FDA Data Integrity & Part 11 Compliance

Get help from the expert who trains FDA on advanced data integrity

Cerulean’s managing director originally trained with the authors of FDA’s 21 CFR § 11 to inspect for Part 11 compliance then followed with a career building compliant departments, record & document control systems, and ensuring electronic data integrity.

For more than 20 years, he has successfully defended decisions against lawyers, auditors and inspectors alike, and rescued multiple clients from FDA inspections. Today, he trains FDA investigators and district directors on advanced data integrity topics and data fraud.

Get help from the expert who knows intimately both sides – the FDA’s and yours.

Cost-Effective Frameworks


Plus one full year of follow-up support and advice if you are ever audited or inspected.

Sample Downloads

More Resources

Email Cerulean today. We offer a free half hour consultation to new clients