IT Audits & Assessments

One of Zenovative’s key focus areas is IT Regulatory Compliance

We are adept at Computer Systems Validation (CSV) / SQA (Software Quality Assurance) and Audits & Assessments solution for the LSH Industry.

Our experts identify your digital health and our experienced auditors work for you.

Our seasoned team of auditors will leverage their experiences with the following kinds of audits and assessments –

  • Part 11 System Audits
  • Vendor Qualification Audits for IT Software and Services Providers
  • Pre-Inspection Preparation and Audit Readiness
  • Lab Systems Audits/Assessments
  • Vendor Qualification Audits of CRO’s
  • Process Qualification Audits
  • Partner Qualification Audits
  • Internal Audits and Assessments
  • Remediation Audits for Data Integrity

Our team has audited for

  • Global Pharma: Takeda / Human Genome Sciences / Glaxo Smith Kline (GSK)
  • CMO: Avara Pharmaceutical Services
  • Biotech: Cytokinetics
  • Providers/Vendors Audited: CRO, IT Integrators/Data/Infrastructure
  • Providers, Lab Systems and Quality Systems Providers

Zenovative provides a proactive approach to IT regulations, governance and compliance. It’s a broad mandate that spans the way the IT function is governed; the tools, systems, technology – it uses; the number and nature of its connections business and risk are covered. A modernized and digital approach to compliance in the Life Sciences and Healthcare industry enables business leaders to stay ahead of regulations.

Comments are closed.