Qualio
Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness.
Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards.
Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams.
Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations.
The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.
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Windocks
Windocks provides on-demand Oracle, SQL Server, as well as other databases that can be customized for Dev, Test, Reporting, ML, DevOps, and DevOps. Windocks database orchestration allows for code-free end to end automated delivery. This includes masking, synthetic data, Git operations and access controls, as well as secrets management. Databases can be delivered to conventional instances, Kubernetes or Docker containers.
Windocks can be installed on standard Linux or Windows servers in minutes. It can also run on any public cloud infrastructure or on-premise infrastructure. One VM can host up 50 concurrent database environments. When combined with Docker containers, enterprises often see a 5:1 reduction of lower-level database VMs.
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Dialog
Dialog provides a comprehensive, modular solution for pharmacovigilance literature monitoring, designed to enhance the efficiency of organizations responsible for drug safety reporting by automating and refining the entire process of literature triage. With access to over 140 reputable scientific and medical literature databases, including MEDLINE, Embase, and Biosis, it standardizes the content from various sources, ensuring a consistent approach to precision search, deduplication, and structured XML output. The DialogML engine utilizes advanced artificial intelligence to prioritize search results based on their relevance to patient safety, identifies critical safety concepts, and categorizes references pertinent to ICSRs (Individual Case Safety Reporting), aggregated reports (PBRER, PSUR, DSUR), and safety signals, enabling reviewers to swiftly pinpoint high-priority articles. Furthermore, the Dialog Alerts Manager enhances the process of creating and managing alerts by providing features such as bulk editing options, comprehensive audit trails for changes in search strategies, flexible scheduling, and detailed tracking of delivery histories. This integrated system significantly reduces the time and effort required for effective literature monitoring, empowering organizations to focus more on critical drug safety issues.
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Compier Literature Screening
Compier Literature Screening is an AI-powered platform aimed at helping pharmacovigilance experts streamline the process of reviewing abstracts, full texts, and translated articles to uncover pertinent information about patients, authors, events, products, and safety-related data. This innovative platform seamlessly connects with various online biomedical databases, including Medline, and allows users to upload literature records in bulk from multiple sources like Embase, conference presentations, and PDF journals. It conducts automated duplicate checks for every literature search and employs validated AI models for the automatic screening and annotation of key entities. Users have the flexibility to set up scalable literature screening workflows that meet their unique needs and comply with international regulations. The system enhances collaboration with external vendors to secure full texts and comes equipped with translation capabilities. Additionally, it integrates smoothly with safety systems, such as Oracle Argus Safety, to share articles relevant to Individual Case Safety Reports (ICSRs), thereby ensuring comprehensive safety monitoring. The platform ultimately seeks to improve the overall efficiency and accuracy of pharmacovigilance activities.
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