CSV/CSA

Software Testing is not merely about finding and reporting bugs but about enhancing quality, improving performance, reducing costs, cutting turnaround times and mitigating risks.

For the benefit of clients in the Life Sciences / Healthcare vertical, Vaisesika follows the principles of Computer Software Assurance (CSA) as against Computer Software Validation (CSV),  adopting a risk-based approach that limits testing to functions directly impacting product quality and patient safety.

Our Capabilities

REGULATORY COMPLIANCE

  • Regulations/Standards gap analysis & Remediation
  • Clinical Evaluation plan and Clinical evaluation report
  • Regulatory R&D for country-specific pre-compliance, verification, validation and certification, end-to-end risk management and design quality
  • Regulatory filing support

QUALITY MANAGEMENT SYSTEM

  • 21 CFR Part 11, compliance
  • QMS Development support
  • SOP Authoring/enhancement
  • Remote audits

PROCESS QUALITY

  • Process validation (IQ/OQ/PQ)
  • Test method Validations
  • Computer System Validations (CSV)
  • Change Management support
  • Train staff to promote company-wide adherence to QA protocols
  • Data Integrity and system-level assessment controls

VENDOR/SUPPLIER QUALIFICATION

  • End to End Supplier Management support
  • Supplier Audits and Qualifications & onboarding
  • Virtual monitoring on Investigations & CAPA closure
  • Change management

Application Types Validated

  • Enterprise SAP System
  • S4 HANA
  • SAP ECC 6.0
  • TOSCA
  • LMS
  • Document Approval process Validation
  • JD Edwards
  • ServiceNow
  • ServiceNow and Learning Management
  • RPA B0T
  • Certificate Authoring and Management Platform
  • IIQ Server Qualification
  • Enterprise QMS/EDMS System
  • Enterprise Misc System
  • Serialization Systems
  • Lab System

Tools We Support

Quality Management System

Change Management

LIMS

Test Management

Test Automation

CI/ CD

Try Our Self-Assessment

In our Computer System Assurance Self-Assessment. Your insights and feedback are invaluable in helping us ensure the integrity, quality, and regulatory compliance of our computer systems. 

Click Here to Start!

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