Life Sciences Software Integrations & Consulting

Implementation, AI-powered workflows via MCP, and GxP validation for Egnyte in regulated life sciences environments. Hybrid cloud content governance with 21 CFR Part 11 compliance.

Implementation, AI-powered workflows via MCP, and GxP validation for Benchling in regulated life sciences R&D. Cloud-native ELN, Registry, Inventory, and Workflows with 21 CFR Part 11 compliance.

Implementation, AI integration, and GxP validation for MasterControl Quality Excellence and Manufacturing Excellence. Predictive CAPA analytics, deviation trend analysis, and closed-loop quality-manufacturing workflows.

Implementation, AI integration, and validation for the purpose-built MedTech eQMS. FDA QMSR and ISO 13485 alignment, design control and ISO 14971 risk traceability, AI-powered complaint triage and CAPA, and 21 CFR Part 11 validation.

Integration, AI enablement, and GxP validation for Clario eCOA, cardiac safety, medical imaging, and respiratory endpoints. Endpoint data-transfer pipelines to your EDC and data warehouse, AI-powered compliance monitoring, and 21 CFR Part 11 validation for clinical trials.

Implementation, InForm migration, AI integration, and GxP validation for Oracle Clinical One EDC, randomization and trial supply management (RTSM), and data collection. REST API and Digital Gateway pipelines to CTMS, safety, and data warehouses, plus 21 CFR Part 11 compliance for clinical trials.

Implementation, Argus migration, AI-powered case processing via MCP, and GxP validation for Veeva Vault Safety and the Veeva Safety Suite. ICSR intake, MedDRA/WHODrug coding, E2B(R3) gateways, aggregate reporting, signal management, and 21 CFR Part 11 compliance.

Implementation, Cortex AI integration via MCP, and GxP validation for Snowflake in pharma. Data pipelines from Veeva, SAP, and clinical systems. Secure data sharing and real-world evidence analytics.

Implementation, NavaX AI qualification, and GxP validation for ArisGlobal LifeSphere Safety (MultiVigilance), Regulatory, RIM, Clinical, and Medical Affairs. E2B(R3) reporting, signal detection, and 21 CFR Part 11 compliance for AI-augmented safety workflows.

Implementation, AI integration via MCP, and GxP validation for Honeywell TrackWise Digital and classic TrackWise QMS. Deviations, CAPA, change control, audits, supplier quality, and complaint handling — with SAP and LIMS integration and 21 CFR Part 11 compliance.

Reltio Velocity Pack for Life Sciences implementation, FERN AI matching, Veeva CRM and Salesforce integration, and downstream Snowflake/Databricks pipelines. Sunshine Act and EFPIA recipient registry, GDPR consent management, and GAMP 5 validation for pharma master data.

Implementation and integration of the full Dotmatics portfolio — Luma scientific intelligence platform, GraphPad Prism, SnapGene, Geneious, LabArchives ELN, and IDBS E-WorkBook/Polar. MCP-powered AI agents on R&D data, legacy chemistry registry migration, and GxP validation under GAMP 5.

Werum PAS-X MES implementation for biologics, sterile fill-finish, oral solid dose, and cell and gene therapy manufacturing. Master batch record authoring, SAP and LIMS integration via PAS-X Connect, PAS-X Savvy analytics, MCP-based AI agents for review-by-exception and deviation triage, and full GAMP 5 Second Edition validation with unified Part 11 and Annex 11 mapping.

Siemens Opcenter Execution Pharma (formerly SIMATIC IT eBR) implementation for biologics, sterile fill-finish, oral solid dose, and API manufacturing. Electronic batch records and review by exception, SAP / LIMS / SIMATIC PCS 7 integration via ISA-95, Opcenter Intelligence analytics, Siemens Industrial Copilot and MCP-based AI agents for deviation triage, and full GAMP 5 Second Edition validation with unified 21 CFR Part 11 and EU Annex 11 mapping.

