>> 21 CFR PART 11 SOLUTIONS

Our consultants are well versed in 21 CFR Part 11 and can work with your organization to develop a structured methodology for achieving 21 CFR Part 11 Compliance while leveraging a risk based, scientific approach. Our 21 CFR Part 11 services include:

 • Interpretation of 21 CFR Part 11 Federal Drug Administration (FDA) Regulation ruling
 • Development and execution of 21 CFR Part 11 Compliance Model
 • Development of system inventory
 • System regulatory and business risk assessment
 • Procedural and technical assessment
 • Analyze, plan, document and execute a strategy to correct (minimize) areas of non-compliant systems
 • Authoring of 21 CFR Part 11 policies and procedures
 • Development of Part 11 strategies for open/closed systems