About

We offer IT consulting services to the BioPharma industry, specializing in project and program management of global enterprise mission-critical systems, focusing in deployment, integration, computer systems validation (CSV), data migration, as well as software development life cycle (SDLC).

Technologies and solutions include:

  • Enterprise Resource Planning (ERP) - SAP, JDE

  • Learning Management Systems - SumTotal, ComplianceWire, Blackboard, Cornestone, Saba

  • Laboratory Management Information Systems - Beckman, ThermoLIMS, Labvange

  • Customer Relation Management - Microsoft Dynamics, Salesforce.com, SFDC ServiceCloud, and Veeva

  • Business Intelligence (BI) - Microsoft Azure, Amazon Web Services (AWS), Qlikview, Tableau, Cognos

  • Pharmacovigilence/Drug Safety - ArisGlobal

  • Regulatory Registration Tracking - ArisGlobal, Liquent

  • Data Aggregation - Capgemini LuquidHub

  • Document Management System (DMS) - Documentum, Veeva Vault, FirstDocs, IBM FileNet, OpenText

  • Project management - Microsoft Project, Clarity, Primavera, Asana, Zoho, Jira

Experience

  • Frameworks - Agile Scrum, DevOps, waterfall, spiral, evolutionary prototyping, and hybrid

  • L10N and I8N

  • 21CFR11 (e-signatures/e-records), GxP (GDP, GLP, GMP, GCP)

  • European Union ANEX 11

  • Risk based CSV

  • GAMP5