Implementation, legacy ELN migration, integration, and AI augmentation for Revvity Signals Notebook (formerly PerkinElmer). Template and stoichiometry design with embedded ChemDraw, migration from BIOVIA, Dotmatics, and IDBS ELNs, LIMS and registration integration via the Signals REST API, MCP-powered AI agents for experiment search and SAR mining, and full 21 CFR Part 11, Part 58 GLP, EU Annex 11, and GAMP 5 Second Edition validation.

Validated SAS environment deployment (SAS 9.4, LSAF, Viya), CDISC SDTM and ADaM architecture, Define-XML metadata, AI-assisted clinical programming with Claude, GPT, and Gemini, SAS-to-R/Python modernization with the Pharmaverse, EDC and eCTD integration, and full 21 CFR Part 11, EU Annex 11, and GAMP 5 Second Edition validation for FDA, EMA, and PMDA submissions.

Implementation, AI integration, and GxP validation for LabVantage LIMS, ELN, SDMS, and SAPA cloud across pharma QC, biopharma R&D, and biobanking. SAP and MES integration, instrument connectivity (Empower, Chromeleon, OpenLab), Configuration Toolkit-driven deployments, ICH Q1 stability, ISO 20387 biobanking, MCP-powered AI agents, and full 21 CFR Part 11 and GAMP 5 validation.

Implementation, AI integration, and GxP validation for STARLIMS (Francisco Partners) across pharma QC, clinical diagnostics, and public health labs. SAP and MES integration, instrument connectivity (Empower, Chromeleon, OpenLab), HL7/FHIR clinical interfaces, MCP-powered AI agents, and full 21 CFR Part 11, EU Annex 11, and GAMP 5 Second Edition validation.

Implementation, AI integration, and GxP validation for the Certara stack — Phoenix WinNonlin and Phoenix Hosted for PK/PD, Pinnacle 21 Enterprise for SDTM/ADaM submission validation, Simcyp PBPK modeling, D360 scientific exploration, and the October 2025 Certara IQ generative-AI QSP platform. EDC and Vault RIM integration, MCP-powered agents for finding triage and CSR drafting, and full 21 CFR Part 11, GAMP 5, and BIMO inspection readiness.

Implementation, AI integration, and GxP validation for ValGenesis — the industry-leading Validation Lifecycle Management System used by 30 of the top 50 life sciences companies. iVal equipment & CSV validation, iClean cleaning validation, iOps electronic logbooks, iCMC process lifecycle, and the new Smart GxP AI platform. SAP/MES/QMS integration, MCP-powered AI agents beyond native VAL, and full 21 CFR Part 11, EU Annex 11, and GAMP 5 Second Edition validation.

Implementation, AI integration, and GxP validation for IDBS E-WorkBook (Danaher) and Polar across biopharma process development, analytical R&D, stability, and CGT CMC. LIMS/ERP/MES integration, chromatography data system connectivity (Empower, OpenLab, Chromeleon), MCP-powered AI agents and RAG over historical experiments, and full 21 CFR Part 11, EU Annex 11, and GAMP 5 Second Edition validation.

Implementation, AI integration with ELaiN, and GxP validation for the Sapio Sciences unified Scientific Data Cloud across pharma R&D, drug discovery, NGS and bioinformatics, clinical bioanalysis, biobanking, manufacturing QC, and CGT operations. No-code app builder configuration, instrument integration via Sapio Instrument Manager, MCP-powered AI agents, and full 21 CFR Part 11, EU Annex 11, and GAMP 5 Second Edition validation.

Study build, integration, AI enablement, and GxP validation for Suvoda — the IRT and RTSM platform purpose-built for oncology, rare disease, cell and gene therapy, and decentralized trial designs. Randomization schemas, drug supply forecasting, eConsent and eCOA configuration, EDC and CTMS integration with Medidata Rave, Veeva Vault CDMS, and Oracle Clinical One, and full 21 CFR Part 11, EU Annex 11, ICH E6(R3) GCP, and GAMP 5 Second Edition validation.

