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Services – STEM Smart IT

Services

STEM Smart IT team is a diverse network of consultants and industry professionals with a global mindset.

Strategic Consulting Services

Cybersecurity

  • 24/7 Security Operation, Vulnerability Scanning
  • Email security setup and Management
  • Multi Factor Authentication (MFA), Single Sign On (SSO)
  • End point devices and infrastructure Backups for data loss prevention
  • Policies & SOP’s drafting for IT and Cybersecurity
  • Cybersecurity trainings
  • Vulnerability and Privileged Access Mgmt.
  • MDM - Device management, software deployment and patch management
  • Endpoints encryption for Windows and Mac devices
  • Penetration testing & remediation activities

Quality

  • QA Oversight and IT Project Management for GxP systems (Quality, Lab, Regulatory, Pharmacovigilance)
  • Develop and provide CSV/CSA services and approve deliverables for SaaS, IaaS, PaaS
  • GxP Computerized Systems Periodic Reviews, Release Mgmt to ensure validated state maintenance
  • Implement and Validate QMS, DMS, TMS (Quality, Document and Training Management) systems
  • Enterprise systems (LIMS, LES, CDS, SDMS/Integration Manager etc.)
  • Implement and manage SDLC for GxP systems according to GAMP guidelines
  • IT Vendor Audits
  • Liaison between IT and QA
  • Stand alone Lab systems (Rees, Softmax etc.)
  • Develop Equipment and Vendor Qualification Programs
  • Draft & update Change Controls, CAPA, Deviations & SOPs
  • SAP Validation

Core IT, Network Infrastructure, Helpdesk

  • Setup On-prem, Cloud and Wi-Fi network
  • Setup O365 setup and configuration, SharePoint document management and collaboration (BOX, OneDrive etc.). Folder taxonomy structuring and access management
  • Ticketing system setup - Manage helpdesk, Build laptops, Troubleshoot issues, Asset Management, Change Control of SOX, Non-GxP Apps, IT Support Metrics, SLA’s
  • Patching & Upgrading, Backup Monitoring
  • Onboarding & Offboarding processes, precise hardware and software inventory
  • Software installation, configuration and maintenance

PMO Office

  • Strategic program and project setup and management
  • Project Management tracking - Tasks, resources, due dates, risks, budget etc.
  • Develop and implement a standard project management methodology
  • Provide mentoring in initiation, planning, execution, and closing phases for project managers, managing one or more portfolios.
  • Periodic cadence with program stakeholders

Data and IT Governance

  • Data integrity program and remediation
  • Computer software assurance and validation
  • Risk assessment and vulnerability assessments
  • Security management and system administration
  • DI governance, policies and procedures
  • Data maps and business process mapping

We bring years of global experience to guide our clients through new and cutting edge technologies

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