Data Integrity Solutions

Ensuring Regulatory Compliance & Digital Trust

Overview

Pacific Group provides advanced Data Integrity Solutions designed to meet international regulatory standards such as USFDA 21 CFR Part 11 and ISO 17025. These solutions ensure secure, traceable, and compliant handling of electronic records and signatures, safeguarding operational transparency and regulatory readiness.

Deployed across more than nine major industries in Nepal, Pacific’s data integrity systems help businesses and labs maintain audit trails, prevent data manipulation, and align with global quality assurance frameworks.

Core Offerings

  • Audit Trail & Access Control Systems
    Secure logging of user actions and system changes, with role-based access
  • 21 CFR Part 11 Compliance
    Electronic records and signatures solution aligned with USFDA regulations
  • ISO 17025 Integration
    Support for lab accreditation processes with traceable data records and QA workflows
  • Training & Validation Services
    Industry-specific training modules and software validation for regulatory audits

Supporting Solutions

  • Quality Management Systems (QMS)
    Frameworks for maintaining standard operating procedures (SOPs), CAPA, and risk management
  • Document Management Systems (DMS)
    Centralized document version control, approval workflows, and compliance logging
  • Industry-Specific Training Programs
    Practical and technical training tailored to regulated environments such as pharmaceuticals, food testing, and clinical research