Implementation, integration, and AI enhancement for TraceLink — the largest digital supply network for pharma serialization. ERP and packaging-line integration (SAP ATTP, Werum PAS-X, Systech, Antares Vision, OPTEL), trading partner onboarding, global country reporting (DSCSA, EU FMD, Chestny ZNAK, ANVISA, Saudi RSD, iVEDA), AI agents for EPCIS exception triage and anomaly detection, and full GAMP 5 Second Edition validation aligned with 21 CFR Part 11 and EU Annex 11.

Optimization, ecosystem integration, AI enhancement, GxP validation, and migration-readiness for IQVIA Orchestrated Customer Engagement (OCE) — the Salesforce-built commercial and medical engagement platform serving 400+ life sciences companies across 130+ countries and now co-evolving into Salesforce Life Sciences Cloud (IQVIA support through 2029). OCE Personal, Digital, Content, Optimizer and OCE+ health checks; IQVIA OneKey reference-data sync, Salesforce platform API and Model Context Protocol integration, MDM, content and pharmacovigilance handoff to Oracle Argus and ArisGlobal LifeSphere; AI agents for call-note summarization, next-best-action, content recommendation and data-quality via Claude and GPT; vendor-neutral migration-readiness assessment to Salesforce Life Sciences Cloud; and full 21 CFR Part 11, PDMA / 21 CFR Part 203 sample accountability, EU Annex 11, Sunshine Act, and GAMP 5 Second Edition validation.

Implementation, integration, AI enablement, and GxP validation for Qualio — the cloud-native QMS purpose-built for emerging life sciences companies, CDMOs, and Class I-III medical device manufacturers. REST API and webhook integrations with NetSuite, SAP, Microsoft Dynamics 365, Arena PLM, PTC Windchill, LabWare LIMS, Benchling, and HRIS platforms; AI agents for CAPA root cause hypotheses and complaint triage via Claude, GPT, and Gemini; and full 21 CFR Part 11, EU Annex 11, ISO 13485, EU MDR, and GAMP 5 Second Edition validation.

Implementation, integration, AI enablement, and GxP validation for Florence Healthcare — the most widely deployed clinical research site platform, used by 17,000+ sites, sponsors, CROs, and academic medical centers worldwide. REST API and webhook integrations with Veeva Vault eTMF/SiteVault, Medidata Rave/eTMF, Oracle Clinical One, CTMS systems, IRT, and IRB platforms; AI agents for regulatory packet QC, TMF Reference Model auto-tagging, ICF amendment differencing, and BIMO inspection prep via Claude, GPT, and Gemini; and full 21 CFR Part 11, EU Annex 11, ICH E6(R3) GCP, and GAMP 5 Second Edition validation.

Modernization assessment, cloud migration to Documentum Cloud Edition, D2 configuration, AI enablement, and GxP validation for OpenText Documentum — the document-of-record platform across most of the world's top-25 pharma companies for regulatory submissions, eTMF, quality document control, and manufacturing batch records. Documentum REST API and Model Context Protocol integrations with SAP (Extended ECM), Veeva Vault, LabWare/STARLIMS/LabVantage LIMS, Werum PAS-X and Siemens Opcenter MES, and Office 365 co-authoring; AI agents for classification, regulatory query response drafting, SOP gap analysis, submission consistency checking, and conversational repository access via Claude, GPT, Gemini, and OpenText Aviator; and full 21 CFR Part 11, EU Annex 11, ICH Q9/Q10, and GAMP 5 Second Edition validation including risk-based categorization of legacy DAR/BOF/DFC customizations.

Implementation, migration, integration, AI enablement and GxP validation for the Veeva Vault RIM Suite — the unified cloud platform for regulatory information management used by global pharma, mid-size biotechs, generics and CROs. Vault object-model and lifecycle configuration; AI-assisted legacy archive migration; REST and Bulk API integration with Vault Safety, Quality and Clinical, ERP and IDMP/SPOR master data; eCTD publishing-validation triage and eCTD v4.0 readiness; MCP-powered AI agents for natural-language archive search, correspondence summarization and submission drafting; and full 21 CFR Part 11, EU Annex 11 and GAMP 5 Second Edition validation.

