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IT for Regulated Business

 Audit Preparation

Even the best compliance programs need continual attention and testing. Business and organizations are constantly evolving to meet changing market conditions. This inevitably leads to quick decisions, new systems and personnel movement sometimes resulting in procedure oversights. A good compliance program includes regular assessments to maintain audit readiness.

We begin by evaluating quality controls, key personnel responsibilities, procedure, systems, and records to ensure they are adequate for their intended use. Our audit preparation covers the following areas:

IT Management

  • Corporate policies
  • Guidelines and SOP Review
  • Document Control Systems
  • 21 CFR Part 11
  • Validation of Procedures
  • Employee and Vendor Training

Network Infrastructure

  • Configuration Validation
  • Access Control
  • Change Control and Documentation
  • Security Systems
  • Vendor Audits