Services
STEM Smart IT team is a diverse network of consultants and industry professionals with a global mindset.
Strategic IT 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 and CSV (Computer System Validation)
- 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
