A robust compliance framework is vital to any GxP organization. Our compliance consulting practice develops compliance frameworks for GMP, GLP or GCP organizations. We assist our clients in implementing and evaluating specific programs. Another area of our expertise is developing master plans for new facilities and expansion projects.

Our auditing practice engages in evaluating or implementing compliance and quality assurance programs within existing facilities. The audit team performs vendor audits to evaluate software application vendors.

Some of our specific offerings are:

Master Validation & Project Plans (New Facility and Facility Expansions)

Develop corporate compliance and validation policies / procedures

GxP Auditing and Implementing of compliance programs like:

• Quality Systems Program
• Validation Program
• Problem Reporting & Corrective Actions Program
• Calibration Program
• Change Management Program
• Preventative Maintenance Program
• Production Records Program
• Training Program
• Quality Documentation & Control
• Security Management Program
• Supplier Evaluation Program
• Materials, Warehouse & Distribution Management Program
• Network Infrastructure & Information Management Program
• Policies, Procedures & Guidelines

Audit Vendors