FDA rolled the dice again in August 2003. They issued the final guidance and this is probably their road map to the final revised regulation. What does the current FDA thinking on Part 11 mean to pharmaceutical and biotechnology companies? Our Part 11 practice provides answers to these questions. Read More...

Service Offerings

Our Part 11 practice spans all functional areas within a pharmaceutical or a biotechnology corporation. We can develop a corporate wide strategy and implement it at a facility level. Our engagements have taken us through almost all facets of Part 11. Some of our specific offerings in the Part 11 realm are:

Part 11 Corporate-wide Planning Strategy

Part 11 Interpretation

Part 11 Gap Analysis

Part 11 Risk Analysis

Part 11 Remediation (Corrective Action) Planning

Part 11 Product Capability Analysis

Part 11 Corporate Policies, Guidelines Standards

Part 11 Training