemented in cloud, on-premises, or hybrid cloud settings, providing flexibility tailored to unique organizational needs. Business processes can be automated using triggers, eliminating the need for complex custom scripts. Furthermore, JSCAPE's mobile clients for iOS and Android facilitate easy file exchanges, while integration capabilities with Amazon and Google enhance regulatory compliance. The mobile user authentication system for both iOS and Android devices is designed to be both user-friendly and robust, ensuring security without sacrificing accessibility. With these versatile features, JSCAPE stands out as a comprehensive solution for modern file transfer requirements.