Implementation, migration, integration, AI enablement and GxP validation for Veeva Vault CTMS — the unified cloud clinical trial management system used by sponsors and CROs to run end-to-end study, country and site management, monitoring, issues and site payments. Study, country and site object-model and lifecycle configuration; AI-assisted legacy CTMS migration from Oracle Siebel and homegrown trackers; Vault EDC–CTMS connection plus REST and Bulk API integration with eTMF, Study Startup, safety and ERP; MCP-powered AI agents for natural-language trial search, monitoring visit report drafting, site risk triage and inspection-readiness checks against the TMF Reference Model; and full ICH E6(R3) GCP, 21 CFR Part 11, EU Annex 11 and GAMP 5 Second Edition validation.

Implementation, integration, AI enablement and GxP validation for LORENZ docuBridge — the market-leading electronic submission management and eCTD publishing platform with 2,000+ installations across pharma, biotech, generics and regulatory agencies. Edition selection (ONE/TWO/FIVE), publishing-profile and lifecycle configuration, built-in LORENZ eValidator integration, and eCTD v4.0 (HL7 RPS) readiness; connectors to Veeva Vault, OpenText Documentum, Egnyte and LORENZ drugTrack for registration and ISO IDMP master data; AI agents and Model Context Protocol integrations plus LORENZ verifAI for submission gap analysis, document classification, hyperlink verification and natural-language archive search via Claude, GPT and Gemini; and full 21 CFR Part 11, EU Annex 11, ICH M8 and GAMP 5 Second Edition validation including FDA Computer Software Assurance risk-based testing.

Implementation, integration, AI enablement and GxP validation for Waters Empower — the most widely deployed chromatography data system in pharmaceutical quality control. Empower Enterprise client/server architecture, LAC/E32 acquisition design, and instrument qualification; validated bidirectional interfaces to LabWare, STARLIMS, LabVantage and SampleManager LIMS plus NuGenesis SDMS via the Empower Toolkit web-services API; compliance-aware AI agents and Model Context Protocol integrations for audit-trail review-by-exception, manual-integration detection and OOS investigation drafting; data-integrity remediation against shared logins, over-privileged users and uncontrolled manual integration; and full 21 CFR Part 11, EU Annex 11, ALCOA+ and GAMP 5 Second Edition validation with FDA Computer Software Assurance risk-based testing.

Implementation, configuration, integration, AI enablement, and GxP validation for the Generis CARA Life Sciences Platform — the unified content and data platform that links Regulatory, Quality, Safety, and Clinical records in a single information space, spanning RIM, CMC, pharmacovigilance, GxP quality, non-clinical, and medical information. Content-model and workflow configuration via CARA's companion configuration platform; cloud-native CARA5 deployment on AWS/Azure/GCP and migration from OpenText Documentum with audit-trail preservation; eCTD publishing interoperability and integrations with SAP ERP, Oracle Argus safety, CTMS/EDC/eTMF, Snowflake and data lakes; Model Context Protocol AI agents extending native CARA AI for natural-language search, Module 2 and CSR drafting, label comparison, and signal detection via Claude, GPT, and Gemini; and full 21 CFR Part 11, EU Annex 11, ICH Q10, ALCOA+ data integrity, and GAMP 5 Second Edition validation.

Implementation, integration, AI enablement, and GxP validation for ETQ Reliance — the configurable, cloud-native enterprise quality management system used across pharma, biotech, and medical devices for document control, CAPA, nonconformance, audit, change control, supplier quality, complaint handling with eMDR, and environmental health & safety. ETQ Reliance Designer and ETQ Script configuration; REST API and OAuth 2.0 event-driven integrations with SAP, Oracle, Teamcenter, Windchill, LabWare/STARLIMS/LabVantage LIMS, and Werum PAS-X / Siemens Opcenter MES; custom MCP server and AI agents for predictive CAPA, deviation root-cause hypotheses, complaint triage, and supplier risk scoring via Claude, GPT, and Gemini alongside native Reliance AI; and full 21 CFR Part 11, EU Annex 11, 21 CFR Part 820 / QMSR, ISO 13485, EU MDR, and GAMP 5 Second Edition validation.