Digital Transformation & eQMS

Modernize quality operations with validated digital systems that reduce manual risk, improve traceability, and enable audit-ready records. We manage vendor selection, computerized system validation (CSV), and rollout of digital SOPs and training for GMP environments.

 

Key offerings

• eQMS requirements, vendor selection and RFP management
   

• CSV strategy and execution (IQ/OQ/PQ for computerized systems)
   

• Digital SOPs, e-training modules and user-acceptance testing
   

• Data-integrity and electronic-records controls
   

Typical deliverables

• eQMS requirements specification and vendor comparison matrix
   

• CSV protocol suite and validation execution plan
   

• Digital SOP library and training records template
   

• Post-go-live validation report and data-integrity checklist
   

Client impact / outcomes

• Reduced documentation errors and audit findings related to records and traceability
   

Faster, auditable release and change-control workflows that scale with operations