Quarterly check point reports that outlines the below:
Operational status/metrics
Areas of improvement/observations
Short term course corrections/remediation
Validation Reports containing review comments of validation packages for releases
Validation Certificates
Validation metrics on open vs. closed validation observations with impact, criticality, and status
Validation Standard Operating Procedures (SOP), Work Instructions (WI), Guidance Documents, Templates Regulatory Adjustment/Remediation if required
Weekly and Monthly status updates on validation progress on each of the releases assigned
Determination of scope for subsequent quarter (agreed in conjunction with Medidata P&V leadership) for business continuity and improvement
About Virtusa
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