TraceLink Integrations

Res_Q is an AI-powered GxP validation and compliance management platform developed by Sware for organizations operating in regulated life sciences environments. The software centralizes computerized system validation, documentation, risk assessments, testing, and approval workflows within a cloud-based platform. Its agentic AI capabilities automate routine validation activities, monitor progress, and identify milestones requiring human attention. Res_Q provides intelligent risk scoring, automated document processing, video-to-test-script generation, and dashboards for analyzing validation activities. The platform supports Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and AI system validation requirements. Integration capabilities connect Res_Q with enterprise applications, testing tools, and quality management systems while maintaining traceable records and audit trails.

Zelthy Regulatory Affairs is software for pharmaceutical and biotechnology regulatory teams managing submissions across health authorities and jurisdictions. It provides a consolidated view of submission pipelines, milestones, jurisdiction-specific requirements and health authority queries. Teams can organize regulatory dossiers, validate publishing packages, coordinate review, and track post-approval variations and labeling changes. Regulatory intelligence tools monitor guideline and requirement updates, assess portfolio impact and flag dossier readiness gaps. AI-assisted functions support document assembly and draft preparation for regulatory review. The platform connects with enterprise systems through documented integrations, including Veeva RIM, and is available for cloud, on-premises or hybrid deployment.

Zelthy Patient Services is a configurable platform for pharmaceutical and biotechnology manufacturers running patient support programs. It supports digital enrollment, patient onboarding, document collection and verification, eligibility screening, benefit verification, case management, care coordination, adherence support, and program reporting. Teams can configure workflows and coordinate activities across patient, care-team, and operations touchpoints. The platform also includes AI agents designed to review enrollment documents and prepare cases for staff review, alongside workflow automation for routine tasks. Patient services teams can use the system to manage program operations and track cases through their lifecycle, while commercial operations teams can monitor program activity and outcomes. The platform helps organizations operate patient support services using digital workflows.

Zelthy Traceability is pharmaceutical serialization and supply-chain traceability software for drug manufacturers and distribution teams. It supports assigning and encoding product identifiers, aggregating units into bundles, cases, and pallets, and tracking products through distribution to the last mile. Authentication and anti-counterfeiting workflows help verify products and manage suspicious activity, while regulatory reporting supports DSCSA, EU FMD, and India Schedule H2 requirements. The platform connects manufacturing and distribution records with supply-chain data to provide inventory visibility, demand and channel analytics, and exception monitoring, including stockout prediction. It also supports government portal data exchange and integrations with existing business systems. Deployments are configured around each organization's supply chain, markets, and compliance requirements.

Zelthy Commercial Operations is a commercial operations software suite for pharmaceutical and life sciences organizations. It brings together workflows for healthcare professional (HCP) engagement, field-force activities, clinic and distributor ordering, product sampling, and channel operations. Teams can coordinate commercial outreach, record and review field activity, manage ordering and distribution processes, and monitor operational performance across channels. The solution connects commercial teams and workflows with the systems used across pharmaceutical businesses, supporting day-to-day coordination from customer engagement through product distribution. Its configurable capabilities address different commercial processes and market requirements for field teams, clinics, distributors, and other channel partners.

Zelthy Advanced Therapies is a workflow orchestration solution for organizations coordinating cell, gene, and other advanced therapy programs. It connects operational activities across patient referral and enrollment, apheresis, manufacturing coordination, chain-of-identity and chain-of-custody tracking, scheduling, cold-chain logistics, infusion, and follow-up. Teams can manage handoffs among treatment centers, manufacturers, logistics partners, and care teams, while monitoring shipment status, temperature excursions, and exceptions. The platform supports configurable workflows, patient and stakeholder portals, case and task management, document and communication workflows, and integrations with existing enterprise and clinical systems. It is intended for therapy developers, manufacturers, providers, and treatment networks managing complex, multi-party journeys from collection through delivery and post-treatment care.

Zelthy Compliance is a compliance monitoring platform for pharmaceutical and life sciences organizations. It maps regulatory changes to affected policies, procedures, programs, and owners, while AI agents monitor business processes for potential risks. Teams manage policy and SOP lifecycles, audits, corrective actions, conflict-of-interest disclosures, outside-activity approvals, and escalations. A policy-grounded copilot provides answers linked to internal procedures and routes complex questions for review. The platform supports transparency reporting, including Sunshine Act, EFPIA, and Open Payments workflows, plus OIG, OFAC, and sanctions screening. Zelthy also describes modules for GxP documentation and 21 CFR Part 11 audit trails. Integration options include life sciences and business systems, REST APIs, SFTP, and webhooks. It is designed for compliance, ethics, and risk teams overseeing pharmaceutical operations.

Zelthy Platform is an application platform for pharmaceutical and other life sciences organizations to build, deploy, and operate business applications and AI-enabled workflows. Built on the open-source Zango framework, it provides reusable application templates, workflow and CRUD packages, role-based access controls, policy rules, audit logging, multi-tenancy, and a runtime for governed AI agents. Prebuilt agent blueprints cover use cases such as enrollment, patient detection, adverse-event monitoring, field-visit validation, document processing, and compliance checking. Development teams can extend the platform using Python and Django, retain control of application code, and deploy to cloud, private cloud, on-premises, or hybrid infrastructure. It is intended for life sciences engineering and operations teams creating applications for regulated processes.