Our Spotlights

On-site/Virtual Audit

Simplification of IT SOPs to have a precise procedure

Verification of IT controls in instruments/Equipment connected to computer systems of QC, Manufacturing

Drafting new SOP for IT process considering regulatory/guideline requirements

Enterprise Application compliance verification

Audit trail review to detect deletion/modification/unauthorized activities

CSV process/documents gap assessment

Provide any other ad-hoc services related to IT/CSV as per the customer’s requirement

Assessment of GxP Computerized system validation and 21CFR part-11 compliance.

Procedure Vs practice assessment

Data Backup & Recovery/Restoration Test assessment.

Audit readiness assessment

Assess Domain Group policy controls in GxP systems and implement best practices

Verification of user role, and privileges verification in GxP applications

Assess the Manual backup process of Non-Network systems and implement best practices