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WHAT WE DO FOR YOU

ZENOVATIVE is focused on IT Compliance and CSV (Computer Systems Validation) solutions and services for the Life Sciences Industry.


COMPUTER SYSTEMS VALIDATION

Provide a high degree of assurance that your systems & processes will consistently meet GXP guidelines We are experts in providing guidance and resources for your CSV and related needs. We work to provide risk based validation solutions for our clients based on industry standards whilst following Regulatory Compliance Standards such as 21 CFR Part 11, Annex 11 etc.


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AUDITING FOR LIFE SCIENCES

Let Our Experienced Auditors Come and Work For You.

ZENOVATIVE SOLUTIONS works with clients in Auditing Services, let us audit for you, our seasoned team of auditors will leverage their experiences for your te the following types audits for our clients:

  • >> 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


Some of the clients we have audited in contractual and/or full time roles are:
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  • >> Takeda Pharmaceutical Group


  • >> Avara Pharmaceutical Services


  • >> Cytokinetics


  • >> Human Genome Sciences (GSK)


Audit Experience Highlights:-

  • >> Conducted clinical study close-out and remediation audits of CRO’s and clinical data management companies on behalf of sponsor for a critical Phase 2 clinical trial.

  • >> Conducted vendor qualification audits of major global IT Services providers for the Life Sciences Industry.

  • >> Conducted IT focused audits for Interactive Voice Response System and Electronic Data Capture vendors, as well as, radiological service provider for Mid-Tier Biotech.

  • >> Represented organizations in multiple FDA inspections, as well as, inspections by other regulatory agencies and partners.

  • >> Conducted multiple internal audits and gap assessments for GXP Compliance.

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GOVERNANCE & STRATEGY

IT & Organizational Alignment

  • >> IT Governance Program Development - Scaled / Aligned to Match your Organization

  • >> Quality System Development


  • >> Cloud Validation