IT compliance

Nivasoft is a provider of Regulatory Compliance and Validation Services for the regulated industry (Pharmaceuticals, Biotechnology, Medical Devices and Clinical Trials). We enable our clients to achieve compliance of their Systems with the regulatory requirements. We possess experience and have knowledgebase, tools and resources that are required for ensuring that our clients comply with regulation as they pertain to Computer and Laboratory Systems.

We understand regulatory requirements for Computer, Laboratory Systems, Infrastructure and provide Vendor/Partner Audits, Validation and Compliance support for some of the best companies in the business.

In the ever changing FDA regulated industries, you can count on Nivasoft as your partner to ensure that all necessary validation and compliance records are comprehensive, controlled, defensible and maintained as necessary.

Areas we work in

Software System And Application

  • Clinical Trials Systems
  • Drug Safety Systems
  • ERP Systems
  • CAPA Systems
  • Incident Management Systems
  • Document Management Systems
  • Learning Management Systems
  • Electronic Data Capture Systems
  • Manufacturing Systems
  • LIMS Systems

Laboratory Systems

  • HPLC’s
  • Chromatography Systems
  • UV Systems
  • Densitometers
  • Polarimeters
  • LIMS

Our Offerings

  • It Regulatory Complaince
  • Data Analytics
  • Business Intelligence
  • Software Development
  • Mobile Application Development
  • Salesforce
  • Servicenow
  • It Business Analysis
  • Project Management
  • Software Quality Assurance
  • Education And Training
  • Technology Staffing
  • Offshore Services
  • Forecasting & Assessment
  • Data Integration & Reporting
  • Data Integration & Business Intelligence Support
  • Tracking and Reporting Systems
  • Data Warehousing
  • Web Hosting
  • Compliance/Validation
  • Digital Analytics